Hepatitis C Reader

H E P A T I T I S H A R M

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R E D U C T I O N

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A Background on Hepatitis Hepatitis A, B, C: What We Know

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by Joey Tranchina, MA, Tom O’Connell, MD & Steve Jenison, MD

HIV and HCV Coinfection

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by James Learned and Bonnie Goad

Hepatitis Counseling and Testing: Practical Guidelines for Providers

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by Kristen Ochoa, Paula Lum, MD MPH & Andrew Moss, PhD

Hepatitis C: A Medical and Psychiatric Disorder

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by Steven Kipnis, MD

Sex and the C Virus

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by Jeremiah Donovan, MD, FACP

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Hepatitis and Injection Drug/Alcohol Use Injection Drug Use and Hepatitis C

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by Brian R. Edlin, MD

Alcohol and Hepatitis C

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by Marion G. Peters, MD, MBBS & Norah Terrault, MD

Managing HCV among IDUs: Overcoming the Politics of Exclusion

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by Allan Clear

Policy Statement on Hepatitis C

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Harm Reduction Coalition

Dealing with Hepatitis: Some Facts for Injectors

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University of California, San Francisco, Department of Epidemiology & Biostatistics

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Taking Care of Your Liver:Treatment and Nutrition Hepatitis C Drug Therapy for People on Methadone Maintenance

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by Matthew Dolan

Treatment of HCV in the Methadone Patient

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by Diana L. Sylvestre, MD

Health Tips: Living with Hepatitis C

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by James Learned

Eastern Treatment Options: Traditional Chinese Medicine for HCV

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by Misha R Cohen, OMD, LAc

An Herbal Approach to Managing Hepatitis C

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by Donna Odierna

Liver Biopsy

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by Douglas T. Dieterich, MD

Diet and Hepatitis C

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by Jocelyn Rodriguez, MPH, RD, CDN

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Hepatitis C: It’s Impact on Our Communities Hepatitis C in African Americans

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by Andrew J. Muir, MD, MHS

Treatment Denied: Inmates and Hepatitis C

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by Charlie Seller

HEPC Advocates and Activists Needed

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by Alan Franciscus

Additional Resources

Back Cover

Compiled and edited by Paul Cherashore, Designed by James Pittman. Illustrations: Cover and pages 19, 23, 25, 27 and 39 by Joshua Gabriel; pages 9 and 36 by Michael Winikoff; page 31 by Bert Gossen. Photos on pages 11 and 16 by Paul Cherashore.

It

is just over a decade that we have a name for hepatitis C, and even less time that we have

diagnostic tools that show its presence in the body. Given that hepatitis C progresses slowly—it may take

decades for liver damage to manifest—it is difficult to predict what therapies will be most beneficial over the course of the disease. Most people who contract HCV will not die of it; most will develop chronic hepatitis but will otherwise live a normal life span. Quality of life is dramatically decreased for some patients, not at all for others.

In the Spring of 1998 HRC ran its first collection of articles in Harm Reduction Communication addressing the hepatitis C epidemic in injection drug users. Five years have passed and although we haven’t had sea changes in our knowledge of the disease, there has been some marked progress. In the intervening years our understanding of transmission has grown a bit, interferon treatment has been refined, with treatment success rates almost tripling, and there has finally been the beginnings of a shift in the medical profession’s views on the treatment of active users. (Unfortunately we still don’t have a treatment that works well without nearly destroying the patient’s health.)

For this reader we’ve included an interesting range of articles that touch on some of the issues that we think are important: HCV-HIV co-infection, HCV in the methadone patient, treatment access for current users and prisoners, patient advocacy and activism, issues facing policy-makers and some nuts ‘n bolts information on traditional, alternative and holistic HCV treatment. While the above list doesn’t pretend to be all-inclusive, it’s certainly a good starting point; additional resources are listed on the back cover.

Hepatitis C is a complex ilness; even if you have all of the facts, deciding how to address it can be excruciatingly difficult. We’ve attempted to shine a bit of light on the subject. While it may not make the decision—whether to undergo the current treatment, wait for new medicines, try alternatives to Western medicine or do nothing—easier, the added knowledge can help inject a bit of confidence into the decision-making process.

1 A Background to Hepatitis Hepatitis What we know

By Joey Tranchina, MA and Tom O’Connell, MD Postscript by Steve Jenison, MD

Reprinted fromHarm Reduction Communication, Spring, 1998 A to B... epatitis is literally “inflammation of the liver.” In this article, we will be focusing on what is known about the hepatitis caused by certain viruses, as opposed to inflammation caused by other agents, such as bacteria, parasites, or chemicals. Research initially identified two diseases caused by different viruses; hepatitis A (HAV) and hepatitis B (HBV).

It is known that most people get hepatitis A by drinking water or eating food contaminated with the human stool.

HAV tends to occur in areas where sewage treatment and water purification are a problem. It is not common for drug users to get hepatitis A infection. Rimming poses a sexual risk of HAV transmission.

HAV can make you very sick (nausea, vomiting, jaundice) for a couple of weeks but it does not cause long-lasting liver disease, unless there is HCV co-infection in which case HAV can cause fulminant liver failure. For this reason, the HAV vaccine is especially important if you are already infected with hepatitis C, (see the section on “HCV testing, treatment and management”).

HBV is similar to HIV in the ways it is spread. You can get it from sharing needles and from having sex. Newborn babies can get hepatitis B at birth from their mother if their mother is infected. 95% of infected newborns with immature immune systems become asymptomatic chronic HBV carriers.1 For adults, the big difference between hepatitis B and HIV is that most people who get hepatitis B will recover completely. They may be very sick when they first get infected, but more than 90% of adults who get hepatitis B will get rid of their infection within a few weeks. They will not have any more problems from hepatitis B, and will never get infected with hepatitis B again. A few people (5-10% or less) develop long-lasting (“chronic”) disease from hepatitis B that can lead to cirrhosis or liver cancer. People with chronic HBV are very infectious to other people for many years.

An HBV test and vaccine are available. It is worth getting tested for hepatitis B so that you know if you have: • Never been infected with HBV (and should get the hepatitis B vaccine); • Been infected with HBV in the past but have completely recovered; or • Been infected with HBV and have developed chronic hepatitis, in which case you should ask your doctor about medicines—like Epivir (lamivudine, or 3TC), adefovir dipivoxil and alpha interferon—that are available to treat your liver disease.

H

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…and then to C In 1989, the virus causing a third form of hepatitis (“non Anon B”) was identified as hepatitis C virus (HCV). Like HIV, HCV appears capable of mutating and six major genotypes of HCV have now been identified.

HCV and illness Most of the estimated 4,000,000 Americans with HCV face a far more hidden and serious illness than that produced by either hepatitis A or B. The most common symptoms of initial infection are malaise, weakness and anorexia: jaundice is less common. These symptoms may disappear, but for about 85% of HCV-infected people the virus establishes long-term residence in their blood, liver and other organs and they remain infected with HCV for the rest of their lives. The symptoms produced by this chronic infection vary. It seems to lead to an increased susceptibility to many other illnesses, and there is a complex relationship with auto-immune diseases.

Sixty to eighty percent of people with this long-term HCV infection will develop chronic active hepatitis. About 20% of those infected with chronic hepatitis C will develop cirrhosis (dense scarring) of the liver within 20 years, particularly those who are heavy users of alcohol. HCV-induced cirrhosis is now the most frequent indication for liver transplantation in the United States. About 20% of those with cirrhosis will develop liver cancer (hepatocellular carcinoma).

HCV transmission HCV can be spread through contaminated blood or tissue fluid, but since 1992 blood-screening has nearly eliminated transmission via transfusion or blood products. Spread to and from healthcare workers is possible, but is minimized when standard procedures (including gloves) are used. The sharing of injecting equipment by injecting drug users represents the most important mode of infection. The prevalence of HCV infection among injection drug users in the United States has been tested at 100% in at least one group (Anchorage, AK), and is estimated to be between 60-80% nationally.

HCV is much more easily transmitted via contaminated needles and syringes than HIV because it is hardier and more abundant in host blood. Even when needles or syringes are not directly shared, HCV seems to be transmitted by small amounts of contaminated blood in other injection equipment which is shared, e.g., water, cookers. Beyond injection, there is evidence that communal snorting of cocaine or heroin, when sharing the device used for snorting, allows enough blood-to-blood contact to (potentially) transmit the virus. However, the risks of communal snorting are nowhere near as great as communal inject-

ing and haven’t been quantitatively assessed. Sexual transmission of HCV does occur but is thought to be much less common than with HBV or HIV. Similarly, the rate of placental transmission from an HCV-infected mother to her baby is very low, about 5%, and it is usually safe to breast-feed. (Note: this rate rises to about 16% for HIV co-infected mothers.)

HCV testing, treatment and management There is no vaccine for hepatitis C, but an HCV blood test is available. Pegylated interferon, a synthetically made—and longer-acting—version of a hormone produced by the body to fight virus infections, is prescribed in injectable form to treat HCV, in conjunction with ribavirin, an anti-viral agent (typically for 6-12 months). However, this treatment is ineffective for some people either because it does not work or because of intolerable side effects. Research is currently being conducted into HCV protease inhibitors.

Complementary therapies are used by people to address their symptoms of HCV, including vitamins and minerals, Chinese herbs and other herbal teas and preparations. These therapies are used on their own or in conjunction with interferon/ribavirin, in part to mitigate its side effects. (An Herbal Approach to Managing Hepatitis—pp.

C 30-31—has more on this.) There are several ways that people with HCV can stay healthy. An Australian study of 104 people living with HCV reports that the most frequently used methods to stay healthy were (in descending order) reducing alcohol intake, changing the diet, reducing stress through meditation or exercise and changing drug injecting behavior, either by not sharing or reducing or stopping injection. Secondary prevention measures, such as not sharing toothbrushes and razors, and not donating semen or organs, are also important.

Steve Jenison adds: Hepatitis C has probably been infecting people and causing liver disease for centuries. But the virus that causes hepatitis C was first discovered about 10 years ago, so we haven’t had much time to study it. Some things about hepatitis C are fairly well understood, but there are other things about it that we are still learning. We know that hepatitis C virus is very different from the hepatitis B and A viruses. Hepatitis C, hepatitis B and hepatitis A are not related to each other at all. They are all viruses and they all cause hepatitis, but they’re not in the same family. They’re not even distant cousins. For example, hepatitis A is related to the virus that causes polio, hepatitis B is related to viruses that cause hepatitis in woodchucks and ground squirrels, and hepatitis C is related to the viruses that cause yellow and dengue fever. So it’s not surprising that they behave differently from each other in some ways.

Hepatitis C infection is very common among injection drug users. In many parts of the United States, between 80 and 90% of drug users are infected. Most of them become infected within 6 months after starting to shoot drugs. If you look at the entire population of the United States, only about 2% of people are infected. Sharing needles is the big risk for getting hepatitis C, both because the virus is passed easily that way and because so many users are infected. About 60% of all people in the U.S. who are infected with hepatitis C got infected through shooting drugs.

Some people get infected through having sex with someone who’s infected with hepatitis C, but it’s much less common than with hepatitis B or HIV. If you’re having sex with someone who has HIV or hepatitis B (or if you have HIV or

hepatitis B), a condom should definitely be part of the action.

With hepatitis C, it s not so clear that sex involves such a big risk. But in most cases, condoms are still a good idea because of the risks of hepatitis B and HIV. Day-to-day contacts with other friends and housemates should be safe as long as they don’t involve sharing needles. (Ed note: If you live with some one who has hepatitis C, avoid sharing razors, toothbrushes,- nail clippers, etc.—all items that could retain blood.)

One particularly bad thing about hepatitis C infection is that once you’re infected, you tend to stay infected for the rest of your life. Up to eighty-five percent of people who become infected with hepatitis C will develop a smoldering liver disease that goes on for many years; the other 15 or so percent apparently recover from the infection. If you look at all people who have chronic hepatitis C infection, about 20% of them will develop cirrhosis of the liver within 20 years of first becoming infected. About 5% will develop liver cancer in that same period of time.

To find out if you’re infected with hepatitis C, you can have a simple blood test done. There are at least three good reasons for knowing if you have hepatitis C. First, we know that people with hepatitis C can protect their liver by not drinking alcohol. At most you should drink only one drink a day, but it’s even better not to drink alcohol at all (including beer and wine). Second, you should get vaccinated against hepatitis A and hepatitis B. These infections can be especially dangerous in someone who already has hepatitis C. Third, you’ll know whether you should talk to a doctor about getting treatment for hepatitis C. We still don’t have an ideal treatment for hepatitis C, but progress is being made. Treatment response rates have improved dramatically over the last few years, from an average of about 20% for the original interferon regimen to about 35% for the interferon/ribavirin combination to above 50% for pegylated interferon/ribavirin. Unfortunately, these drugs are very expensive, and still don’t work in a lot of people who take the treatment; many others can’t tolerate the side effects.

New medications for hepatitis C infection may be available in the next few years. Drug companies are working hard to develop hepatitis C protease (pronounced PRO-tee-ace) inhibitors, similar to the powerful medicines that are used to treat HIV. For now, you need to seek out the advice of a health care professional that really understands the issues surrounding hepatitis C. It may be best for you to get pegylated interferon/ribavirin combination treatment now, or it may be better for you to wait until the next generation of hepatitis C medicines become available. Progress is being made rapidly in our understanding of hepatitis C and how to treat it. If you have a hepatitis C infection, stay informed and involved as much as possible.

If your doctor or nurse needs more information about hepatitis C, there are a number of excellent websites—see the list on the back cover. There is also a new publication: NumedxHepatit.isTo subscribe email subscribe@numedx.com or fax a request to 847-676-3184.

This article was prepared from information provided by Joey Tranchina, Executive Director of the AIDS/Hepatitis Prevention ACTION Network Inc.; Tom O’Connell, M.D.; Dr. Steve Jenison M.D., Medical Director of the HIV/AIDS Section, Infectious Diseases Bureau, New Mexico Department of Health.

1. Lee W, Hepatitis B iVrus Infection, New England Journal of Medicine; 1997; 337: 1733-45

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HIV and Hepatitis C Coinfection

by James Learned and Bonnie Goad

Adapted fromUnderstanding Hepatitis C: A Training for Service Providers (July 2003). Training created by AIDS Community Research Initiative of America (ACRIA) for New York City Department of Health and Mental Hygiene Prevalence and Epidemiology of Co-infection ecause HIV and HCV are blood-borne viruses, they affect many of the same populations.

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• In the United States, an estimated 200,000 persons are infected with both HCV and HIV. • Studies estimate that as many as 25-30% of HIV positive people in the U.S. are co-infected with HCV and up to 10% of HCV positive persons are HIV infected.

• In urban areas of the U.S., up to 90% of persons who acquired HIV infection from injection drug use also have HCV. • In New York, 78% of persons with HIV who report injecting drug use are also HCV-infected.

Both HIV and HCV can be transmitted by blood-to-blood contact, unprotected sex, and from a mother to her infant; however, the efficacy of transmission by these routes varies.

HCV is 10 times more infectious than HIV by direct bloodto-blood contact. This explains the higher incidence of HCV infection among IDU’s. For this reason, and because HCV infection was common in urban areas of the U.S. for decades before HIV was discovered, most HIV/HCV co-infected injection drug users were likely infected with HCV years before HIV. In contrast, studies have found that HIV is more transmissible than HCV between sexual partners and from a mother to her infant. Studies have found low rates of transmission to long-term monogamous sexual partners of HCVinfected persons. Even among persons engaging in high-risk sexual activity with multiple partners, the rates of HCV transmission are significantly lower than the rates of HIV transmission. However, the risk of sexual transmission of HCV appears to be increased when a person also has HIV. This could be because immuno-suppression caused by HIV may increase HCV viral load, and higher viral load may increase the risk of transmitting HCV. Without anti-HIV treatment, HIV is transmitted from mother-to-infant at rates as high as 20-30%. In contrast, HCV is transmitted to only 2% to 5% of infants born to HCV positive mothers. In most cases, however, the incidence of mother-to-infant HCV transmission increases if the mother is co-infected with HIV with rates reported as high as 20%.

There is no treatment available to HCV+ pregnant women to decrease the likelihood of transmission.

Impact of Co-Infection Effect of HIV on HCV Disease Most studies indicate that people with HIV/HCV co-infection experience faster progression to cirrhosis and more liver damage than people who are infected with only hepatitis C. Faster progression may be less likely if the individual’s HIV disease is well under control. A weakened immune system allows HCV to replicate faster, and higher HCV viral load makes a person more infectious. Co-infected persons with less than 200 T-cells are at a much higher risk of developing cirrhosis, liver failure and liver cancer, also called hepatocellular carcinoma (HCC).

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Effect of HCV on HIV Disease It is still unclear if HCV accelerates HIV disease but, in most cases, it does not appear to. Studies of people with hemophilia who are co-infected have shown alarming rates of HIV disease progression, but other co-infected populations do not appear to experience this effect. HCV may affect the course of HIV by increasing the incidence of liver toxicity caused by HAART. Persons with badly damaged livers may have a hard time breaking down HIV medications, especially protease inhibitors and non-nucleosides. This can lead to less antiviral activity, a higher HIV viral load, a lower T-cell count, and, over time, limited HIV treatment options. As people live longer with HIV, many more HIV deaths are caused by HCVrelated end stage liver disease.

Treating Co-Infected Persons Persons considering treatment should consult with healthcare providers well versed in HIV and HCV treatment. Referrals to specialists (such as gastroenterologists, hepatologists, and/or infectious disease doctors) are an important part of making informed decisions. In some cities there are medical clinics that specialize in co-infection.

Deciding which infection to treat first, HCV or HIV, can be difficult. The treatments for HCV have not been specifically approved by the FDA for the treatment of HCV in HIV-infected persons, although they are commonly used in co-infected people. In addition, there are no published studies of the most effective way to treat co-infected persons.

Most physicians work to get HIV under control first. With reduced HIV-related disease progression as a result of HAART (Highly Active Anti-Retroviral Therapy), the decision of who should be treated for HCV (and when) is often determined by:

• the likelihood of beneficial response to treatment • the likelihood of adverse reactions to the medications • the risk of progression of liver disease While questions about when to start treatment and which treatment to start first are still unresolved, there is important information that should be considered when making treatment decisions: • Many individuals who are co-infected do not respond as well to HCV therapy as persons who are infected only with HCV. Factors affecting a person’s response to HCV therapy include age, HIV viral load, CD4 count, HCV viral load, HCV genotype, condition of the liver, and alcohol intake.

• Protease inhibitors and non-nucleosides are processed through the liver. Persons beginning HIV anti-viral treatment often experience an increase in HCV viral load and liver enzymes. In most cases, this flare-up will go away relatively quickly. Regular bloodwork is particularly important during the first couple of months after starting any antiviral treatment.

• Ribavirin and Retrovir (AZT) can both cause severe anemia in many people, therefore it may be best to avoid using both drugs at the same time. Combivir and Trizivir also include AZT and should likewise be avoided in combination with ribavirin.

• Nucleoside analogues can damage mitochondria, which produce energy for cells. Ribavirin is a nucleoside analogue as are AZT, d4T (Zerit), ddI (Videx), ddC (Hivid), 3TC (Epivir) and abacavir (Ziagen). Mitochondrial toxicity may be more likely in persons taking ribavirin in addition to other nucleoside analogues.

• If ribavirin and ddI (Videx) are used together, particular caution is in order! People taking both drugs have a five times greater likelihood of developing mitochondrial toxicity than people taking ribavirin with other nucleoside analogues.

• Viramune (nevirapine) has been associated with an increased risk of liver damage in people with hepatitis C, although not all co-infected people will experience liver problems from this drug. Signs of liver problems usually begin within three months after initiation of use.

• Regular liver function tests are important to monitor the

Most studies indicate that people with HIV/HCV co-infection experience faster progression to cirrhosis and more liver damage than people who are infected with only hepatitis C.

impact of treatment, especially the first 2-3 months after starting a new drug therapy.

• Interferon has been associated with increased irritability, insomnia and suicidal ideation. Because depression before and while on treatment is common, co-infected persons who are considering therapy that includes interferon are strongly encouraged to have a support network in place which includes a mental health professional and /or support group.

• High doses of interferon can lower T-cells (CD4s), at least temporarily, although the CD4 percentage is not usually affected. Although interferon can benefit people’s immune response to hepatitis C, it may be harmful to the immune response of some people with HIV. All persons co-infected with HIV and HCV should be: • seen by physicians knowledgeable about both HIV and HCV. • provided with information to maintain liver health.

• counseled about the impact of alcohol on the progression of liver disease.

• counseled on ways to reduce the transmission of HIV and HCV. • vaccinated against HAV and HBV, if not previously exposed.

• evaluated for chronic liver disease, including HCV viral load, genotype, LFT’s and perhaps a biopsy.

• considered for HIV and/or HCV antiviral treatment as needed.

• counseled about drug interactions and side effects of HCV and HIV treatments.

HEPATITIS C AND HIV ARE DIFFERENT VIRUSES Hepatitis C

HIV

Hep-C is the hepatitis C virus

HIV is the Human Immunodeficiency Virus that causes AIDS.

Hep-C is more common among injectors, (among injectors, hep-C infection rates may be close to 90%)

HIV is less common among injectors

Hep-C produces far more copies of itself than HIV, so there is much more of it in the bloodstream. This makes it more likely that someone exposed to hep-C will get infected.

HIV produces far less copies of itself than hep-C, so there is much less of it in the bloodstream. This makes it less likely that someone exposed to HIV will get infected.

A high amount of the hep-C virus in your system does not guarantee you will get sick sooner.

A high amount of HIV in your system may mean you will get sick sooner.

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Hepatitis Counseling and Testing Practical Guidelines for Providers

By Kristen Ochoa, Paula Lum, MD, MPH and Andrew Moss, PhD

Reprinted fromHarm Reduction Communication, Spring, 1998

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n 1985, publicly funded HIV antibody counseling and testing services were initiated as a tool to encourage HIV prevention. Though little was known at that time about the prevalence and natural history of HIV infection, providers saw that linking testing and counseling together was important in helping persons interpret the meaning of test results.

Today, we are faced with a similar problem with hepatitis C (HCV). A serologic test for antibodies to HCV became available for the first time in 1990, and many people are just now learning that they have hepatitis C. Knowledge of transmission, however, is limited and few treatment options exist.

Although HCV is not as uniformly fatal as HIV, the diseases bear many similarities in their viral etiology (origins) and genetic diversity, their blood borne transmission, a chronic course, and the absence of definitive cure or preventative vaccine. How do you do hepatitis test counseling in this climate? What constructive messages and prevention tools exist? In an effort to provide hepatitis testing and counseling to young injection drug users, we have developed some strategies for staff counselors and medical providers aimed at providing hepatitis education, risk assessment and disclosure in a harm reduction setting. (These general guidelines may also be adapted for screening for hepatitis B.) Objectives of Hepatitis C Counseling and Testing 1. To provide a convenient opportunity and comfortable environment for persons to learn their current HCV serostatus.

2. To provide information to those who are infected with HCV: secondary prevention, evolving treatment options and strategies for slowing disease progression.

3. To identify persons who are unaware or uninformed about their risk of infection for hepatitis HCV and to foster within the individual an understanding of their personal risk and options for prevention.

4. To prevent further spread of HCV by informing people of their status and risks.

Necessary Elements of Hepatitis Test Counseling, Testing, and Referral Services Outreach: We must start by finding people, and reaching out to them. As simple as this may sound, many current and former IDUs are not aware of their risk or their status for HCV and would not enter testing without outreach.

Outreach should go to where people are, raise consciousness, and offer easy access to HCV-related services.

Maintenance of Confidentiality: Just as anonymity and confidentiality are important aspects of HIV testing, so should they be in hepatitis testing. Assign, or have the person choose a unique identifier (letters or a number) so that you can do follow-up.

Education: This should start during outreach and be developed by the test counselor. Begin with the ABCs of hepatitis.

How are hepatitis A, B and C different from one another

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(many people confuse them)? How are they transmitted?

What options exist for hepatitis A and B vaccination? Why are we concerned about hepatitis now—who has it and who’s at risk?

Risk Assessment: In risk assessment, the counselor responds to the individual’s needs for reducing his or her harm in general and his or her risk for HCV in particular.

Consider whether or not the person could be in the window period for HCV (2-8 weeks). Focus should be on assessing where the person is now in terms of risk and developing a harm reduction strategy for reducing future risks.

Harm Reduction: Focus on the individual’s goals and offer viable, incremental options for change relevant to his or her life. Validate their current attempts, while recognizing and clarifying the relevant, remaining risks or places to grow. A risk assessment form should be developed for each person with space for a harm reduction plan.

Disclosure/Interpretation of Test Results: Providing HCV antibody (ELISA-3 or EIA-3 are the most commonly used) test results is challenging in light of the many questions that remain about HCV transmission and treatment. Unlike tests for HBV infection, antibody tests for HCV cannot distinguish between current acute infection, chronic infection, or past resolved infection.1 For the person who is HCV negative, the harm reduction plan should be completed with guidance from the counselor. For HCV positive people, several secondary prevention tools exist which are important in disclosure: reducing alcohol use, getting into regular care and getting vaccinated for hepatitis A and B to prevent co-infection. HCV positive patients with HAV co-infection can develop fulminant liver failure.2 Co-infection with other viral illnesses, such as HIV and HBV, may cause faster HCV disease progression.

False-positive HCV test results are more likely to occur in low prevalence populations, such as blood donors. This group should receive supplemental testing with HCV RNA PCR testing to confirm or rule out HCV infection. In highrisk populations, such as injection drug users, the accuracy of the commonly used HCV tests is 88-95% and does not require supplemental testing.1 False negatives happen more frequently with people who have HIV/AIDS, or other immune weakening conditions (for example: diabetes, transplant and dialysis patients).

Vaccination and Referral: Vaccination against hepatitis A and hepatitis B for those who are eligible should be available on-site or at a convenient community-based organization.

Fortunately, there are few adverse effects from these vaccines.

The person’s decision whether or not to receive vaccinations, however, is also part of the harm reduction discussion and plan. Developing a referral network with health care providers who also use a harm reduction approach is helpful.

Outreach workers should be available for accompaniment or advocacy during appointments if the client requests.

Clinicians and outreach workers should collaborate on following-up with clients so that they may complete their vaccination series.

Kristen Ochoa is Project Coor dinato,r Paula Lum, MD, MPH is Medical Director and Andrew Moss, PhD is Principal Investigator for the “UFO Study,” a collaborative ojepr ct between the UCSF Department of Epidemiology and Haight Ashbury Youth Outreach in San Francisco. The project seeks to measure theoser prevalence hepatitis B, hepatitis C and HIV in injection drug users under age 30, and to provide hepatitis A and B vaccination, follow-up and community-based outreach. For more information contact Kristen at (415) 206-5693/email: kochoa@itsa.ucsf.edu or Paula at (415) 597-4965/email: plum@itsa.ucsf.edu.

1. Summary of the NIH Consensus Development Conference Statement on the Management of Hepatitis C, June 1997.

2. New England Journal of Medicine, 1998; 338: 286-90.

Hepatitis C A Medical & Psychiatric Disorder

by Steven Kipnis, MD Reprinted from the website of the NYS Office of Alcohol Substance Abuse Services (OASAS)

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epatitis C virus (HCV) infection is the most common cause of chronic liver disease in the United States.

Approximately 4 million Americans are positive for the HCV antibody; 75% have had a positive HCV RNA test and are chronically infected. Of the chronically infected patients, 15% will develop cirrhosis. Five percent of those with cirrhosis may develop primary cancer of the liver (hepatocellular carcinoma).

Patients with alcohol and drug abuse present significant medical challenges. However, HCV patients present with a critical psychiatric component that must be recognized and addressed. An Italian study published in Gastroenterolgyin 1996 by Taruschio et al. showed that 36.7% of HCV patients had a psychiatric disorder. Patients with the HCV infection have been found to be more likely to have psychiatric disorders than other viral hepatitis patients. For psychiatric disorders associated with hepatitis C, etiologies are categorized to understand this co-morbid relationship: • HCV infection alone • HCV treatment utilizing interferon causing the disorder • Liver transplantation, rejection and re-infection As this breakdown shows, not only is the disease associated with psychiatric co-morbidity, but the treatments are also known to have significant neuropsychiatric adverse effects.

HCV and Depression In various published studies, data show that up to 30% of HCV patients have a diagnosis of depression; 60% of these patients require treatment. The reason for the high rate of depression in HCV patients is unknown, though some believe that they may suffer from a reactive depression related to excessive fatigue or concerns about their long-term prognosis. Additional risk factors for depression relate to their concurrent substance abuse.

An article by Johnson et al. in the American Journal of Gastroenterology in 1998 compared depressive symptomatology of drug users with HCV who have not received interferon treatment to non-infected substance abusers. It was found that 57.2% of HCV-positive subjects who were using drugs had significant depressive symptoms. This is compared to 48.2% of non-infected substance abusers who showed significant depression. The study concluded that depression associated with interferon treatment might at least, in part, be accounted for by a pre-existing depression, especially in the substance abuser. These studies led to the rec-

ommendation that screening for anxiety and depression should occur before starting HCV treatment protocols.

Interferon and Psychiatric Disorders Interferon alfa-2b, as used in HCV treatment protocols, has a mechanism of action that is not completely understood, but andappears to work as an antiviral and immunomodulatory agent interfering with viral replication and enhancing the ability of the immune system to recognize and attack the virus.

There are many adverse effects seen with the use of interferon which have a medical and psychiatric overlay. It is also important to consider that the interferon therapy may amplify symptoms of an underlying depression. In addition, chronic flu-like symptoms, gastrointestinal distress and alopecia (all potential side effects of the HCV therapy) can all have a profound impact on the psyche.

The described neuropsychiatric side effects occur in greater than 20% of the interferon treatment population and include: • Depression • Irritability • Somnolence • Insomnia • Suicidal ideation Renault (Archives of Internal Medicine , 1987) described psychiatric side effects of interferon that fell into three categories: Organic personality syndrome: • Irritability • Short temper Organic affective syndrome: • Extreme emotional lability • Depression • Tearfulness Delirium: • Clouding of consciousness • Agitation • Paranoia • Suicidal potential These symptoms can appear one to three months after starting interferon treatment and can improve in three to four

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days after decreasing interferon. The symptoms resolved when therapy was stopped. The organic syndromes were seen in patients with the highest doses of interferon; delirium occurred in patients with severe hepatitis who also had previous organic brain injury, organic brain dysfunction or previous alcohol or substance abuse.

Why Does One Develop Depression from Using Interferon?

The pattern of personality changes suggests that the dysfunction is in the frontal-subcortical area of the brain. There is also a possibility of interference with or changes in the neurotransmitters of the brain, especially serotonin. Research has shown that patients treated with interferon have altered serum levels of tryptophan, a precursor of serotonin. (In fact, the decrease in serotonin could lead to an interferon-induced dementia syndrome.)

There may also be an effect of interferon on the serotonin transporter. Clinically, the use of selective serotonin reuptake inhibitors (SSRI), such as Paxil®, have been shown to work on the serotonin transporter level and treat the depression induced by interferon.

Duration of treatment with interferon may also play a role in the development and intensity of the depression.

Compliance with the medical regimen may be affected if the depression is not aggressively treated. Interferon-induced depression carries substantial risk of suicide with one reported case of suicide after the discontinuation of interferon.

Further, interferon side-effects tend to look like opiate-withdrawal symptomatology and one has to investigate the possibility of relapse and the onset of depression seen in active drug use.

Treating Depression from the Use of Interferon The seriousness and frequency of the depression indicates the need for constant monitoring and vigorous treatment.

Investigation into the treatment of interferon-associated depression has involved the use of opioid-receptor antagonists, stimulants and antidepressants (especially the SSRI group as previously noted). One study, reported in the New England Journal of Medicine , pretreated the patients before the initiation of interferon therapy, using paroxetine two weeks before the onset of treatment. Two of 18 (11%) of the paroxetine group developed depression, compared to 9 of 20 (45%) in those who did not use paroxetine. (It should be noted, however, that this study was in melanoma patients and the results may not be applicable to hepatitis C. Also, the doses of interferon were larger than those used in hepatitis C treatment regimens.)

An approach for assessing and managing the patient with interferon-induced depression has been published by Zdilar et al. and suggests the following: • Inform the patient about the risk of interferon-induced depression.

• Educate the patient to recognize symptoms of depression.

• Explain treatment options.

• Arrange a psychiatric evaluation before treatment, if: current or previous history of depression history of psychiatric hospitalization history of substance/alcohol abuse or dependence family history of depression/suicide attempt.

• Treat depression before starting interferon.

• Start interferon after depression is in remission.

• Closely monitor while on interferon therapy.

• Actively treat alcohol and substance abuse.

• Watch for alcohol and substance abuse relapse.

10

• Regularly screen with the BDI, Zung or other depression tool.

• At each visit, ask about depression, suicidal ideations.

• If depression develops during treatment, treat depression aggressively.

• Interferon can be continued if depression is not severe.

• If depression does not respond to antidepressants, the interferon dose should be decreased.

Note: It is noted that ribavirin, another medication used in HCV treatment, does not appear to aggravate the neuropsychiatric side effects of interferon.

Transplantation and Psychiatric Disorders In 1995, almost half of the liver transplants were performed on patients infected with HCV. The potential for adverse mental health consequences in the face of a physical illness is well recognized and the psychiatric distress of a chronic illness is frequently associated with a compromised quality of life.

Psychiatric evaluation is suggested in all transplant patients prior to transplant, especially to help them deal with emotional and behavioral disorders that may reduce the chance of successful outcomes, as well as issues of anti rejection regimens and death.

In the work by Gayowski et al., the HCV patient undergoing transplantation showed more depression, mood disturbances and psychological stress than non - HCV transplant patients. This did not occur due to a greater severity of liver disease and, in fact, the HCV patients showed a greater level of fatigue, loss of appetite, weight loss, sleep problems and pain.

Complicating the transplantation picture is the problem of recurrence of HCV after transplant, as shown in the work

by Singh, et al. He reported that 41% of HCV patients had a recurrence of HCV infection after transplantation; 12 months after transplant, these patients showed a significantly poorer quality of life with worse depression and a lower physical function than other transplant patients.

Medication Issues, Psychiatric Disorders and HCV When treating patients with hepatitis, one must be aware of the possibility of altered hepatic function leading to an altered metabolism of medications, especially antidepressants. The changes in metabolism could lead to toxicity. In a patient with liver disease and compromised liver function, encephalopathy can develop due to an inability to handle dietary protein. The use of antidepressants of the tricyclic class can cause impairment in the thinking processes due to their anticholinergic effects, adding to the encephalopathic impairment. A clinical picture of delirium can ensue. The use of benzodiazepines can worsen the delirium.

Recommendation It is critical for physicians and counselors to quickly recognize the pre-existing depression, or depression caused by hepatitis C or the side effects of HCV pharmacologic therapy! They must be treated with supportive therapy, modification of doses of interferon and psychiatric medications.

Failure to do so may result in limitation of therapy, noncompliance with therapy and serious personal, interpersonal and mental health consequences.

Steven Kipnis is Medical Director of NYS Office of Alcohol and Substance Abuse Services. This article is also avaible at: http://www.oasas.state.ny.us/AdMed/pubs/FYIInDepth-HepC.htm.

Sex and the C Virus

By Jeremiah Donovan, M.D., F.A.C.P.

Reprinted from HCV Advocate’s Medical Writers’ Circle , a publication of the Hepatitis C Support Project. Visit their web site at http://www.hcvadvocate.org.

H

epatitis C is a bloodborne pathogen and a frequent cause of chronic viral hepatitis in the world. The World Health Organization estimates that around 170 million people worldwide are infected with hepatitis C.1 A large amount of information has been delineated from the National Health and Nutrition Examination Survey (NHANES III) conducted between 1988 and 1994 regarding how many people in the United States are estimated to be HCV antibody positive (~3.9 million) and how many have HCV-RNA in their blood (~2.7 million).2 The Centers for Disease Control have been collecting data about the number of acute cases of hepatitis C virus infection each year (~25,000 new cases in 2001).3 According to the CDC epidemiological data they estimate the source of infection in around 15-20% of acute cases is derived “sexually”—making this the second most common reason for infection behind intravenous drug use.

This number seems to be in stark contrast to the data regarding your risk of contracting hepatitis C if your sexual partner is HCV positive.

So why is there this seeming discrepancy between these two pieces of information? Hopefully, in this paper, I will be able to shed some light on this. I want also to give information to patients about the risk for their sexual contacts possibly becoming infected, and how to best assess and deal with this risk.

Sexual Activity as a Risk Factor for Having Hepatitis C Many epidemiological studies throughout the United States and Europe have shown that a large percentage of people infected with the hepatitis C virus deny the use of IV drugs.

Some studies asked, “have you ever used IV drugs,” and some asked, “have you used drugs in the past six months prior to the onset of your being noted to be HCV positive.”

Obviously there is a big difference in these two situations. It is known that at least 70% of people who have used IV drugs are hepatitis C positive, and that after 5 years of IVDU over 90% are HCV positive.

Obviously, some of these people may have been HCV positive previously for reasons other than sex, but this doesn’t explain why those people who have never used intravenous drugs are positive.

Also when one looks at patients of sexually transmitted disease clinics, a higher proportion than that seen in the general population are HCV positive, including those who report never having used IV drugs. The greater number of sexual partners a patient reported correlated with the likelihood of being HCV positive. Data collected from the NHANES III study showed that people who had more than 49 sexual partners during their lifetime had a prevalence of 9.4% for the HCV antibody. The prevalence decreased with lower numbers of sexual partners (see table 1). One of the problems

TABLE 1: Prevalence and Relative Risk of Being HCV Positive Based upon the Number of Sexual Partners in Your Lifetime NO. OF PARTNERS

# TESTED

PREVALENCE %

95% CI

RELATIVE RISK

0-1

2808

0.6

0.3-1.0

1.0 (95% CI)

2-9

5545

1.6

1.1-2.2

2.54 (1.14-5.66)

10-49

2299

3.3

2.6-4.3

2.54 (1.14-5.66)

≥50

454

9.4

5.6-15.8

5.16 (1.8-14.73)

Modified from Alter, M. NEJM 341:556-62,1999. 8

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with the NHANES data is that the use of IV drugs was not asked about in the questionnaire. So is a large number of sexual partners a surrogate marker for IV drug use? Maybe, in part; but we won’t be able to answer that question here. The NHANES study did ask about intranasal cocaine use and marijuana. A positive response to these questions also was reported in a higher frequency in those who were HCV positive than in those who were hepatitis C negative.

This is not to say that hepatitis C virus is not spread to sexual partners, but is it spread through intimate sexual activity? Previous studies have not been able to demonstrate the presence of HCV-RNA in body fluids except for blood.4 However, more recently, there have been reports of the presence of the hepatitis C virus RNA in the semen of up to 1/3 of HCV viremic men.5 The levels are low, but, nonetheless, were positive. This may explain the lower rates of infection in sexual partners of patients with HCV than what is seen with other sexually transmitted viruses, such as Hepatitis B and HIV. Whether it is the act of sexual intercourse that is the cause of the transfer of the HCV virus to a person who was previously uninfected is not known, and may never be, since there are no good animal models for HCV infection except for humans and chimpanzees. We do know that in Chayama’s study the hepatitis C virus RNA sequence pattern is the same in both partners in two pairs of long-term monogamous couples without a history of previous IV drug use.6 Thus, as best we can tell, it is possible that the hepatitis C virus could be spread through sexual intercourse, but, perhaps, because of the lower amounts of virus in semen, the rate of transmission is lower than if there were a blood to blood transfer of virus. Also, there has been a study that showed evidence of the hepatitis C virus in cervical smears.7 Other epidemiological data have shown a higher prevalence of hepatitis C in women and men who are engaged in sexual behavior for money, and in men who have sex with men. This higher prevalence over the rest of the US population persists even when one controls for other variables, such as IV drug use and HIV infection.

‘So What is My Risk?’

Epidemiological studies are nice for the CDC and physicians, but, as a patient, I want to know—if I have hepatitis C what is the risk that my partner/spouse is going to become infected?

Several studies in several patient populations have been performed to look at the question of how frequently a sexual partner of a hepatitis C patient becomes hepatitis C positive. The studies are limited to a certain degree by two major factors. One is that phenomenon I call “birds of a feather.”

What I mean by this is that people are going to be with people who have similar interests and activities. So some couples may both be HCV positive because of past risky behavior.

Whether that be sharing needles in IV drug use, intranasal cocaine use, or other activities. The basal prevalence of HCV may be slightly higher than or at least equal to that of the general population. The other factor is, have the couples had sex before the blood sample collection and observation periods began? In most studies yes; therefore, how many of those HCV positive partners became infected sexually may not be determinable. In spite of these problems when one tries to sort out the relative risk for a partner of a hepatitis C infected patient becoming infected there are some data to suggest the risk is low but not zero.

A study was conducted of 398 couples, each couple consisting of a hemophiliac male and his partner. Of the 398 males 343 were positive for HCV and HIV, 42 for HCV alone and 6 for HIV alone and 2 with neither virus. In this study, blood samples from the patients and their partners were collected at baseline in 1982 and then every 6-12 months for the next 6 years. At the beginning of the data collection 5 couples were eliminated from the study because of a history of past IV drug use by the female partner. Of the remaining 393 couples, 52 (13%) of the 393 were HIV positive at the beginning of the data collection. All 52 women’s husbands were HIV positive. Nine women seroconverted to HIV positive during the 6 years of data collection. At the start of the data collection 22 (5%) of the 393 women were HCV positive. Only 1 partner of the 42 men with HCV alone became

TABLE 2: Incidence of Partner Seroconversion by Risk Group STUDY POPULATION (AUTHOR)

NUMBER OF PATIENTS AND PARTNERS

LENGTH OF STUDY

INCIDENCE OF SEROCONVERSION

Prospective-Rome STD clinic (Guiliani)11

709

1 to 3.7 years

1.25 per 100 person-years

Mean 12 months Mean 46 months 17 years

6 per 1000 person-years 2.3 per 1000 person-years 1 per 10,000 person-years

13 years

0 per 1000 person-years

15.6 years

3.86 per 1000 person-years

21.4

1 per 1000 person-years

Prospective cohort monogamous heterosexual couples Italian (Piazza) 13 499 Taiwan (Kao)14 112 Ireland (Meisel)12 94 Retrospective Cohort monogamous heterosexual couples German Hemophilia 50 (Bresters)15 Italian dialysis or 83 liver clinics (Scotto)16 Austria (Neumayr) 17 80

Modified from Terrault, N. Hepatology 2002.Vol 36,No 5, S99-S105.18

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HCV positive during the 6 year follow up. However of the 343 men who were dually infected with HIV and HCV, 20 women became HCV positive (6%).9 From information obtained from sexually transmitted disease (STD) clinics, we know that HIV and HBV infection transmission is enhanced in the presence of genital ulcerations or other sexually transmitted diseases. This has not been clearly proven in the case of HCV. However, the numbers of patients with a previous IV drug use and who were excluded from analysis in these studies from STD clinics studied were very high and may have limited the ability of these studies to find such an association.

When one looks at the males who were the sexual partners of women who had HCV in a Baltimore STD clinic, the risk of the men becoming HCV positive over time was no different in the men who had an HCV positive partner or who had a partner that was negative for the hepatitis C virus. This suggests, as do other studies, that if transmission from sexual activity does occur it occurs less frequently from a positive female to her sexual partner than from male to female, or male-to-male. A female partner of a male patient in that clinic had a 3% risk of having hepatitis C if the man were HCV negative and a 10% chance of having HCV if he were HCV antibody positive. 10 In a STD clinic in Rome, 709 patients and their partners were followed for 1 to 3.7 years prospectively. In this study 16% were HIV positive, 2.1% admitted to IVDU, 34% were men having sex with men. Their partners had an incidence of becoming HCV positive of 1.25 per 100.11 This low frequency of transmission of the hepatitis C virus from a woman who is infected to her male partner is supported by the data from Ireland of the 2533 women who received contaminated anti-D globulin after childbirth. 94 male partners of 86 women with chronic hepatitis C were followed for 10-15 years. None of them developed antibodies to the hepatitis C virus.12 Reports from other authors suggested that the male sexual partners had a 0.2% risk of becoming infected with hepatitis C in 17 years. This equates to a rate of 1 in 10,000 infections in the sex partner per year.

To try to make sense of the risk of transmitting hepatitis C infection from a male to his sexual partner, or from a female to her sexual partner, please see table 2.

Taking this information into account, it appears that sexual transmission may occur, or at least that the sexual partners of patients with hepatitis C may be at risk to become infected with the hepatitis C virus. There are studies that have shown HCV RNA in semen and in vaginal secretions in a low amount, in patients with hepatitis C. But as seen in table 2, if the virus is spread through sexual contact, it does not happen very frequently. Factors that may increase the risk of sexual transmission of hepatitis C are having HIV coinfection, a low CD-4 count, having sex with a male who is HCV positive, and having multiple sex partners.

So, to answer the question posed at the beginning of this section, “What is the risk that I will spread this virus to my spouse or sexual partner?” The answer should be that if you are in a monogamous relationship then the risk of your spouse or lover becoming HCV positive is about 1 in 1000 to 1 in 10,000—that is provided that you are not HIV positive.

The risk is about three times higher for a woman to become infected if her male partner is HCV positive than for a man who has a female HCV positive partner. So, it is not zero—but it is a fairly low chance.

What can you do to protect your spouse or lover?

The recommendations of the CDC are that if you are in a monogamous relationship with a person then you don’t have to do anything different than what your normal practice is.

You do not need to wear condoms if you choose not to.

However, if 1 chance in 10,000 is too high then maybe you should consider the use of condoms. I leave that decision up to you as a couple. If you are not in a monogamous relationship then you should be using condoms, not necessarily to protect your partner, as much as to protect yourself.

How often should your spouse or sexual partner be tested for hepatitis C? Most of us recommend that the partner of a person with hepatitis C be screened for the antibody to the virus. Some authors have suggested that they then be tested repeatedly approximately every two years but most physicians have not made that recommendation because of the low incidence of conversion from HCV antibody negative to HCV antibody positive (seroconversion) in this population unless they have other risk factors.

While sexual transmission of the hepatitis C virus may occur, it does so infrequently. Just how often it is difficult to say, but hopefully I have provided some useful information that will help us counsel our patients about the risks of HCV as a sexually transmitted disease.

References 1. WHO Press Release/36 1 May 1998.

2. National Center for Health Statistics. Plan and Operation of the Third National Health and Nutrition Examination Survey 1988-1994. Washington, DC: National Center for Health Statistics; July 1994. Vital and Health Statistics, series 1, No32.DHHS publication 94:1308.

3. MMWR. May 2,2003. Page xvi.

4. Freid MW, Shindo M, Fong T-L, et al. Absence of hepatitis C viral RNA from saliva and semen of patients with chronic hepatitis C. Gastr oenterology 1992; 102:1306-8.

5. Leruez-Ville M, Kunstmann JM, De Aldmeida M, et al. Detection of hepatitis C virus in the semen of infected men. Lancet 2000; 356:42-43.

6. Chayama K, Kobayashi M, Tsubota A, et al. Molecular analysis of intraspousal transmission of hepatitis C. J Hepatol 1995; 22: 431-9.

7. Manavi M, Watkins-Reidel T, Kucera E, et al. Evidence of hepatitis C invicer cal smears. J Infect 1999; 38:60-61.

8. Alter MJ, Kruzon-Moran D, Nainan O, et al. The prevalence of hepatitis C usvir in the United States. N Engl J Med. 1999; 341:556-62.

9. Hisada M, O’Brian TR, Rosenberg PS, et al. J Infect Dis 2000; 181:1475-8.

10. Thomas DL, Zenilman JM, Alter HJ, et al. Sexual transmission of hepatitis C virus among patients attending sexually transmitted diseases clinics in Baltimor eAn analysis of 309 sex partnerships. J Infect Dis 1995;171:768-75.

11. Guiliani M, Caprilli F, Gentili G, et al. Incidence and determinants of hepatitis C virus infection among individuals at risk of sexually transmitted diseases attending a human immunodeficiency virus type 1 testing program. Sex Transm Dis 1997; 24:533-7.

12. Meisel H, Reip A, Faltus B, et al. Transmission of hepatitis C virus to childr en and husbands by women infected with contaminated anti-D immunoglobulin.

Lancet 1995; 345(8959): 1209-11.

13. Piazza M, Sagliocca A, Fazio V, et al. Sexual Transmission of hepatitis Cusvir and efficacy of prophylaxis with intramuscular immune serum globulin. ch Ar Intern Med 1997; 157:1537-44.

14. Kao JH, Liu CJ, Chen W, et al. Low incidence of hepatitis C transmission between spouses: a prospective study. J Gastr oenterol Hepatol 2000;15:391-5.

15. Bresters D, Mauser-Bunschoten E, Reesink H, et al. Sexual transmission of hepatitis C virus. Lancet 1993; 342: 210-11.

16. Scotto G, Savastano L, Tosome G, et al. Sexual transmission of the hepatitis C virus infection. Eur J Epidemiol 1996; 12: 241-4.

17. Neumayr G, Propst A, Schwaighofer H, et al. Lack of evidence for the sexual transmission of hepatitis C. QJM 1999; 92: 505-8.

18. Terrault NA. Sexual activity as a risk factor for hepatitis C. Hepatology 2002; 36: no 5, S99-105.

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2 Hepatitis and Injection Drug/Alchohol Use Injection Drug Use and Hepatitis C Practical Guidelines for Providers

By Brian R. Edlin, M.D.

I

njection drug users (IDUs) constitute the largest group of persons infected with the hepatitis C virus (HCV) in the United States, and most new infections occur in IDUs. Controlling the HCV epidemic, therefore, will require developing, testing, and implementing prevention and treatment strategies that will be effective in persons who inject drugs. Preventing morbidity and mortality from HCV will require reducing exposure to HCV, reducing infection among those exposed, and reducing disease among those infected.

Injection drug use could be greatly reduced if all those who needed substance abuse treatment could get it (prevention of exposure). HCV spread among drug users can be prevented if drug users have access to sterile syringes, HCV counseling and testing, and outreach programs that teach them how they can avoid acquiring and transmitting the virus (prevention of infection). Finally, barriers to medical treatment must be overcome so that drug users can benefit from advances in HCV treatment (prevention of disease).1 HCV treatment may also reduce transmission (prevention of infection), because HCV-infected IDUs are the source for most HCV transmission in the United States. Efforts are particularly important to identify persons with new HCV infections, in whom treatment may be more effective during the acute phase than later,43 and those with advanced hepatic fibrosis, in whom treatment may improve survival.

Caring for drug users presents special challenges to the health care team that require patience, experience, and tolerance. Fortunately, substantial research and clinical experience in the prevention and management of chronic viral infections among IDUs, especially HIV infection, has led to the development of effective principles for engaging drug users in health care relationships (Table).2-5 Learning from this experience will be critical for efforts to control HCV. Successful programs invariably adopt a respectful approach to substance users, understand the medical and behavioral sequelae of addiction, and refrain from moralistic judgments.

These strategies reflect a harm reduction approach.6,7 Harm reduction strategies help patients reduce high-risk behaviors without imposing unrealistic demands for global change.

When ceasing all drug use is not likely in the immediate future, other measures must be taken to help patients reduce the harmful consequences of injection drug use.8,9 Decisions about the treatment of HCV infection in patients who use illicit drugs, as in other patients, should be made by

14

the patients together with their physicians based on individualized risk-benefit assessments.1 Adherence, psychological side effects, and the possibility of reinfection present challenges to effective treatment for some drug users.

Fortunately, an array of effective strategies exists to overcome each of these challenges. Attention to ensuring optimal adherence is important for all patients, not just those who use drugs.10 This is so because although certain risk factors for noncompliance have been identified, including depression, psychological stress, homelessness, lack of social support, and drug use, physicians are not able to predict accurately which patients will adhere to a treatment regimen.11 Effective strategies for improving adherence range from basic clinical practices—such as establishing a consistent, trusting physician-patient relationship, providing clear information about intended effects and side effects of medication, and paying careful attention to perceived side effects—to specialized tools such as electronic reminder systems, directly observed therapy, and cash incentives.12-17 Simplifying complex treatment regimens, treating depression, or helping a homeless patient find housing can help improve adherence. Patients may also benefit from counseling addressing individual barriers to and facilitators of adherence in the patient’s life.

The psychological side effects of interferon-based regimens for the treatment of HCV infection are of concern in all patients. Interferon may have severe psychological side effects in patients with or without pre-existing psychiatric disorders.18-19 To minimize psychological toxicity, all patients should be screened for depression and other mental health conditions before undergoing HCV treatment, treated for these conditions if necessary, and monitored for them during HCV treatment.

Because those successfully completing HCV therapy may be at risk for reinfection, drug users need detailed counseling and support to avoid risky injection practices in case they continue or return to injecting drugs. Those who inject drugs after receiving effective treatment for HCV infection can avoid reinfection by using a new sterile syringe for each injection and by not sharing their injection equipment with other users. 20,21 There are one hundred seventy-four syringe exchange programs in one hundred twenty cities in thirtyfour states in the United States, and the number is increasing yearly. For drug users without access to such programs, physicians in at least forty-six states are allowed by law to prescribe syringes so that their patients can avoid acquiring and transmitting bloodborne infections.22-24 IDUs can master safe injection practices, and many do inject safely. When given access to sterile syringes, IDUs readily make use of them, reducing their high-risk behavior 25-27 and rates of dis ease transmission.28,29 Physicians should refer patients who inject drugs to syringe exchange programs or, if necessary, prescribe syringes for them. HCV may be more readily transmitted than the human immunodeficiency virus (HIV) through the sharing of injection equipment other than

syringes, such as “cookers” (bottle caps, spoons, and other containers used to dissolve drugs) and “cottons” (filters used TABLE Principles for managing health care relato draw up the drug solution into a syringe).30 Thus, it is partionships with substance-using patients. ticularly important for physicians to instruct their patients not to share these items.20,21 All injection drug users should be offered treatment for 1. Establish a climate of mutual respect. substance abuse and such treatment should be provided to 2. Maintain a professional approach that reflects the aim those wishing it. Medical services should be integrated with of enhancing patients’ well-being; avoid creating an substance abuse treatment. 3 Alcohol treatment is particularly atmosphere of blame or judgment. important because of the strong effect of heavy alcohol intake 3. Educate patients about their medical status, proon the progression of hepatitis C. Finally, all patients with posed treatments, and their side effects.

HCV infection should be instructed in how to avoid transmitting the infection to others. Patients should be warned 4. Include patients in decision-making. that their blood may be infectious even in minute quantities.

5. If possible, establish a multidisciplinary team consistThose who inject drugs should be instructed not to share ing of primary care physicians, HIV specialists, psychiasyringes or any other injection equipment with other persons trists, social workers, and nurses. and to avoid blood contact with others. They should be given 6. Have a single primary care provider coordinate the biohazard sharps containers or instructed to safely dispose of care delivered by such a team to maximize consistency injection equipment in puncture-resistant containers. 31 and continuity.

Clinical Data 7. Define and agree on the roles and responsibilities of There is abundant evidence that when treatment strategies both the health care team and the patient. for drug users take into account the circumstances of their 11,15—17,32-38 8. Set appropriate limits and respond consistently to lives, very high rates of adherence can be achieved. behavior that violates those limits.

Several recent studies have demonstrated the safety and effectiveness of hepatitis C treatment in drug users, even 9. Minimize barriers to participation (penalties for when they are not completely abstinent from drug use.39-41 missed visits, etc.).

Backniund et al. reported a thirty-six percent sustained viro10. Recognizing that patients must set their own goals logic response rate in fifty injection drug users who were for behavior change, work with patients to achieve treated simultaneously for HCV infection and substance commitment to realistic goals for healthier behaviors. abuse, even though eighty percent of the patients relapsed to 11. Acknowledge that abstinence is not always a realisdrug use.39 Sustained response rates were not significantly tic goal; emphasize risk reduction measures for patients different for patients who relapsed and those who did not. who continue to use drugs.

All patients were treated and supervised by physicians who 1 2. Acknowledge that sustaining abstinence is difficult specialized in both hepatology and addiction medicine. and that success may require several attempts.

Patients who relapsed to drug use were offered opiate 13. Be familiar with local resources for the treatment of replacement therapy and were allowed to continue their drug users.

HCV treatment even if they injected heroin again. The strongest predictor of virologic response was whether patients continued to keep their appointments; forty-five percent of those who kept at least sixty-seven percent of their appointments but only six percent of those who did not had sustained virologic espornses who relapsed to injection drug use after sustained virologic (emphasis added).This study demonstrates the importance of responses to HCV treatment. 41 combining expertise in both hepatology and substance abuse Success in treating HCV infection in IDUs will require coland maintaining strong relationships with patients that can be laboration between experts in hepatitis and substance use to sustained even through relapse to drug use. create programs specifically designed for drug users. Efforts Sylvestre et al. have treated sixty-seven methadone mainto control HCV, including both prevention and treatment, tenance patients with combination interferon/ribavirin, with can benefit from the expertise of those with experience workan interim sustained virologic response rate in the first fiftying with drug users. Substance abuse treatment professionals nine patients of twenty-nine percent, a rate identical to that have expertise working with drug users in treatment. Harm in a comparison group of nonopioid-dependent patients.40 reduction workers and many substance abuse researchers No serious side effects occurred, although sixty-one percent have expertise working with out-of-treatment drug users. of the patients had a prior psychiatric diagnosis. Response And many AIDS medical providers have expertise providing rates were not significantly different in patients who did or medical care to drug users both in and out of substance did not have six months of sobriety, nor in patients who did abuse treatment. Involvement of these professionals in HCV or did not consume alcohol. They were not significantly prevention and treatment efforts will greatly improve their worse in patients who continued using drugs unless they effectiveness. used every day. This study demonstrates that HCV can be A sound policy for the control of the hepatitis C epidemic effectively treated in patients receiving maintenance opiate will require implementing prevention and treatment proreplacement therapy despite substantial pre-existing psychigrams designed for IDUs, the group most severely affected by atric disease and despite ongoing, intermittent drug use. the epidemic.42 Controlling the HCV epidemic, therefore, Finally, Backmund et al. reported no reinfection during will require further research to develop and test prevention twenty-four weeks in ten patients who continued to inject and treatment strategies that will be effective in persons who heroin.39 They carefully instructed their patients how to inject drugs. In the meantime, however, substantial progress avoid acquiring HCV when injecting drugs. Dalgard et al. can be made to control hepatitis C if existing knowledge and reported one reinfection during five years in nine patients resources are brought to bear.

15 15

and Human Services, 2001. Available from URL: http://www .hivatis.org/guid- e lines/adult/text/adherence.html.

14. Reiter GS, Stewart KE, Wojtusik L, et al. Elements of success in HIV clinical care: multiple interventions that promote adherence. Topics in HIV Medicine 2000;8:21-30.

15. Bamberger J, Unick J, Klein P, Fraser M, Chesney M, Katz MH. Helping the urban poor stay with antir etroviral therapy. Am J Public Health 2000;90:699701.

16. Lorvick J, Thompson S, Edlin BR, Kral AH, Lifson AR, Watters JK. Incentives and accessibility: a pilot study to promote adherence to TB prophylaxis in a high-risk community. Journal of Urban Health 1999;76:4617.

17. Chaisson RE, Barnes GL, Hackman J, Watkinson L, Kimbrough L, Metha S, Cavalcante S, Moore RD. A randomized, controlled trial of interventions tooimpr ve adherence to isoniazid therapy to prevent tuberculosis in injection drug users. Am J Med. 2001;110(8):6105.

18. Renault PF, Hoofnagle JH, Park Y, et al. Psychiatric complications of tlongerm interferon alfa therapy. Arch Intern Med 1987;147:157780.

19. Janssen HL, Brouwer JT, van der Mast RC, Schalm. SW. Suicide associated with alfainterferon therapy for chronic viral hepatitis. J Hepatol 1994;21:2413.

20. U.S. Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Rockville, NO: Agency for Healthcare Research and Quality, 1996:591.

Available at URL: http://www .ahcpr.gov/clinic/2ndcps/drugab.pdf.

21. HIV prevention bulletin: medical advice for persons who inject illicit ugs.dr Rockville, MD: Public Health Service, May 9, 1997. Available at URL: http://www.edc.gov/hiv/pubs/hiv_prev.pdf.

22. Burris S, Lurie P, Abrahamson D, Rich JD. Physician prescribing of sterile injection equipment to prevent HIV infection: time for action. Ann Intern Med 2000; 133:218-26.

23. Rich JD, Macalino GE, McKenzie M, Taylor LE, Burris S. Syringeespr cription to prevent HIV infection in Rhode Island: a case study. Am J Public Health 2001;91(5):69-7 9 00.

24. Centers for Disease Control and Prevention. Fact sheet: physician escpr ription of sterile syringes to injection drug users. Atlanta, GA: Academy of Educational Development, 2002. Available at URL: http://www .cdc.gov/idu/facts/ physician.html.

25. Watters TK, Estilo MJ, Clark C, Lorvick JJ. Syringe and needle exchange as HIV/AIDS prevention for injection drug users. JAMA 1994;271:11520.

26. Bluthenthal RN, Kral AH, Erringer EA, Edlin BR. Use of an illegal syringe exchange and injection-related risk behaviors amongeestr t-recruited injection dr ug users in Oakland, California, 1992-1995. J Acquir Immune Defic Syndr Hum Retrovirol 1998; 18:50511.

27. Bluthenthal RN, Kral AH, Gee L, Erringer EA, Edlin BR. The effect of syringe exchange use on high-risk injection drug users: a cohort study. AIDS 2000; 14:605-11.

28. Normand J, Vlahov D, Moses LE, eds. Preventing HIV transmission: the role of sterile needles and bleach. Washington, DC: National Academy Press, 1995.

29. National Institutes of Health. Interventions to prevent HIV risk behaviors. NIH Consensus Statement 11-13 Febr uary 1997;15(2):1-41. Available at URL: http://odp.od.nih.gov/consensus/cons/10-i4n/1tro 04.htm.

30. Hagan H, Thiede H, Weiss NS, Hopkins SG, Duchin JS, Alexander ER. Sharing References of drug preparation equipment as a risk factor for hepatitis C. Am J Public Health 2001;91:42-6.

1. Edlin BF, Seal KH, Lorvick J, Kral AH, Ciccarone DH, Moore LD, Lo B. Is it jus- 31. Centers for Disease Control and Prevention. Fact sheet: physician prescription of tifiable to withhold treatment for hepatitis C from illicitdrug users? N EngI J Med sterile syringes to injection drug users. Atlanta, GA: Academy of Educational 2001;345:21-4 1.

Development, 2002. Available at URL: http://www .cdc.gov/idu/facts/a-iedu-dis.htm.

2. O’Connor PG, Selwyn PA, Schottenfeld RS. Medical care for injectiondrug users 32. Broers B, Morabia A, Hirschel B. A cohort study of drug users’ compliance with with human immunodeficiency virus infection. New Engl J Med 1994;331:4509. zidovudine treatment. Arch Intern Med 1994; 154:11217.

3. Weisner C, Mertens J, Parthasarathy S, Moore C, Lu Y. Integrating primary 33. Salomon N, Perlman DC, Rubenstein A, Mandelman D, McKinley FW, medical care with addiction treatment: a randomized controlled trial. JAMA Yancovitz SR. Implementation of universal directly observed therapy at a New ork Y 2001;286(14):171-2 53.

City hospital and evaluation of an out-patient directly observed therapy ogrpr am.

4. Batki SL, Sorensen JL. Care of injection drug users with HIV. In: Cohen PT, SandeInt J Tuberc Lung Dis 1997;1:397404.

MS, Volberd ing PA, eds. The AIDS knowledge base: a textbook on HIV disease om fr 34. Moatti JP, Carrieri MP, Spire B, Gastaut JA, Cassuto, JP, Moreau J. Adher ence the University of California, San Francisco and San Francisco General Hospital. to HAART in French HIV-infected injecting drug users: the contribution of 3rd ed. Philadelphia, PA: Lippincott, Williams and Wilkins, 1999. Available at bupre norphine drug maintenance treatment. AIDS 2000;14:1515.

URL: http://hivinsite.ucsf.edu/InSitejsp?page— kb-03&doc—kb-03-03-06.

35. Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, 5. Wartenberg AA. HIV disease in the intravenous drug user: role of the primary comper hension of the consent process, and retention of injection drug users ecruit-r care physician. J Gen Intern Med 1991;6(l suppl):S3540. ed for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum oRetr virol 1995; 6. Des Jarlais DC, Friedman SR, W ard TP. Harm reduction: a public health 10:3 86-90. response to the AIDS epidemic among injecting drug users. Annual Review of Public 36. Gourevitch MN, W asserman W, Panero MS, Selwyn PA. Successful adher ence Health 1993;14:41350. to observed prophylaxis and treatment of tuberculosis among drug users in a 7. Marlatt GA, ed. Harm reduction: Pragmatic strategies for managing high risk methadone program. J Addict Dis 1996; 15:93104. behaviors. New York: Guilford Press, 1998.

37. Marco A, Cayla JA, Serra M, et al. Predictors of adherence to tuberculosis eat-tr 8. Robertson R, ed. Management of drug users in the community: a practical hand-ment in a supervised therapy programme for prisoners before and after release. Eur book. London: Arnold, 1998.

Respir J 1998;12:96771.

9. Gostin L. Waging a war on drug users: an alternative public health vision. Law 38. Smirnof M, Goldberg R, Indyk L, Adler JJ. Directly observed therapy in an Med Health Care 1990;18(4):38594. inner city hospital. Int JuTberc; Lung Dis 1998;2:1349.

10. Sackett DL, Snow JC. The magnitude of compliance and noncompliance. In:39. Backmund M, Meyer K, Von Zielonka M, Eichenlaub D. Treatment of hepatitis Haynes RB, Taylor DW, Sackett DL, eds. Compliance in health care. Baltimor e: C infection in injection drug users. Hepatology 2001;34:18893.

Johns Hopkins University Press, 1979, p. 2112.

40. Sylvestre DL, Aron R, Greene DR, Perkins P. Treating hepatitis Cein corvering 11. Bangsberg DR, Moss A. When should we delay highly activeeantir troviral therinjection drug users (abstract #2886). Gastr oenterology 2001;120:A~68. apy? J Gen Intern Med 1999; 14:4468.

41. Dalgard O, Bjoro K, Hellurn K, et al. Treatment of chronic hepatitis iCnjin ec-t 12. Friedland GH, Williams A. Attaining higher goals in HIV treatment: the cen- ing drug users: 5 years’ follow-up. Eur Addict Res 2002;8:459. tral importance of adherence. AIDS 1999;13(Suppl 1):S6172.

42. Edlin BR. Hepatitis C prevention and treatment for substance users in the United 13. Panel on Clinical Practices for Treatment of HIV Infection. Adherence to potentStates: acknowledging the elephant in the living room. Int J Drug Policye(in ss).pr antiretroviral therapy. In: Guidelines for the Use of Antir etroviral Agents in 43. Gerlach et al. Acute hepatitis C: High rate of both spontaneous and eatmtrentHIV-Infected Adults and Adolescents. Rockville, MD: U.S. Department of Health induced viral clearance. Gastr oenterolog.y2003; 125(1):80-8.

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Alcohol and Hepatitis C

by Marion G. Peters, MD, MBBS, and Norah Terrault, MD

xcess alcohol consumption can worsen the course and outcome of chronic hepatitis C.1-3 However, adverse effects of moderate amounts of alcohol intake have not been clearly shown. 4 Alcohol use has been reported in some studies to be associated with higher HCV RNA levels and lower responses to therapy.5 Despite a large number of publications on the topic of alcohol and hepatitis C, current evidence from the literature is not adequate to provide clear and definitive recommendations regarding alcohol use in patients with hepatitis C. In the absence of conclusive data, a conservative approach is taken and abstinence is usually recommend6d.

E

Multiple studies have shown that heavy alcohol intake increases the risk of cirrhosis and liver cancer in hepatitis C.

What Level of Alcohol Intake Is Harmful in Chronic Hepatitis C? Poynard and coworkers compared liver histology of patients with hepatitis C drinking >50g. per day to that of non-drinkers and found a 34 percent increased rate of progression of fibrosis in heavy drinkers.1 Associations between fibrosis progression and lesser amounts of alcohol intake were not significant, but the measurement of alcohol intake was assessed in a uniform, standardized manner. The HCV National Register Steering Group in the U.K. traced 924 patients who had received an anti-HCV-positive unit of blood for an average of >10 years after transfusion and assessed alcohol intake using validated questionnaires.6 Liver-related deaths were increased among those who drank >20 units per week (approximately 30g. per day) in both patients with hepatitis C and controls. The Dionysos study analyzed hepatitis virus markers, alcohol intake (assessed by questionnaires of daily and lifetime intake), and clinical and biochemical evidence for liver disease among 6,917 unselected residents of two Northern Italian cities.3-7 In all, 2.3 percent had HCV RNA and 62 percent drank alcohol, including 21 percent who drank more than 30g. per day. Both control subjects and persons with HCV who drank more than 30g. per day for >10 years had a threefold higher risk of cirrhosis (95 percent CI = 1.2 to 7.4, p<0.01). Intake below 30g. per day did not increase the risk of clinically apparent cirrhosis, but histology was not assessed in most patients.

Harris and coworkers analyzed factors associated with cirrhosis among 206 patients who developed hepatitis C after transfusion and were followed for an average of 15 years in addition to a cohort of controls who were transfused but did not develop hepatitis C.8 Among those with hepatitis C, 17 percent developed cirrhosis. The risk of cirrhosis increased fourfold among those who were also heavy drinkers (>80g. per day). Corrao and Arico analyzed results from two hospital-based, case-control studies of 285 patients with cirrhosis and 417 controls.4 A lifetime daily alcohol intake of >50g. per day was associated with an increased risk of cirrhosis in both HCV-positive and negative subjects. The combination had an additive effect on the risk, and these risks were multiplied

(synergism) at very high levels of alcohol intake (>125g. per day). Wiley and coworkers analyzed factors associated with more advanced liver disease in a cohort of 176 patients who underwent liver biopsy for chronic hepatitis C.2 Alcohol intake of > 80g. daily was associated with a higher rate of cirrhosis (56 percent vs. 22 percent) and an increase in the estimated rate of progression of fibrosis. In a study from Japan, Khan and Yatsuhashi found higher degrees of fibrosis on liver biopsies from patients with chronic hepatitis C who drank alcohol compared to those who did not, and this increase was seen with both heavy (>80g. per day) and â&#x20AC;&#x153;moderateâ&#x20AC;? (<80g. per day) alcohol intake.9 Further delineation of effects of lower levels of alcohol intake were not given. Excess alcohol intake can also predispose to the development of liver cancer.10 Thus, multiple studies have shown that heavy alcohol intake increases the risk of cirrhosis and liver cancer in hepatitis C, but the effects of moderate alcohol intake have not been adequately evaluated.

Are There Gender Differences in Effect of Alcohol on Progression of HCV Infection?

Chronic hepatitis C is often milder in women, but women may be more sensitive to the adverse effects of alcohol. The Dionysos cohort study found the risk of cirrhosis was twice as high in women as in men with the same alcohol intake.3,7 Wiley et al. found a lower alcohol threshold for development of cirrhosis in women.2 Thus, women may be at increased risk of alcohol effects on chronic hepatitis C. What Are the Effects of Alcohol Consumption on Treatment of Hepatitis C? Alcohol can affect the outcome of therapy in decreasing adherence or interfering with the antiviral actions of interferon or combination therapy. Virtually all large trials of therapy of hepatitis C have excluded persons who have a recent history of alcohol abuse, requiring a one- to two-year period of abstinence before therapy is initiated. However, the need for a period of abstinence has never been shown. Among patients treated for hepatitis C, a proportion continued drinking, and the ultimate response rate correlated inversely

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with the level of alcohol intake during therapy. The mechanism of the decreased response rate in patients drinking alcohol has not been defined. Some studies have shown that alcohol intake is associated with higher levels of HCV RNA,1,5 but other studies have not,2,3,10 and the increase in HCV RNA levels with drinking alcohol has been modest. Thus, continued alcohol intake during therapy is likely to adversely affect the response to treatment, and both counseling and monitoring before and during therapy is recommended.

Managing HCV among IDUs Overcoming the Politics of Exclusion

by Allan Clear

Reprinted fromHarm Reduction Communication, Summer, 2002

Does Alpha Interferon Therapy Cause an Increase in the Rate of Relapse Among Persons With a History of Alcohol Abuse or Dependence?

Relapse in alcohol intake during alpha interferon therapy has been reported, but the rate of relapse has not been compared in studies using untreated control patients. Nevertheless, the depression, irritability, and anxiety that occurs in 20-30 percent of patients treated with alpha interferon is likely to be difficult for the patient with a recent history of alcohol dependence and predisposition to relapse.

S

INCE THE LATE 1970s, THE U.S. HAS pursued a national policy of deterrence to make drug use as risky and as unpalatable for individuals as possible. Hence, paraphernalia laws were enacted to make purchase and possession of syringes a crime, often making the securing of sterile injection equipment impossible. At the same time, prison sentences were heightened and strictly enforced based on the mistaken belief that this threat would force drug users to cease their drug use. The unintended but, for policy makers, not necessarily regretted consequence of the Conclusions war on drug users is that we now have several overlapping, While the effects of heavy daily alcohol intake on the course concurrent epidemics that have devastated the drug-using of chronic hepatitis C appear to be incontrovertible, lesser community, including HIV, HCV, incarceration and overamounts of alcohol may not be harmful. On the other hand, dose. abstinence appears to be prudent for the patient with chronWomen, African-Americans, gay men and lesbians have all ic hepatitis C, particularly while receiving a course of alpha made great strides in achieving civil rights and human diginterferon or combination therapy. Patients with a history of nities, strides which so far have eluded drug users. However, alcohol abuse or dependence should be asked to be abstinent despite stigmatization and the social isolation imposed upon for a period before starting therapy and need to be supportthem, drug users are capable of both self-care and self-advoed by professional counseling and monitoring during theracacy. Since the emergence of the HIV epidemic in the mid py. Better studies using validated instruments to measure 1980s, drug injectors have made substantial changes in the alcohol intake in larger numbers of patients, followed for way they use drugs. As awareness of how HIV was being longer periods and with careful histological documentation, transmitted grew and as they witnessed their friends rapidare needed to better define the effects of moderate alcohol ly die off, drug users took steps to reduce syringe sharing. intake on chronic hepatitis C and the need for abstinence Contrary to popular belief, drug users are capable of before and during therapy. At the present time, there is no addressing their own health needs, especially when obstareason to withhold antiviral therapy of chronic hepatitis C cles induced by the drug war are eliminated. from the patient with a history of alcoholism as long as adeLittle attention has thus far been given to specifically quate support can be provided during the period of therapy. addressing HCV among drug users. To date, it is not possible to point to a single intervention that is a perfect or even References satisfactory prevention strategy. We need to launch a public 1. Poynard T, Bedossa P, Opolon P, for the OBSVIRC, MEETAVK CLINVIR, and education campaign that utilizes a comprehensive, realityDOSVIRC groups. Lancet 1997;349:82532. based approach that will affect drug using behaviors and 2. Wiley TE, McCarthy M, Breidi L, Layden TJ. Impact of alcohol on the histolog-norms. ical and clinical progression of hepatitis C infection. Hepatology 1998;28:8059.

3. Bellentani S, Pozzato G, Saccoccio G, Crovatto M, Croce LS, Mazzoran L, et al. Preventing Transition Clinical course and risk factors of hepatitis C virus related liver disease in the gen-One way of lowering transmission is to reduce the number eral population: erport from the Dionysos study. Gut 1999;44:87480. of people who transition to injection drug use. If individu4. Corrao G, Arico S. Independent and combined action of hepatitis C virus infec-als choose to use drugs, they should be receiving accurate information and strategies that support a healthy relationtion and alcohol consumption on the risk of symptomatic liver cirrhosis. Hepatology 1998;27:91-49. ship to their drug use. Education aimed at novice and young 5. Loguercio C, Di Pierro M, Di Marino MP, Federico A, Disalvo D, Crafa E, et al. drug users, as well as those who are contemplating drug use, Drinking habits of subjects with hepatitis Cuvir s-related chronic liver disease: should cover two main areas: strategies for controlled use prevalence and effect on clinical, virological and pathological aspects. Alcoholand realistic information about the increased risks associatAlcohol 2000;35:296301. ed with injecting. Individuals transition to injection drug

use for a number of reasons, including economic and peer pressures. Controlled use can be established by creating a consciousness around individual drug patterns, an invest7. Bellentani S, Saccoccio G, Costa G, Tiribelli C, Manenti F, Sodde M, et al.

Drinking habits as cofactors of risk for alcohol induced liver damage. The Dionysosment in social networksâ&#x20AC;&#x201D;including family, friends and Study Group. Gut 1997;41:84550. workâ&#x20AC;&#x201D;and the sustained pleasure associated with drug taking. There is very little recognition given to the notion that 8. Harris DP, Gonin R, Alter HJ, Wright EC, Buskell ZJ, Hollinger FB, et al. The relationship of acute transfusion-associated hepatitis to the development hofo-cirr drugs do fulfill a viable function for people. They provide sis in the presence of alcohol abuse. Ann Intern Med 200 1; 134:1204. pleasure, relaxation, relief of physical and psychological 6. Harris HE, Ramsay ME, Andrews N, Eldridge KP. Clinical course of hepatitis C virus during the first decade of infection: cohort study. BMJ 2002;324:16.

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pain, diminish awkwardness in social situations and have been consumed throughout the recorded histories of all civilizations. Individuals should have a right to explore the limits of their own consciousness, and also should have a right to expect that society will not deny them stability and civil resources.

A successful public education campaign to address the dangers of injection drug use can’t focus on any single risk but must encompass a range of issues, including—but not limited to—HCV, HBV, HIV, soft tissue infections, endocarditis, tetanus and wound botulism, overdose and the consequences of the stigmatization of drug use. Similarly, providing a range of options within such a campaign is crucial. Working out a systematic plan for taking drug breaks is a strategy for identifying drug use that‘s for pleasure and use that’s by necessity. A positive relationship with drugs can be maintained more easily if drug use does not become the central defining factor in a person’s life. Taking periods of time away from use is one way of maintaining a healthy relationship to one’s drug of choice. “Less is more” is an adage that can be applied here.

The less frequently one uses drugs, the longer the pleasure from that drug use can be sustained. Unfortunately, individuals (especially young people) are often faced with the blank dichotomy of either remaining in the “straight world” or delving deeper into a drug- using sub culture.

One of the major co-factors for risky drug behavior is a history of childhood trauma, especially sexual abuse. Sustained public education and interventions to eliminate childhood abuse are essential not just for ameliorating unhealthy drug and alcohol problems but to improve the general health and safety of our communities.

New Injectors Without question, some people will inevitably begin to inject drugs. Some will use only once or twice, others will use periodically and a small proportion will use over long, sustained periods of their lives. Early studies forecast a bleak prognosis of a brief, 1-year period from onset of injection to HCV infection.1 However, more recent studies support increased optimism and reveal a much longer window of opportunity.2 Until now, messages developed as HIV prevention strategies have dealt with the end point of injection, namely syringe use. As drug users, advocates, educators and scientists have developed greater awareness of HCV, we’ve started talking about not sharing cookers and cottons. This education is woefully insufficient. Essentially we’re rolling a film backwards, starting at the end. Injection is a process and a skill to be developed and we need to talk about the process from even before the moment drugs are obtained.

Throughout the 1990s, drug users aware of their positive HIV status have played a major role in reducing the HIV epidemic in New York City by not sharing equipment. However, altruism alone cannot be expected to be the answer. Drug users need concrete and widely accepted support for their efforts.

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It is immoral, unethical and uncivilized to deny treatment to an individual based solely on their drug use.

Planning cannot be under emphasized. Good injection technique needs to be taught and encouraged. A sterile injection environment may be an unlikely scenario for many but promoting hygiene should be a norm. It starts with washing hands and arms, and includes clearing a personal space, seeking out clean surfaces or spreading out a sheet of newspaper, another similar surface or a boundary marker (only clean equipment—not contaminated by exposure to blood—should pass that boundary into the clean field).

People have recognized that as injecting sessions progress it may be easy to lose track of what’s what, so promoting the individual marking of syringes can be helpful, while having a copious supply of sterile syringes on hand is preferable.

The division of drugs between users is possibly the point at which the majority of infections occur. Splitting drugs is often an economic necessity. However, it can be accomplished without contaminating the cooker by using a new syringe and clean water to divide the drugs. If necessary, or if in doubt, the cooker can be cleaned, or, better yet, replaced with a fresh one.

(Just as with syringe cleaning, disinfecting a cooker requires care and time.) Next, the injection site should be cleaned with soap and water or with an alcohol pad. After injection, gentle pressure can be applied to the injection site using tissue, or cotton, to stop bleeding. (Alcohol pads don’t work because the alcohol stops blood from clotting.) People can be guided to disposing used tissue or cotton in the trash, and used syringes in a puncture proof container or sharps box. To finish, people can be encouraged to wash their arms and hands again, and rewipe the injection preparation surface. People should consistently be aware of where contamination may have occurred, and take care of it before they forget.

The drug-using community has adjusted drug-using norms before to fight HIV; it will do so again to combat the additional challenges of HCV! Older Injectors Any public education campaign must also target more experienced injectors. A new injector is at higher risk of contracting HCV if initiated into injection by someone who has been using for longer than five years.3 Yet epidemics such as HIV and HCV are reduced by efforts of seropositives to stop transmitting the infection. There has been an on-going public education and awareness campaign about HIV, and drug users have long been aware of the risks they undertake when injecting (even though they frequently have no control over the environment causing their risk.) Throughout the 1990s, drug users aware of their positive HIV status have played a major role in reducing the HIV epidemic in New York City by not sharing equipment. Appealing to the altruistic nature of informed and empowered users can similarly reduce HCV. Needless to say, altruism alone cannot be expected to be the answer. Drug users need concrete and widely accepted support for their efforts. Widespread screening to establish awareness of HCV status—accompanied by education,

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vaccinations against HAV and HBV and other resources such as referrals to other medical and social services and access to injection equipment—will all have an impact of the future of the epidemic.

Sterile Syringes and Safe Injection Spaces Syringe programs have been enormously important in controlling HIV among injectors. Countries and communities that commenced syringe exchange programs when HIV infections were minimal, such as in Australia and Tacoma, Washington, have kept infection rates low. Recent data from New York City and New Haven indicate that an epidemic situation can be brought under control through syringe exchange.4 HCV screening data from Users Unite! The Hepatitis Project at the Lower East Side Harm Reduction Center in New York City indicates that 50% of tested program participants have positive results. This is significantly lower than rates of 80% among injectors in other communities who do not have long term and easy access to syringes.

Similarly, newer injectors in Glasgow and Edinburgh have shown dramatic decreases in HCV infection due in part to regularly accessing syringe exchange programs. Although we are a long way from acceptable levels of HCV within the drug-using community (is there an acceptable level?), we are now seeing that the size of the HCV reservoir can be reduced.

Until now, safe injection spaces have not been considered as a mechanism for preventing viral transmissions, although a small data set from Switzerland is encouraging. Safe injection rooms have been primarily useful as a response to eliminating public injection and reducing overdose fatalities.

However, along with syringe access programs they could provide an opportunity to establish standards for hygienic injection practices and for affecting community norms.

Treatment The medical community has been reluctant to treat HCV in active drug users, principally based on fears of treatment non-compliance and HCV reinfection during and post treatment. Drug users are also reluctant to investigate treatment and frequently have negative attitudes towards interferonbased therapies. As educated consumers they are aware of side effects, longevity of treatment and low success rates.

Through experience, they are also wary of attempting to access a hostile medical system. However, it is immoral, unethical and uncivilized to deny treatment to an individual based solely on their drug use. Treatment decisions must be made on an individual case-by-case basis. Drug users can present with multiple problems, including unstable living situations, histories of depression and other mental illnesses and complicated medical conditions, all compelling reasons for both parties not to choose treatment. However, individuals who have contracted HCV through transfusion may also have multiple health complications, but these patients are not systematically rejected for treatment.

Although not uniformly, doctors have learned to successfully work with drug users in the treatment of HIV. At the recent HCV consensus conference in France the medical community responded to the question of treating drug users with, “These patients should be taken in charge by a multidisciplinary team before starting treatment, in order to evaluate their psychological, relational and social stability (often favored by replacement therapy), their need for psychological support, their use of psychotropic drugs and to provide them and their friends/family with adequate information.

Occasional drug use by an otherwise stabilized patient does not contraindicate treatment.”5 There are many individuals with a history of drug use who are capable of assessing the pros and cons of treatment and with whom a comprehensive treatment plan can be devised.

And their treatment course and outcomes will be no better, nor worse, than anyone else’s.

What we don’t know is how medical treatment environments affect outcomes. Considering who is infected with HCV it would seem to make sense that medical care and treatment should be provided to drug users in a culturally appropriate and sensitive setting. Methadone programs have long established on-site primary care clinics and syringe access programs could also provide the same level of care.

There are clinics that specifically address the health needs of women, gay/lesbian/transgendered people and other communities, so why not health clinics for drug users? Although Users Unite! The Hepatitis Pr ojectshows the viability of HCV screening, participants are usually reluctant to get confirmatory tests. This lack of continuity of care is a considerable barrier to improved health outcomes. Successful treatment of drug users will decrease the population burden of HCV and lower the incidence of new infections.

Alcohol Excessive alcohol consumption, defined as 4 or more drinks a day, is perhaps the single greatest factor in determining progression to cirrhosis, liver cancer and end stage liver disease, yet alcohol is not addressed in any significant fashion by syringe exchange programs. Health messages regarding the use of alcohol have been mixed. Methadone programs inadvertently promote alcohol use among their patients by testing urine for both secondary drug use and alcohol but more stringently punishing the drug use. Even advocates who are tolerant of drug use put out the message that alcohol will lead to death, so stop! Maybe this is in a state of change, as New York City’s Positive Health Project has taken pro-active steps to address alcohol use as a health problem among its participants by applying for an alcohol treatment license. More information is needed so that drug users who drink can receive credible information. We need to know how much alcohol is tolerable for someone living with HCV. We don’t know if consistent moderate alcohol use is better than occasional binge use and we don’t know about occasional social use.

Similarly we don’t know enough about drug use, how routes of administration may affect disease progression and whether drugs themselves, or the various substances found in them, may accelerate liver disease. What impact does drug quantity, quality, frequency and type have on the liver?

What about the combination of street drugs and alcohol?

Does it make a difference if one smokes, snorts, ingests or injects once one has HCV? Is a nicotine patch preferable to smoking cigarettes? Is cocaine actually helpful in promoting natural interferon? What difference do varying forms of cut make? We need to undertake a research agenda that is specifically directed to answering questions pertaining to drug use and drug users.

Conclusion Drug users are a heterogeneous group. Within all populations, but particularly vulnerable populations, power and control cannot be underestimated as co-factors in disease transmission. Street-based youth and women can be particularly vulnerable to lack of control over their environment.

For prisoners, this goes without saying. Within the prosecution of the war on drug users, class and race are also enormously important in assessing situations of risk. The more intense the drug repression against the poor and against communities of color, the greater the level of risk people face. The ultimate goal of any campaign is to eliminate all viral infections, but with HCV an important step toward eliminating new infections is to bring prevalence down to a manageable level. This can be done by reducing transmission, improving treatment access and promoting better healthcare. However, this cannot be achieved effectively without preventing the discrimination, stigmatization and isolation of drug users. It won’t be public health institutions eliminating this epidemic. It will be drug users themselves.

Allan Clear is HRC’s Executive Director .

1. Garfein RS, Vlahov D, Galai N, Doherty MC, Nelson KE. Viral infections in short-term injection drug users: the prevalence of the hepatitis C, hepatitis B, human immunodeficiency, and human -lyTmphotopic r viruses. Am J Public Health.

1996 May;86(5):655-61.

2. Hagan, H., Thiede, H., & Des Jarlais, D. C. (2003). Survival analysis of time to HCV seroconversion in a cohort of Seattle IDUs. In esspr , Epidemiolog. y 3. Alex Kral, personal communication.

4. Noga Shalev, personal communication.

5. Consensus Conference on Treatment of Hepatitis C, u Febr ary 27 & 28, Maison de la Chimie, Paris, France. A similar tack was taken at the 2002 NIH HCV Consensus Development Conference. A draft of the new Consensus Statement says, "All patients with chronic hepatitis C are potential candidates for antiviral therapy ."

HARM REDUCTION COALITION POLICY STATEMENT ON HEPATITIS C The Hepatitis C virus (HCV) is inordinately affecting injection drug users nationally and globally. As with HIV, injection drug users experience hepatitis C progression that is facilitated by stigma, criminalization and denial of basic human rights. Drug users are refused access to prevention materials and denied treatment when infected. Symptoms are often overlooked or dismissed by providers as the effects of illicit drug use.

The Harm Reduction Coalition is demanding the following standards with regard to HCV and drug users: • Full pre- and post-education and support must accompany all screening for HCV. • At-risk individuals who present possible symptoms of HCV infection must be advised of the availability of counseling, education and screening as a standard of care.

• HCV testing cannot be mandatory.

• Routine testing should be accompanied by comprehensive education following the patient’s consent. Such education should include information on transmission and prevention; the meaning of the various diagnostic tests; outcome of HCV; eligibility for and o utcomes of currently available treatments.

• All counseling provides safer injection education.

• Drug users cannot be restricted from appropriate treatment based solely on their drug use. Drug users must be offered treatment just like any other HCV+ patient.

• All infected individuals should be provided with vaccinations for Hepatitis A and also Hepatitis B when appropriate.

• HCV screening must be freely available to all injectors and cannot be limited to institutional contact points such as drug treatment or jail .

• New and young injectors, particularly higher risk youth, must be a focus of education.

• Clinical trials must not exclude drug users.

• Research on transmission of HCV among drug users must be intensified.

• Individuals on drug maintenance therapies, such as methadone, cannot be restricted from accessing care, clinical trials or treatment—including transplants.

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Dealing With Hepatitis Some Facts for Injectors Reprinted fromHarm Reduction Communication, Spring, 1998

Some General Signs and Symptoms of Active Hepatitis Infection The most common symptoms are fatigue, mild fever, muscle or joint aches, nausea, vomiting, loss of appetite, mild abdominal pain, and sometimes diar rhea. Although not as common, some people notice dark urine and light colored stools, followed by jaundice in which the skin and/or the whites of the eyes appear yellow. Some people who are infected with hepatitis lose their taste for cigarettes. Many cases go undiagnosed because symptoms are mild or suggest only a flu-like illness. Sometimes people have no symptoms at all.

How to Avoid Getting hepatitis A, B and C Hepatitis A, B and C are preventable diseases.

You can prevent hepatitis A by: • getting vaccinated • washing your hands thoroughly after using the bathroom • being as careful as possible to eat food prepared under sanitary conditions • using fresh, clean water that is not shared to inject (if you use water from a toilet, take from the tank, not the bowl) • using a barrier for oral/anal sex You can prevent hepatitis B by: • getting vaccinated • using a sterile syringe/new cotton/clean, fresh water • using clean injection equipment (see section on bleach) • having protected sex You can prevent hepatitis C by: • using a sterile syringe/new cotton/clean, fresh water • using clean injection equipment (see section on bleach)

About Bleach Bleaching your rigs and equipment is effective against killing the hepatitis B virus, but only if the bleach is in contact with the syringe for at least 2 minutes. This is different from the usual recommendations for cleaning with bleach to kill HIV. The hepatitis virus is hardier than HIV and is harder to destroy.

Bleaching for at least 2 minutes is probably necessary in order to kill the hepatitis C virus, but studies have not yet been done to prove this.

Cleaning and rinsing with cold water is also helpful: at least 2 washes + 2 bleaches + 2 rinses (use separate water for washing and rinsing!).

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What Is the Hepatitis Vaccine?

Hepatitis A and B can be completely prevented by getting vaccinated. Currently, there is no vaccine for hepatitis C. Hepatitis A vaccine consists of two shots over the course of 6 months.

Hepatitis B vaccine consists of 3 shots over the course of 5-6 months.

There is also a combined hepatitis A and B vaccine: 3 shots over the course of 6 months.

For complete protection (immunity) against hepatitis A or B, you must get all of the shots in each series.

While no vaccine is 100% safe, there have been very few side effects with the hepatitis A and B vaccines.

Where Can You Get hepatitis A and B Vaccines?

Whether you have a regular provider or not, be confident in asking for the hepatitis A and/or B vaccines (you may want to bring this brochure with you). Some clinics will offer the vaccines only if you are a certain age, or only if you ask, and others will vaccinate you only if you are a regular patient.

For more information about hepatitis, call the American Liver Foundation National Hepatitis Hotline: 1-888 4HEP ABC (1-888-443-7222) This information is adapted from a leaflet provided by University of California, San Francisco (UCSF) Department of Epidemiology and Biostatistics San Francisco General Hospital 995 Potrero Avenue, Bldg. 90, Ward 95 San Francisco, CA 94110

Taking Care of Your Liver: Treatment and Nutrition Hepatitis C Drug Therapy for People on Methadone Maintenance

by Matthew Dolan Originally appeared in Spring 2001 User’s Voice. Reprinted from

Harm Reduction Communication, Summer, 2002

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he subject of treating hepatitis C positive (HCV+) opiate-injectors users with interferon-based therapy has been shot through with controversy (no pun intended). I recently attended the Hepatitis C Global Foundation Conference in San Francisco (Ed note: Matt’s referring to the July, 2000 event), where I was able to interview doctors treating these groups.

Barry Clements, P.A.C., and Diana Sylvestre, M.D., work at OASIS (Organization to Achieve Solutions in Substance Abuse), a nonprofit medical clinic in Oakland, California.

They provide medical treatment to hundreds of people living with hepatitis C (and sometimes HIV, too) most of whom are methadone patients, or in a few cases, active drug users. In general OASIS’ clients are economically disadvantaged, have ongoing chemical dependency issues and a substantial number have mental health problems. OASIS also provides counselling and facilitates peer support groups, which have played a key role in advocating and managing drug therapy for maintenance clients.

“Our clients who have been through therapy are the best advocates for this treatment; on-going support is critical to the success of our programme,” observes Dr. Sylvestre.

There is no pressure on people attending the clinic to take the therapy. Those who express an interest are carefully screened for both suitability and the likelihood of being able to comply.

Suitable candidates must show evidence of the presence of HCV RNA in the blood, as well as liver disease progression, two widely accepted indicators of a need for this imperfect therapy. Clients are counselled regarding the implications of HCV, including making the point that debilitation is more likely than death.

The first step is to confirm the presence of hepatitis C using ELISA antibody tests for HCV. If the test comes back positive OASIS uses the PCR test to confirm the presence of virus particles in the blood. To date OASIS has found that 23% of their clients who are antibody positive are PCR negative, a higher than average figure. It is speculated that this MIGHT have something to do with the immune systems of IDUs being on “red alert,” possibly relating to the large num-

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ber of impurities in street drugs. Genotype tests are also ordered, because this has a big bearing on the likelihood of response to HCV treatment.

Sylvestre notes a high incidence of autoimmune conditions among her patients, particularly type II diabetes. It is not clear to what extent these are due to HCV, or lifestyle.

Tests for hypertension, blood cholesterol, anaemia and arthritis are ordered. They are also screened for other comorbid or complicating conditions such as HIV, TB, hepatitis A and B and syphilis, as well as for psychiatric disorders and signs of using street drugs.

A full panel of blood tests for liver function are ordered for candidates: these include ALT/AST, bilirubin, albumin, GGT, AFP, platelets and prothrombin time. Liver biopsy is the preferred method of confirming levels of both structural damage and inflammation in the liver. Sylvestre and Clements are keenly aware that normal ALTs are poor absolute indicators of liver damage in HCV patients, and that AST levels can correspond to organs other than the liver. Twenty-two percent of their patients with advanced fibrosis have normal AST/ALT results; a peculiarity they attribute to liver damage caused by long term HCV infection (damaged livers often produce fewer liver enzymes). Biopsy candidates are supported by other patients who have been through the process—many clients find this particularly daunting. The biopsy is not compulsory, nor a condition of treatment.

Before being started on treatment, patients must show their commitment by regularly attending the educational sessions. Requirements for active users: they must want and need treatment (histologic need or showing severe symptoms), have no medical contraindications and be able and willing to reliably come to appointments. Treatment currently consists of pegylated interferon plus ribavirin. (Ed note: the results reported below are for standard interferon/ribavirin, as the pegylated version had not been released at the time treatment was conducted.) They have found that pegylated interferons, only needing to be injected once per week, have greatly assisted compliance, but have certainly not neutralised side effects, as is sometimes claimed by those close to

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the pharmaceutical companies manufacturing these drugs.

“This is a heavy treatment, particularly if folk are having a rough time already; this can push them over the edge….We need to see these patients frequently. People have died on this,” comments Sylvestre.

Once the patient has started, OASIS’ approach is to go to great lengths to support them with medication. It is not uncommon to prescribe patients Procrit (a bone marrow treatment supporting red blood cell production), antidepressants, and anti-inflammatory drugs. About 24% drop out. Of those who stay the course 88% are on anti-depressants by the end of therapy.

The staff are very proud of their results. 54% of methadone patients are free of detectable virus at the end of therapy,1 which is in line with other published results in the U.S. Sylvestre is also keen to stress what she sees as the qualitative, social benefits of the programme, which, she emphasizes, is dependent upon group support and close, frequent monitoring: “The treatment can be a bridge to a sober life; we have seen some remarkable stories.”

Treatment of HCV in the Methadone Patient

by Diana L. Sylvestre, MD Reprinted from HCV Advocate’s Medical Writers’ Circle, a publication of the Hepatitis C Support Project. Visit their web site at http://www.hcvadvocate.org.

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njection drug users (IDUs) have the highest HCV infection rates of any behavioral risk group, and in the US, injection drug use accounts for at least 60% of new cases.1 Approximately 70-96% of long-term injection drug users are infected with the virus. 1-6 Parenteral transmission is very efficient: as many as 65%-70% of IDUs are infected within one year of needle use, and after 5 years of injecting, 4, 5, 7-9 For this Matt Dolan is the author of The Hepatitis C Handbook – Revised Edition. Editedas many as 90% of users are infected with HCV.

by Iain M Murray-Lyon MD. CALL 020 8986 4854 ISBN is 0 9529509 2 8. reason, many experts estimate the length of exposure to HCV Email mo@centralbooks.com for further enquiries and orderingm infor ation. in drug users by subtracting one year from the total number of lifetime years of needle use.

For additional information about O.A.S.I.S, see Despite the remarkably high prevalence of HCV in IDUs, http://www.oasisclinic.org. there is surprisingly little data about treatment in this population. Comorbid psychiatric disease,10-12 relapse to substance Postscipt (January, 2002): use,13,14 reinfection15-17 and poor adherence18,19 are potential obstacles that must be addressed when treating IDUs for I recently spoke to Diana Sylvestre to see how the OASIS HCV. However, severe interferon-mediated depression does program was progressing. She explained that the results Matt not necessarily correlate with preexisting psychiatric disreported in his earlier article were from OASIS’ patients who ease,20-22 and human data on HCV reinfection after treatment had been receiving the standard interferon/ribavirin combiis extraordinarily scant. 14,23 Studies to date have not shown a nation treatment on an outpatient basis. Some of them were substantial impact of substance abuse relapse on treatment formally enrolled in a study (study requirements: active disoutcomes in IDUs,14, 23 and careful adherence data is lacking. ease-demonstrated histologic need or presence of severe side In light of the overwhelming prevalence of HCV in IDUs,3,8 effects, no unstable medical or psychiatric conditions, willthe increasing morbidity of this disease,2 and the limited ingness to undergo treatment, at least 6 months of abstinence access of IDUs to liver transplantation,24 it is imperative to from alcohol and/or illicit drugs prior to onset of drug therdevelop treatment approaches for IDUs that realistically apy); others were treated in parallel by OASIS, with the same assess and surmount these barriers. An approach that focusless rigid requirements for treatment as reported on the prees on more stable recovering IDUs provides an ideal ceding page (patients must want and need treatment, have opportunity to understand the impact of treating this relano medical contraindications and be able to come to tively difficult population with medications that may appointments reliably). A new study protocol is in the works, potentially be problematic. using pegylated interferon/ribavirin, with half of the 200 Methadone maintenance is currently the most effective patients receiving standard outpatient therapy and the other pharmacologic treatment for chronic heroin addiction.25-27 A half undergoing directly observed therapy (DOT, where the synthetic narcotic with actions similar to morphine and heropatient takes the medication in the presence of a health care in, methadone has a half-life of 15-25 hours and can be provider). In the new study, the formal criteria remain the dispensed as a treatment for heroin addiction only by hospisame as above, but OASIS has the option of admitting tal pharmacies and by federally regulated drug treatment patients with three to six months of abstinence if they meet programs.25 The methadone withdrawal syndrome is qualitaall of the other study requirements. Patients in the formal tively similar to that of heroin, but it differs in that the onset study receive free medication. Patients not on the study who is slower, the course is more prolonged, and the symptoms cannot afford treatment will not be turned away. (Note: there are less severe. It is used most effectively as a long-term are some patients with medical insurance who pay for their maintenance treatment with ancillary psychosocial intervenoffice visits and lab tests.) tions.28 Used appropriately, methadone has been shown to One additional finding of interest that Matt doesn’t mendramatically reduce recidivism and assist the majority of tion: OASIS’ methadone-using patients raised their doses by a those taking it with achieving medical, psychological, and median of 10mg over the course of their treatment. For a full psychosocial stability.25 report on OASIS HCV treatment program, see the accompaO.A.S.I.S. (Organization to Achieve Solutions in nying article, “Treatment of HCV in the Methadone Patient.”

Substance-Abuse) is a nonprofit organization located in 1 Note that these are end of treatment results, not sustained viral response (SVR)Oakland, CA that provides medical treatment to recovering rates. See the accompanying article “Treatment of HCV in the Methadone Patient” IDUs, with a focus on developing HCV treatment strategies for the OASIS patients’ SVRs. in this population. Nearly 1,000 IDUs have been screened for

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HCV and approximately 100 methadone patients have been treated for the disease.29 Its group treatment model is to date the most effective means of treating HCV in IDUs.30,31 Current research is focusing on HCV treatment in methadone patients and understanding the impact of psychiatric disease, length of sobriety, and intervening drug and alcohol use during HCV therapy in this population.31 Compared to HCV patients in large worldwide studies of HCV therapy, O.A.S.I.S. methadone patients are older, more racially and sexually balanced, and are therefore more representative of HCV-infected persons in the U.S. The median length of HCV infection is over a decade longer than that seen in most studies, and a history of heavy alcohol use is common. The majority of patients report a previous diagnosis of psychiatric illness. Seventy-seven percent of patients exhibit current infection as determined by PCR. In concert with the relatively lengthy exposure to the HCV virus and frequent history of comorbid alcoholism, methadone patients show substantially more advanced liver fibrosis, or scar tissue, as compared with typical nondependent populations. Fibrosis on liver biopsies is typically graded on a scale of 0-4, with 0 being no fibrosis and 4 being severe fibrosis, or cirrhosis. The average fibrosis stage in O.A.S.I.S. methadone patients is 2.6, much higher than the scores of approximately 1.2-1.4 seen in typical treatment populations. Advanced fibrosis of stage 3 or higher was seen in 29% of O.A.S.I.S. patients, and fewer than 20% had minimal liver disease. Of those with elevated liver enzymes on blood testing, 37% showed advanced fibrosis of stage 3 or higher, and surprisingly, up to 22% of those whose liver enzyme tests remained persistently normal showed advanced fibrosis. It is obviously of great importance in these patients to proceed with a full workup, even in the presence of blood tests that many would consider reassuring.

Treatment results of the first 59 methadone patients (of 105 projected) to complete standard interferon/ribavirin combination therapy using the O.A.S.I.S. group model show a sustained response rate (SVR) of 28%, modestly lower than the 41% SVR seen in large trials of non-dependent populations. The overall dropout rate for this population is 24%, similar to the 20-21% dropout rate typically seen in HCV treatment trials. These results raise a question: what is it about the methadone patients undergoing treatment in this trial that led to a reduced treatment response? How does psychiatric disease, sobriety length, and drug or alcohol use during treatment influence response rates? Is the use of methadone while on HCV treatment problematic, and therefore should methadone patients undergo detoxification prior to HCV treatment?

Patients reporting a pre-treatment psychiatric diagnosis showed a lower SVR when compared with non-psychiatric patients, 22% vs 37%. Overall, 50% of patients in the study were taking antidepressants prior to therapy and 88% were taking such medications by treatment completion, with SSRIs like citalopram (Celexa) and paroxitene (Paxil) being the category of medications most commonly prescribed. These results suggest that prophylactic antidepressants might need to be considered in the majority of such patients contemplating treatment.

Overall, 21% of treated patients consumed alcohol of some quantity during HCV

therapy, but the patients who consumed alcohol had only a mildly reduced SVR, 25% vs 29%. Because of the low number of patients in the alcohol group, a subanalysis of the effect of larger vs. smaller quantities of alcohol could not be undertaken.

An analysis of the impact of sobriety length on treatment outcomes showed that being sober at the start of treatment was important, even if that period was relatively short.

Patients with sobriety lengths of less than six months exhibited virologic responses similar to those with more lengthy sobriety, 37% vs. 30%, respectively. However, patients without pretreatment drug sobriety showed a decrement in treatment outcome, with an overall SVR of 17%.

Thirty-five percent of study patients used heroin, cocaine, and/or methamphetamines during HCV treatment. Those using these drugs showed an SVR of 20%, compared with 32% in abstinent patients. When analyzed by quantity of drug use, a stepwise decrement in treatment outcome was seen, with the most dramatic effect of this behavior seen in those using drugs regularly. None of these patients showed a virologic response, whereas 20% to 29% of those using drugs less frequently showed a sustained virologic response.

Because a substantial proportion of patients using drugs infrequently showed acceptable virologic outcomes, relapse to drug use during HCV treatment should not prompt HCV treatment discontinuation, but rather an early and aggressive attempt to intervene before the drug use becomes regular.

Putting it all together, methadone patients undergoing HCV therapy have a host of potentially difficult barriers to treatment, including underlying psychiatric illness, alcohol use, and drug use. When treated patients without any of these characteristics are analyzed separately, their SVR is 50%, even higher than that of the published trials. Clearly, methadone use during HCV treatment is not problematic, and may indeed be protective of response rates by assisting with adherence to HCV therapy and maintaining medical stability.

These results suggest that a decision to treat HCV should not be negatively influenced by methadone therapy, and that, while substance use is associated with reduced treatment responses, a significant proportion of patients still benefit. In light of these findings, although we emphasize helping our patients avoid any substance abuse, a strategy that focuses on aggressive psychiatric intervention, side effect management,

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and preventing relapse to regular drug use will assist a substantial proportion of methadone patients with successfully completing therapy.

HCV Healthtips

Diana Sylvestre is a physician and Assistant Clinical Professor of Medicine, UCSF.

by James Learned She is the Executive Director of O.A.S.I.S., in Oakland, CA.

Reprinted fromHarm Reduction Communication, Summer, 2002

References

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1. Alter MJ. Epidemiology of hepatitis C. Hepatology 1997; 26:62S-65S. aybe you’ve just found OUT THAT you have hepa2. Alter MJ, Mast EE, Moyer LA, Margolis HS. Hepatitis C. Infect Dis Clin tNor h titis C (HCV). Maybe you’ve known for years and Am 1998; 12:13-26.

3. Thomas DL, Vlahov D, Solomon L, et al. Correlates of hepatitis C virus infechave avoided dealing with it. Or maybe you’ve put tions among injection drug users. Medicine (Baltimore) 1995; 74:212-20. off being tested because you’re scared. Whatever the case, 4. Zeldis JB, Jain S, Kuramoto IK, et al. Seroepidemiology of viral infections among intravenous drug users in nor thern California. West J Med 1992; 156:30-5. don’t panic! Sure, the prospect of dealing with a viral infec5. Garfein RS, Vlahov D, Galai N, Doherty MC, Nelson KE. Viral infections in tion can be frightening, and chronic HCV infection can short-term injection drug users: The prevalence of the hepatitis C, hepatitis B, sometimes lead to serious liver disease, even liver failure and human immunodeficiency, and human -lyTmphotopic r viruses. American Journal of death. But our understanding of HCV is growing every day.

Public Health 1996; 86:655-661.

Recent advances in treatment, particularly the new pegy6. McCarthy JJ, Flynn N. Hepatitis C in methadone maintenance patients: eva-pr lence and public policy implications. J Addict Dis 2001; 20:19-31. lated interferons, have understandably led many health care 7. van den Hoek JA, van Haastrecht HJ, Goudsmit J, de Wolf F, Coutinho RA.providers and people with HCV to rush to treat. Some docPrevalence, incidence, and risk factors of hepatitis C virus infection among ug dr tors suggest treatment right away, no matter what. But there’s users in Amsterdam. J Infect Dis 1990; 162:823-6.

8. Bell J, Batey RG, Farrell GC, Crewe EB, Cunningham AL, Byth K. Hepatitis C usually no need to rush into treatment. The effectiveness of virus in intravenous drug users. Med J Aust 1990; 153:274-6. interferon, including the pegylated versions, is limited, and 9. Gerberd ing JL. Incidence and prevalence of human immunodeficiency us,vir hepatitis B virus, hepatitis C virus, and cytomegalovirus among health care per- most people experience severe side effects during the course sonnel at risk for blood exposure: final eprort from a longitudinal study. J Infect Dis of treatment.

1994; 170:1410-7.

[Pegylation is a process that keeps interferon in your body 10. Ho SB, Nguyen H, Tetrick LL, Opitz GA, Basara ML, Dieperink E. Influence at more consistent levels than standard interferon. This of psychiatric diagnoses on inter feron-alpha treatment for chronic hepatitis C in a allows for once a week injections, rather than three times a veteran population. Am J Gastr oentero l 2001; 96:157-64.

11. Mason BJ, Kocsis JH, Melia D, et al. Psychiatric comorbidity in methadone week, as well as higher success rates. The FDA approved one maintained patients. J Addict Dis 1998; 17:75-89. brand (PEG-Intron) in January of 2001, and another 12. Milby JB, Sims MK, Khuder S, et al. Psychiatric comorbidity: prevalence in methadone maintenance treatment. Am J Drug Alcohol Abuse 1996; 22:95-107. (Pegasys) became available in late 2002.]

13. Davis GL, Rodrigue JR. Treatment of chronic hepatitis C in active drug users. Figuring out whether or not to begin treatment for HCV is N Engl J Med 2001; 345:215-7. complicated. It’s even more complicated if you’re also living 14. Backmund M, Meyer K, Von Zielonka M, Eichenlaub D. Treatment of hepatiwith HIV. This is a very personal and individual decision. tis C infection in injection drug users. Hepatology 2001; 34:188-93.

15. Lai ME, Mazzoleni AP, Argiolu F, et al. Hepatitis C virus in multiple episodes of Take into account what’s going on in your life, including the acute hepatitis in polytransfused thalassaemic children. Lancet 1994; 343:388-90. type and degree of your drug use, the level of emotional sup16. Tisone G, Baiocchi L, Orlando G, et al. Hepatitis C reinfection after liver trans- port available to you and whether you’re prepared for six plantation in relation to virus genotype. Transplant Proc 1999; 31:490-1.

17. Wyatt CA, Andrus L, Brotman B, Huang F, Lee DH, Prince AM. Immunity in months to one year of sometime debilitating treatment. chimpanzees chronically infected with hepatitis C virus: role of minor quasispecies Learn everything you can about HCV, see a health care in reinfection. J V irol 1998; 72:1725-30. provider regularly, keep track of your lab results, and take 18. Bangsbegr DR, Hecht FM, Charlebois ED, et al. Adherence tootpr ease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent pop-care of your liver—you only have one, and there’s lots you can do to keep it as healthy as possible. ulation. Aids 2000; 14:357-66.

19. Knobel H, Carmona A, Grau S, Pedro-Botet J, Diez A. Adherence and fec-ef tiveness of highly active antir etroviral therapy. Arch Intern Med 1998; 158:1953.

20. Van Thiel DH, Friedlander L, Molloy PJ, Fagiuoli S, Kania RJ, Caraceni P. Moitoring Liver Health: Diagnostics & Tests With chronic HCV infection, no one can predict who will Interferon-alpha can be used successfully in patients with hepatitis uCs-vir positive chronic hepatitis who have a psychiatric illness. Eur J Gastr oenterol Hepatol 1995; live for decades without symptoms and who will develop 7:165-8. liver scarring (fibrosis, cirrhosis) or liver cancer. Find a doc21. Van Thiel DH, Friedlander L, De Maria N, Molloy PJ, Kania RJ, Colantoni A. Treatment of chronic hepatitis C in individuals with pre-existing or confoundingtor who understands HCV (usually a gastroenterologist or neuropsychiatric disease. Hepatogastr oenterology 1998; 45:328-30. hepatologist) and work with him or her to monitor how your 22. Pariante CM, Orru MG, Baita A, Farci MG, Carpiniello B. Treatment with liver is doing. Keep track of your test results so that you’ll interferon-alpha in patients with chronic hepatitis and mood or anxiety ddisor ers. have as much information as possible in order to make treatLancet 1999; 354:131-2.

23. Dalgard O, Bjoro K, Hellum K, et al. Treatment of chronic hepatitis C in inject- ment decisions that are right for you. ing drug users: 5 years’ follow-up. Eur Addict Res 2002; 8:45-9.

Liver Function Tests:Liver cells constantly die off and new 24. Koch M, Banys P. Liver transplantation and opioid dependence. Jama 2001; ones grow. A by-product of liver cell damage or death is the 285:1056-8.

25. McCaffrey BR. Methadone treatment: our vision for the future. J Addict Dis secretion of liver enzymes into your blood. Liver function 2001; 20:93-101. tests measure your enzyme levels each time you get blood 26. O’Connor PG, Fiellin DA. Pharmacologic treatment of oher in-dependent work done. If you’re HCV-positive, most doctors will monipatients. Ann Intern Med 2000; 133:40-54.

27. Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A tor your liver enzymes (ALT, AST) every six months. It’s a comparison of levomethadyl acetate, buprenorphine, and methadone for opioidgood idea to get a baseline reading, but your enzyme numdependence. N Engl J Med 2000; 343:1290-7. bers can be affected by so many variants that they’re prima28. Newman RG. Methadone treatment. Defining and evaluating success. N Engl rily useful for comparison purposes over time. Your enzymes J Med 1987; 317:447-50.

29. Sylvestre D, Clements B. Characteristics of methadone patients with active may be high if you’re taking medications, including some hepatitis C, American Society of Addiction Medicine, Atlanta, GA, 2002. anti-HIV medications, as your liver works overtime to break 30. Sylvestre D, Clements B. Treating hepatitis C in methadone maintenance down the drugs. Alcohol and some street drugs can signifipatients, American Society of Addiction Medicine, Atlanta, GA, 2002.

31. Sylvestre D. Treating Hepatitis C in Methadone Maintenance Patients: An cantly damage the liver, resulting in increased liver enzyme Interval Analysis. Drug Alcohol Depend 2002; inespr s. levels. If your liver is in really bad shape, your enzyme levels

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right ribs, into your liver, and a small tissue sample is taken out and examined. It’s used to measure the degree of liver inflammation and scarring. Liver biopsy can be repeated to assess disease progression over time and is particularly important if you’re considering treatment.

Genotype: describes the genetic make-up of your strain of HCV. Of the three main HCV genotypes (1, 2, and 3), genotype 1 is the most common in the US, accounting for about three-quarters of infections.

Unfortunately, it’s also the genotype least likely to respond to interferon treatment. Learning your genotype will give you some statistical information about how likely you are to benefit from treatment. So if you’re considering treatment, knowing your genotype can be very helpful.

may be normal or low because your liver is too worn out.

Bottom line: although extremely important, liver enzyme levels don’t offer a complete picture of possible liver damage.

Viral Load: Also for comparison purposes over time, get a quantitative HCV viral load, which tells you how much virus is in your blood. Don’t freak out when you get the results!

Most people with HCV have viral loads in the millions.

There’s no comparison between HCV viral loads and those for HIV. A viral load of one or two million is considered very high in HIV, but the same result with HCV isn’t necessarily considered high. There’s little information yet about how specific HCV viral load levels relate to the likelihood of current or future liver damage. And HCV levels can fluctuate a lot. So, as with liver enzymes, don’t make treatment decisions based only on viral load results.

Ultrasound Scanning:Some doctors do an ultrasound (sonogram), which uses sound waves to show images of the liver. An ultrasound isn’t invasive, but it can’t tell how much damage your liver has suffered either. The test is better for detecting abnormalities, like tumors, than it is for detecting more generalized problems like cirrhosis. It can locate an obstruction by showing the blood flow in the blood vessels of the liver. Your doctor might use ultrasound as a guide when inserting the needle for a biopsy.

Liver Biopsy:This is currently the best way to measure the degree of liver damage. A liver biopsy is an outpatient procedure that just takes a few minutes while you’re awake. A needle is inserted through your abdomen, just below your

Taking Care of Your Liver In addition to monitoring HCV disease progression and liver health by keeping track of the results of the tests discussed above, do what you can to avoid stressing your liver any further. Drink lots of water!

Obviously, water won’t get rid of HCV, but it’s a relatively simple (and cheap!) way to flush your liver. If you haven’t already done so, get vaccinated against hepatitis A and hepatitis B. If you’re HCV-positive, coinfection with hepatitis B can speed up liver damage.

And getting hepatitis A can be fatal if you already have HCV. Alcohol use increases the risk of cirrhosis enormously, so avoid alcohol if possible, or at least limit the amount you drink. High doses (over 2,000 mg a day) of acetaminophen—Tylenol and other nonaspirin pain relievers—can be extremely toxic to the liver, especially when combined with alcohol.

Try to eat a nutritional, balanced diet. Foods with high salt, sugar or fat content—such as cheese, pickles, fast food and processed foods—can stress your liver. So can shellfish and raw fish. As much as possible, avoid exposure to pollutants and chemicals like cleaning products, paint fumes, paint thinners, solvents, spray adhesives, insect sprays and other aerosol sources. When you breathe in the toxins in these substances or absorb them through your skin, your liver has to break them down, adding further stress.

Many people use certain herbs and supplements to cleanse the liver. Those that are most commonly used and have the most data include milk thistle (silymarin), astragalus, dandelion, bupleurum, garlic, licorice root, vitamin E, artichoke, thioctic (alpha-lipoic) acid and ginko biloba. Of course these and other alternative substances can sometimes have dangerous side effects, especially if taken in high doses. For example, over 800 mg a day of vitamin E can be toxic to your liver. Other supplements can actually harm your liver: peppermint, mistletoe, yerba tea, sassafras, germander, chaparral and excessive doses of vitamins A, D and K. If there’s no indication of liver problems, see your health care provider every six months for regular blood work. If you have cirrhosis you’ll likely have additional concerns around diet and medications, depending upon how advanced the cirrhosis is and how much damage it has caused to your liver.

Talk these over with your doctor, or a nutritionist who’s familiar with liver disease. Be an informed, willing and active partner in your health care. Don’t be afraid to ask questions.

The more you know about HCV, the better treatment decisions you can make for yourself now and in the future.

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Eastern Treatment Options: Traditional Chinese Medicine for HCV

by Misha R Cohen, OMD, LAc Reprinted by permission of NUMEDX Hepatitis [Spring/Summer 2003]

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any people with hepatitis C virus (HCV) are turning to traditional Chinese medicine (TCM) for treatment. TCM has a rich history in the treatment of chronic hepatitis. Hepatitis B and C infections are prevalent throughout China, accounting for the increased risk of hepatocellular carcinoma in the Chinese population. The Chinese medical system has been dedicated to solving these problems for many years. The Chinese are working to eliminate sources of hepatitis, and to develop treatments for chronic viral hepatitis using both TCM and Western medicine.

At the International Symposium on Viral Hepatitis and AIDS held in Beijing, China in April 1991, more than 100 papers on viral hepatitis were presented. Several of these papers documented the positive results of studies involving Chinese herbal medicine. Studies on the use of herbal antivirals and on blood cooling and circulating herbs for liver damage repair were presented. These studies corroborated hundreds of years of treatment experience with Chinese herbs for the symptoms of hepatitis.1,2,3 A 1995 literature review revealed that there are at least 55 herbal formulas that are used to treat hepatitis. 4 Some recent herbal studies from China and Australia showed positive results in hepatitis C using herbal formulas similar to those widely used in the United States.5–7 In the United States, TCM is a popular complementary and alternative medicine (CAM) therapy among patients with chronic liver disease. Anecdotal reports from one of the largest Western medicine hepatology practices in San Francisco suggest that at least 20 to 30 percent of patients report use of TCM herbs for hepatitis.8 The actual use of TCM may be underestimated because patients often choose not to divulge the use of CAM therapies to their Western healthcare providers.

TCM uses nutrition, acupuncture, heat therapies (such as moxibustion), exercise, massage, meditation, and herbal medicine to treat people infected with HCV. Protocols have been developed that have successfully helped people infected with HCV decrease symptoms, normalize or lower liver enzymes, and slow the progression of liver disease. A 1995 pilot study conducted among people co-infected with HIV and viral hepatitis (B and C) at San Francisco’s Quan Yin Healing Arts Center indicated that acupuncture alone may have an effect in lowering and/or normalizing liver transaminases. 9

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Chinese Medicine Philosophy The primary goal of TCM is to create wholeness and harmony within a person, thereby allowing the mind, body, and spirit to self-heal themselves. Chinese philosophy holds that there are two opposing principles of life: yin and yang.

Imbalances between yin and yang within a person can manifest as illness because the body is considered a microcosm of the world.

TCM defines the physiological components of illness using the concepts of qi (vital energy), xue (blood), jin-ye (body fluids), jing (essence), shen (spirit), and organ systems.

Organ systems are domains within the body that govern particular body tissues, emotional states, and activities.

TCM theory contends that the key to health is the internal ability of the body to remain strong. According to this theory, people are born with a certain amount of original qi (pronounced “chee”). The qi is easily depleted as energy is used by the body and not replaced. It is not easy to increase the original qi. A person must work hard during life just to retain it. Exercise such as tai chi and Qi gong, healthy eating, and good sleeping habits are highly recommended for maintaining the original qi. If a person consistently lacks sleep, does not have a healthy diet, abuses drugs or alcohol, and/or has excessive or unsafe sex, he or she becomes qi-deficient.

When weakened and qi-deficient, a person is more susceptible to infection by harmful external pathogenic elements.

Traditional Chinese Medicine Diagnoses for HCV/HIV According to TCM literature, people in China have experienced the various syndromes associated with HCV infection for over 2000 years. This is because TCM diagnoses are based on symptoms, not on detection of antibodies to a specific virus. TCM treatments for these syndromes have been used over the past millennia and are generally considered safe and effective for all patients. However, TCM recognizes that each person has a unique constitution and pattern of disease that exist in conjunction with the age-old syndromes.

TCM contends that the best form of treatment is to modify, alter, or supplement the base therapies to create an individualized treatment that meets each patient’s unique characteristics and needs.

Chinese medical theory holds that viral hepatitis is not a singular disease, but rather is a set of combinations of stages and syndromes. The diagnosis and staging of HCV are accomplished using tongue diagnosis, pulse diagnosis, and questioning according to TCM theory.

According to TCM, in HCV infections toxic heat enters the body. Manifestations of an invasion of heat include feelings of warmth, sweating, agitation, hot sensations, and itching skin.

Examination may reveal a fast pulse and a red tongue. Small red spots on the tongue are a likely finding in nearly all cases of chronic infection ranging from very obvious to barely noticeable.

The organ systems primarily disturbed in hepatitis are the liver and spleen organ systems. These disturbed organ systems affect digestion and energy. According to TCM, acute viral hepatitis is generally associated with excess damp heat or damp cold conditions. While some people acutely infected with HCV may have or notice symptoms, this is relatively rare. The TCM stage at which one is diagnosed with hepatitis C is usually either the chronic stage of qi stagnation, or the stage of qi and yin deficiency. Advanced chronic disease includes development of the patterns of xue stagnation and xue deficiency. All HCV infection is associated with toxic heat or the li qi (the pestilence/epidemic factor).

Traditional Chinese Medicine Therapy for HCV In Western medicine, extremely harmful external elements include severe bacterial or viral infections such as HIV and HCV. However, those terms are inappropriate in TCM. Instead, it is said that Chinese medicine “recognizes the existence of Pestilences called li qi or yi qi. These are diseases that are not caused by the climatic factors of Heat, Cold, Wind, Dampness, or Summer Heat dryness, but by external infectious agents…that are severely toxic because they strike directly at the interior of the body.”10 In the case of HCV and/or HIV, the particular pestilence is identified as toxic heat. Toxic heat is considered by TCM to be both an epidemic factor (something that is seen in a number of patients) and its own individual, treatable syndrome.

The various modalities of TCM therapy include diet, massage, heat therapies, exercise, meditation, and acupuncture: Heat therapies include the use of moxibustion.

Moxibustion is the burning of the herb mugwort over certain areas of the body to stimulate or warm these areas. Also, heated packs, often with herbs inside, are used in TCM therapy.

Exercise therapy ranges from martial arts to more subtle forms of movement such as tai chi and Qi gong. Many centers of TCM include Qi gong or tai chi classes as part of their treatment programs.

Acupuncture is perhaps the most well-known form of TCM in the United States. It is the art of inserting fine, sterile, metal filiform needles into acupuncture points on the body in order to control the flow of energy. Acupuncture therapy can include electrostimulation and/or hand stimulation. This form of therapy is most appreciated for its ability to relieve pain. However, acupuncture is also able to help change body energy patterns, which promotes the body’s ability to heal itself of organic syndromes and symptoms. In these treatments, TCM often does not distinguish energetic effects from physiologic effects.

The different modalities of TCM have different aims.

Some focus on balancing the body’s energy, while others focus on building the physical body and adding substances to both balance and change the body materially. For example, the Enhance® herbal preparation that is widely used in TCM for HIV and HCV contains herbs to tonify the spleen qi, and build xue. Qi tonification increases the amount of energy in the body that is available for certain functions. Qi tonic herbs often have the specific effect of increasing digestion and food absorption. This increases the quality of the blood (xue).

Acupuncture is associated with balancing the body’s energy levels, while herbal substances are more like drugs or food in that they have specific organic effects. Breathing exercises are known to strengthen qi. One meaning of the Chinese word qi is air. By learning how to breathe correctly, more oxygen becomes available to enter the bloodstream.

Chinese herbal medicine treatment for HCV depends on the stage of the disease and the syndromes involved. Herbal medications in conjunction with rest and dietary recommendations can treat the symptoms of acute hepatitis fairly rapidly. Chronic hepatitis C is more difficult to treat.

Research and experience both from China and from TCM clinics in the United States suggest that at least a one-year course of TCM therapy is the minimum needed to alter the progression of HCV. In our clinics, TCM therapy for chronic hepatitis C usually includes combinations of herbal preparations, which are often specifically designed for the disturbed organ system patterns.

Chinese medical theory holds that viral hepatitis is not a singular disease, but rather is a set of combinations of stages and syndromes. The diagnosis and staging of HCV are accomplished using tongue diagnosis, pulse diagnosis, and questioning according to TCM theory.

Combining Eastern and Western Therapies If you decide to use a combination of Eastern and Western therapies, you must discuss all of your treatment approaches with both your Eastern and Western practitioners. For example, the use of some herbal therapies may interfere with interferon therapy. However, Chinese medicine can be highly effective for the management of side effects from drug therapy. TCM may also be used as an alternative to Western drug therapy in some cases.

Misha Ruth Cohen, OMD, LAc is the co-founder and Research and Education Chair of the Quan Yin Healing Arts Center; a Research Specialist at the University of California at San Francisco; and Clinical Director at Chicken Soup Chinese Medicine, all in San Francisco. Visit her web site at: http://www.docmisha.com.

References 1. Chen Z, et al. Clinical analysis of chronic hepatitis B treated with TCM compositions Fugan No. 33 by two lots. International Symposium on Viral Hepatitis and AIDS. Beijing, China. 1991:2. [Abstract] 2. Wang C, He J, Zhu C. Research of repair of liver pathologic damage in 63 cases of hepatitis with severe cholestatis by blood-cooling and culcir ation-invigorating Chinese herbs. International Symposium on Viral Hepatitis and AIDS. Beijing China. 1991:5. [Abstract] 3. Zhao R, Shen H. Antifibrogenesis with traditional Chinese herbs.nInter ational Symposium on Viral Hepatitis and AIDS. Beijing China. 1991:20. [Abstract] 4. Ergil K. Fifth Symposium of the Society for Acupuncture Research Confer ence.

Herbal Safety and Research Panel. Palo Alto, California: Society for Acupuncture Research Conference; 1998.

5. Batey RG, Benssoussen A, Yang Yifan, Hossain MA, Bollipo S. Chinese herbal medicine lowers ALT in hepatitis C. A randomized placebo controlled etrial portr.

Sydney, Australia: Cathay Herbal Laboratories; 1998. [Note: At the time of publication, this unpublishedeprort was available online at the Cathay Herbal Laboratories Internet site: www .cathayherbal.com/library/CH100/ Clinical_Research/clinical_research.htm.]

6. Li H, et al. Qingtui fang applied in treating 128 cases of chronic hepatitis C. Chinese Journal of Integrated Traditional andesW tern Medicine for Liver Diseases.

1994;4(2):40.

7. Wu C, et al. Thirty-three patients with hepatitis C treated by TCM syndrome differentiation. Chinese Journal of Integrated Traditional andesW tern Medicine for Liver Diseases. 1994;4(l):44–45.

8. Gish R. California Pacific Medical Center, San Francisco. Personal communication, 1996.

9. Cohen MR, Wilson CJ, Surasky A. Acupuncture treatment in people with HCV and HIV coinfection and elevated transaminases. 12th International Conference on AIDS, Geneva, Switzerland, 1998. [Abstract 60211] 10. Cohen MR, Doner K. The HIV Wellness Sourcebook. New York, NY: Henry Holt & Company; 1998.

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LIVER HEALTH: Listening to Experience Three reports of using alternative therapies to address hepatitis C JASON: I tried Chinese herbal remedies for several months but didn’t stick with it long enough because it was too high-maintenance. I had to prepare tea every morning and this is in conflict with my personal philosophy about hepatitis C, HIV or any disease: I don’t like to put a lot of energy into addressing it, I don’t want to be consumed by it .

Then I tried clinical trials with Interferon which produced some really good results despite the side effects. I was on it for six months and when I went off, my liver enzymes increased again. I then played with Western Herbal treatment in the form of cap sules but it didn’t significantly reduce liver enzymes. So, I started again on Interferon which has been very beneficial, but had a problem with the daily injections of 3 million units, 3 times a week—I didn’t like the bruising or the side effects: flu like symptoms, achy and lethargy. So, I figured out a schedule of 1.5 million units every day which reduces side effects and still produces the same results. I then discontinued after a year because I got tired of the bruises on my legs and stomach.

Presently, I am back to the Western Herbal capsules: HepatoPlus formula from a health food store. I’ve had no side effects, and I’m still awaiting a liver panel. I use herbal medicine as a respite from and in conjunction with Interferon, but I also adjust the Interferon regimen so that it works for me. You have to find something that works and feels right for you.

MARK: I never used Interferon, instead I’ve been using tinctures (liquid extractions of dry herbs taken out of a dropper bottle— see below) of the following western herbs: Dandelion root, Milk Thistle, Echinecea, and Licorice. My liver panels are excellent, my doctor said not to worry, one of my panels is normal, the other is slightly elevated. Before I started herbal therapy, my liver levels were very high. (Mark also exercises consistently which is very important for detoxifying the body).

JOY: I am on a Chinese Herbal regimen. After speaking with a lot of people, some using interferon and others using alternative therapies, I decided to use Chinese Herbal Medicine instead of Interferon because everyone on the latter complained about the side effects and felt sick, when they hadn’t felt sick before taking it. All of the folks who took alternative medicine felt physically and mentally better and have better results with less stress. I have done a lot of research, and the recovery rate is really small with Interferon. I also didn’t want to inject.

I am working with a Chinese medicine practitioner who has created several Chinese herbal formulas for me. I only take one of the formulas at a time, but I rotate formulas every two weeks to prevent any one of them from losing its effectiveness. The Chinese medical practitioner also adds various herbs depending on the current condition of my system. In order to take the herbs, I make a tea every morning and drink it. I only have to do this once a day. Every three to four months I stop with the cooked herbs for 2 months and take herbal pills, and then I go back to the teas.

My Western medical doctor gives me liver panels every 6 months. One of my panels is within the normal range, the other is slightly elevated. My doctor is not concerned; both of my panels have gone down since I’ve used the Chinese herbs and I have had no side effects.

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An Herbal Approach to Managing Hepatitis C

by Donna Odierna

Reprinted fromHarm Reduction Communication, Summer, 2002

Herbal Allies for People Living With Hepatitis C any people living with Hepatitis C use holistic, alternative and complementary therapies to improve health and quality of life. Many find themselves enjoying the best health of their adult lives. Herbal medicine has much to offer. There are many systems of herbal medicine (Traditional Chinese Medicine, Ayurveda, Kampo, Tibetan and others). What follows is a collection of suggestions from the perspective of modern western herbal medicine.

Some herbs, like dandelion, milk thistle, burdock and lemon balm, are nontoxic and can benefit almost anyone with HCV. Some herbs, though, are much better for some people than for others, should be taken only for short periods or are toxic in high doses. Always research any herbs you are thinking of taking, and check with an herbalist if you have any questions.

M

General Herbal Support Milk thistle (Silybum marianum), seeds, 1-3 tsp. or as standardized Silymarin 80%, 200mg, three times a day. Milk thistle’s “active constituent,” Silymarin is actually a hepatoprotective flavonoid complex. The seeds themselves also contain beneficial fiber and essential fatty acids. Milk thistle is non-toxic, and safe for long-term use. Many people who take milk thistle find that their ALT levels are reduced, and sometimes return to normal. Because ALT levels are one of the many items doctors monitor to gauge the success of HCV medical treatments, it is important to tell your doctor if you are using milk thistle or other herbs.

Dandelion root (Taraxacum officinale), #00 capsules, 2-4 capsules 3-4 times a day. Use when the liver is inflamed, or under stress from solvent use, drinking, etc. Indications for use: constipation, light-colored stools, poor digestion of fats, jaundice, soreness or swelling of the liver.

Immune Tonics A strong immune system is thought to be crucial in limiting viral replication and liver damage. Immune tonics can be incorporated into daily routines as ingredients in foods, soups and teas. Herbs that support immune responses include: Shiitake mushrooms (Lentenula edulus ), elderberry (Sanbuccus nigra), astragalus (Astragalus membranaceous ) and antivirals such as lemon balm and garlic.

Alteratives These are herbs that cause gradual and deep change, improving the body’s ability to detoxify: Red clover (Trifolium pratense), burdock (Arctium spp.), nettles (Urtica dioica), etc.

These are especially important for long-term strategies and for people recovering from drug therapies (or from drug

throughout the day, refilling the bottle when empty. At the end of the day, discard the used berries, and start fresh the next morning. Tangy and refreshing. Supports liver, lungs, and kidneys in removal of toxins from the blood.

IMMUNE POWER SOUP: 4-6 dry shiitake mushrooms, 4 large slices astragalus root, 2 small slices cultivated American white ginseng root, 6 whole cloves garlic, several slices of fresh ginger root, 1 cayenne pepper. Add the herbs to 2 quarts of water or broth, along with any vegetables that strike your fancy (or use bouillon cubes or plain water). Bring to a boil, lower heat, simmer at least 45 minutes Strain, drink broth, eat the shiitakes. For extra “oomph,” place a clove of finely chopped garlic in a tablespoon of olive oil, let stand at least 10 minutes, add to soup when it is done. Other possible last-minute additions: 2 tablespoons flax seeds, 3-8 tablespoons of miso (depending on variety). Have this several times a week. Extra benefit: keeps colds and flu at bay!

addiction). It is helpful to change these seasonally and/or to choose an alterative that is a good “fit.” Burdock is great in the fall, and for people with skin conditions; it builds and strengthens. Red clover is calming, and it gently corrects many of the hormonal imbalances women experience after using birth control pills or opiates—and while in menopause. Nettles helps the body in times of stress and exhaustion, supplying a deep energy to the whole system.

These should be drunk as tea, 2-4 cups a day, for up to three months at a time. And burdock root is delicious in soups and stews (look for “gobo root” in Asian markets).

Some Favorite Herbal Brews for Liver Health LIVER LOVIN’ TEA: 2 parts burdock, 1 part dandelion root and leaf, 1 part schizandra, 1/4 part licorice root. (Do not use licorice root if you have high blood pressure, or if you tend to retain fluids). Place 1 ounce tea mix and 5 cups cold water in a non-reactive (made of something other than aluminum: aluminum can react with what you’re heating) pan. Slowly heat to simmering, then simmer for 10 minutes and remove from heat. Let sit until lukewarm, strain and drink throughout the day. Make a fresh batch every day. Supports digestion and liver function.

SCHIZANDRA REFRESHER: Place 1 tablespoon of schizandra berries in a quart bottle of spring water. Sip from the bottle

Herb Cautions Warnings about specific herbs and herbs in general may be found in most books about hepatitis C, on hepatitis C web sites and in many doctors’ offices. Some of these warnings are clearly based on weak theory and speculation, others on clinical data and common sense. Skullcap is on nearly every warning list, not because of its effects, but because it has sometimes been adulterated with hepato-toxic germander. It is clear that we should be using high quality, correctly identified herbs, and that HCV patients need to get their herbs from impeccable sources. Also, pregnancy and many medical conditions require special caution when using herbs and medications. Check with your health care provider and your herbalist. That said, the following herbs should be avoided when working with HCV patients—or used with caution only by people who understand them: Herbs that contain hepato-toxic pyrolizidine alkaloids, which can cause veno-occlusive liver disease, a rare but potentially fatal condition: Comfrey (Symphytum officinale ), Coltsfoot (Tussilago farara), most Senicio species, etc.

Other possibly dangerous herbs: Chaparral (Larrea tridentata), Ma huang (Ephedra vulgaris), Aristolochia species (Snakeroot, Indian root). The FDA recommends that these herbs not be sold for internal use.

Herbs that may be useful for some people, and dangerous for others: Licorice root, Bupleurum (American Bupleurum, Thoroughwax), Lomatium (Leptotaenia, Biscuit Root), Isatis, and others. Check with an herbalist before using these.

Until further research is conducted, it is advisable to avoid using St. Johnswort if you take protease inhibitors, or certain other prescription drugs, including methadone. Check with your medical provider and a trained herbalist.

AND DON’T FORGET: Diet is a very important part of HCV

management. Herbs won’t work as well if nutritional intake is inadequate—or if the foods that are eaten stress the liver.

Exercise, massage, saunas, energy work, acupuncture, breathwork and meditation lend themselves to detoxification, relaxation, increased energy and optimal health.

Gradual change is the key to long-term change; HCV is a chronic condition that most patients will live with for decades. Slowly add liver-healthy changes into your daily routines, so they become easy to live with for the rest of a long, healthy life.

Donna Odierna is a herbalist, nutritionist and health educator. She currently balances her time between private practice in Oakland and the Public Health doctoral program at UC, Berkeley ..

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Liver Biopsy

by Douglas T. Dieterich, MD

Reprinted fromHepatitis C Review, © 2003 by NATAP

The mere mention of the two words “Liver Biopsy” strikes fear into people’s hearts. They have heard all sorts of horrific things about the procedure: it’s more painful than childbirth, the needle is the size of a harpoon, there are large incisions and scars. Nothing could be further from the truth. It is a very benign procedure that is vital to diagnose liver disease.

Why do a liver biopsy in the first place? In people with viral hepatitis B and C it really determines the stage of damage done by the viruses. The pathologist usually grades the fibrosis or scarring of the liver on a 0-4 scale. Four is cirrhosis and is often considered irreversible (although recent data seems to contradict that). We try to avoid that outcome whenever possible. Zero is no fibrosis, which means there has been no damage to the liver yet. The NIH guidelines for treating hepatitis C recommend treatment for any fibrosis of grade 1 or more. We also know the time it usually takes for a biopsy to progress from one grade to another. The median time (the time for half the people) to progress to cirrhosis from a grade 3 biopsy is about 18 months, while the time to cirrhosis from a grade 1 biopsy is about 12 years. The liver biopsy can be very helpful information in determining when to treat some-one’s hepatitis. If they want to wait 6 or 12 months, that is fine with a grade 1 biopsy, but quite scary with a grade 3! It is also very important to know if someone has cirrhosis. If they do we need to look inside their esophagus for varicose veins called varices that can bleed catastrophically. When we look we can also treat them with rubber banding or injection and prevent them from bleeding.

Progression of hepatitis is, in general, accelerated in HCV/HIV co-infected individuals. Studies so far find HCV progression in co-infected patients may progress 1.5 to 4 times more quickly than in patients with HCV infection alone. I always add one stage to my mental calculations when I have an HIV+ patients’ liver biopsy results.

There are other reasons to do a biopsy. The biopsy can help us diagnose other liver diseases that we might have missed.

For example, a patient of mine with hepatitis C had a biopsy a few years ago to stage his disease. The results showed that he suffered from vitamin A overdose and that was damaging his liver more than the hepatitis. He was unaware he was taking too much of the potentially liver-toxic vitamin A. He stopped it. Then we repeated the biopsy a year later, and the hepatitis C damage was now visible. He is now getting treatment for his hepatitis C. In patients with HIV, everything is more complicated, and the liver biopsy may be even more important. One patient with both HIV and HCV on his biopsy demonstrated that he also had hemochromatosis, a disorder of iron metabolism that can be treated by donating blood. Another woman whose biopsy I just did recently had a large amount of fat on the biopsy as well as cirrhosis. This kind of fat was characteristic of the toxicity of the D4T that she was taking.

We substituted another drug for her D4T and will treat her HCV in a few months after the toxicity subsides. Finally, in HIV patients the AST and ALT blood tests (which everyone calls liver “function” tests but are not really function tests at all) may not be elevated, but the biopsies can still reveal cirrhosis or severe liver damage. This is more common in

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We usually ask you to take a breath in, blow it all the way out and then hold it for a second or two. After we do the biopsy most patients say “Is that it?”

HIV+ patients, but can still happen in the HIV negative patient as well.

So now you know why we do a biopsy. Let’s talk about how we do it. First we make an appointment for a blood test within a week of the biopsy to make sure that your blood will clot well. That usually consists of a platelet count and a Prothrombin Time Ratio test. Some hospitals (and the test is done in the hospital) also get a blood type test at the same time. The biopsy requires about a 4-5 hour stay in the hospital. I like to sedate a patient before the biopsy, although many doctors do not routinely do this. I use Demerol and Versed (which is like Valium) to relax people. It is not anesthesia, but like a cocktail or two to help you relax (obviously alcohol is not encouraged in people with liver disease). After the nurse gives you the injection, we wait a few minutes for the drugs to take effect. Then we outline the spot on your right side where we will insert the needle. We clean it thoroughly with iodine and let it dry. Next comes the lidocaine, which is the local anesthesia. It first burns for a few seconds as it goes in and then the area becomes numb. We take that needle out and put in a slightly longer one to numb the deeper area. Finally we use the biopsy needle. We usually ask you to take a breath in, blow it all the way out and then hold it for a second or two. After we do the biopsy most patients say “Is that it?” Some people feel a little pressure or punch, some do not. Afterwards we ask you to lie on your right side for a few hours to prevent bleeding and stay in bed for a few more hours. Some people feel a little right shoulder pain for an hour or so after the biopsy. The most common risk associated with liver biopsy is bleeding. Less than one in a thousand people will have significant bleeding, and less than one in ten thou-sand may have a fatal outcome. When you are ready to go home, you will be instructed not to take aspirin or ibuprofen for a week or so. Tylenol is fine for pain, but it is rare that there is any pain from the liver biopsy site.

Also we would recommend no strenuous exercise that might trigger bleeding.

It generally takes several days to a week for the pathologists to complete their evaluation of a biopsy. I usually suggest an appointment to discuss the results so we can put the whole thing in context. However, many patients are anxious and want the results over the phone as soon as possible, which is understandable. An appointment should still follow that conversation so that there are no misunderstandings and a treatment or no treatment decision is a well-informed one.

If you need a liver biopsy then you should certainly not let irrational fears or bad information prevent you from having one. The information obtained is very valuable and can only assist you and your doctor in making the best possible decisions concerning your health.

Diet and Hepatitis C

by Jocelyn Rodriguez, MPH, RD, CDN

Reprinted fromHepatitis C Review, © 2003 by NATAP

The HIV epidemic redefined interdisciplinary medical care toward infectious chronic diseases. As infectious diseases became manageable via medication, education and lifestyle changes, nutritional intervention played a greater role in helping to achieve good quality of life. Hepatitis C embodies this new paradigm (approach to treatment of diseases), and nutritional advice on eating habits and supplements has proliferated since hepatitis C was identified in the early 1990’s from the former non-A, non-B hepatitis.

Dietary interventions have been used since the first days of treating cirrhosis, but seldom have doctors and dietitians advised dietary changes as prevention of or delay to the progression of the liver toward a cirrhotic state. The Europeans are ahead of the United States in focusing on liver health, i.e. milk thistle for liver function assistance and amino acid formulas for liver regeneration; however, results remain inconclusive.

Nonetheless, we may yet benefit from their treatment suggestions in the management of hepatitis C. (Editorial Note: recently reported research data suggested that milk thistle might cause a drug interaction with HIV medications, thus affecting the blood levels of HIV medications. At the IAS Conference in Buenos Aires (July 6-11, 2001), Steve Piscitelli (Pharmacologist) reported on new recently completed research from the NIH. Preliminary results of exploring indinavir (Crixivan) and milk thistle for 3 weeks did not show clinically significant interactions. This suggests that milk thistle should not have a drug interaction with HIV antiretroviral pro-tease inhibitors and NNRTIs. However, there is a question whether milk thistle is effective. There is a little preliminary research suggesting milk thistle may be helpful for the liver.

However, the evidence is not strong. In taking herbal supplements for the liver, the question one needs to ask is, “Is the herb potentially harmful to me?” Some herbs have been shown to be harmful to the liver. It appears as though milk thistle may not be harmful, but the data on interactions with HIV meds from Steve Piscitelli is preliminary and still being analyzed.)

The question remains whether we should be proactive about early dietary changes for persons infected with hepatitis C but who have not manifested symptoms of liver failure?

While an ounce of prevention is worth a pound of cure, changing eating habits is very difficult to make and harder to adhere to. Recommending vitamin and herbal supplements can get expensive and may not significantly increase quality of life. This by no means implies that persons with hepatitis C should not pay attention to their dietary habits and nutritional requirements. Each individual will need to be evaluated by a dietitian with experience in liver disease to determine his or her own requirements. The reason for this is because people do not select their diets based on physical and/or medical requirements alone, but also from their cultural upbringing, access to food/meals, and certain habits set by choice and convenience.

A nutritional foundation of dietary practices should be the guide for persons with hepatitis C, especially at times when there are no gastrointestinal symptoms and liver function tests are normal or mildly elevated with no other clinical abnormalities: 1. Get half of your daily calories in carbohydrates. Whole grain starches, vegetables and fruits should be the mainstay of carbohydrates. Sugar and sugary foods, like donuts and candy bars, should be minimized.

2. Keep protein intake up. Have some protein at every meal.

Portion matters more than kind of protein. Make sure to include beans and tofu products, nuts, and dairy products.

3. Moderate fat consumption. Cutting back sugary foods tend to reduce fat intake. Nuts and tofu, which are protein sources, have a healthy amount of unsaturated fat. Use vegetable oil and butter sparingly. The goal in reducing fat intake is mainly for weight purposes.

4. Maintain or achieve desirable body weight. Those who are obese, more than twenty pounds over their ideal weight for height, should lose weight. Those who are mildly overweight should watch out for insidious weight gain.

There is controversy regarding eating red meat for the HCVinfected person. There is preliminary and limited research suggesting that iron accumulation in the liver may accelerate HCV progression, so some think that eating red meat or eating excessive amounts of red meat may contribute to iron accumulation in the liver. However, it has not been established by research that eating red meat actually has the clinical effect of accelerating HCV. If a person has decompensated liver disease certain diet restriction is considered. Many leading hepatitis doctors do not feel restricting intake of red meat is recommended for HCV-infected patients with chronic infection. It is important to bear in mind that in a person co-infected with HIV and HCV, anemia may be a concern and adequate intake of red meat may be important.

Marion Peters, MD, Hepatologist and GI specialist at UCSF says, “If a patient has encepholopathy, which can occur as part of decompensated cirrhosis, they should limit their protein intake, but not necessarily eliminate red meat. Iron accumulation can be a problem only if you eat excessive amounts of red meat. Otherwise, eating red meat is fine and in fact could be part of your diet. Just don’t eat red meat three times per day. If you are taking HCV therapy (interferon, interferon/ribavirin) you should indulge yourself a little to increase caloric intake and particularly it’s ok to eat red meat.” Dr. Peters says the studies suggesting iron accumulation in the liver can be a problem is when iron intake is very high and excessive.

On the topic of iron storage in the liver and it’s potential harm, Ms. Rodriguez says: “From a nutrition perspective, the following is known— 1. Iron is poorly absorbed through the GI tract. Heme-iron (i.e. meats) has a better absorption rate but is not 100%. Non heme-iron (i.e. fortified flour, cereals, spinach, etc) is better absorbed with meats, yet still not at 100%. Therefore, at any given high iron meal a maximum of 40-50% of iron is absorbed.

2. During inflammation (i.e. fever) iron storage in liver is increased. Diabetics and certain substance abusers may have conditional hemochromatosis. (a hereditary disorder of iron metabolism characterized by excessive accumulation of iron in tissues, diabetes, liver dysfunction, and a bronze skin pigmentation).

3. As for HCV, earlier studies suggested that increased liver iron levels elicit liver oxidative stress, with consequent steatosis (fatty liver) and glutathione depletion.” (Iron storage, lipid peroxidation and gluthathione turnover in chronic anti-HCV positive hepatitis. J. Hepatol 1995 Apr;22 (4):44-56 , Therapy of hepatitis C: other options. Hepatology 1997 Sep;26 (Suppl 1): 143S - 151S.) For HCV+ individuals it is recommended not to take iron supplementation. If taking a multiple vitamin get one that says ‘no iron’ on the bottle. Ms Rodriguez says the question of whether to restrict iron intake needs to be considered individually, taking into consideration person’s dietary habits, bloodwork, meds, physical health, and medical history. It is safe to say, that for men with elevated iron levels (serum ferritin especially), taking a multivitamin without iron is recommended.

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4 Hepatitis C: It’s Impact on Our Communities among black patients at 11%. However, they also observed a higher proportion of genotype 1 infection in the black patients. When they looked at genotype 1 patients who received unmodified interferon alfa-2b and ribavirin, the sustained virologic response rates were similar with 22% for white and 23% for black patients. These data suggested that

by Andrew J. Muir, MD, MHS, Duke University genotype and not race was the critical predictor of a response.

Reprinted from HCV Advocate’s Medical Writers’ Circle, a publication With these conflicting results and growing concern regardof the Hepatitis C Support Project. Visit their web site at ing HCV in African Americans, the National Institutes of http://www.hcvadvocate.org. © May 2003 Health sponsored a workshop in December 1999 to review previous work and plan future research in this area. One clear finding was the under representation of African Americans in he advances of the last decade in our understanding HCV treatment trials. Even in the more recent trials with the of hepatitis C virus (HCV) infection have led to sigpegylated interferon alfa regimens, enrollment of black nificant improvements in treatment responses. patients has been extremely low. As a result, NIDDK launched However, data has also emerged that HCV may behave difthe VIRAHEP-C Study (Viral Resistance to Antiviral Therapy ferently in certain populations of patients and particularly in of Chronic Hepatitis C). This study is being conducted at African Americans. This article will review our current eight medical centers in the United States and will examine understanding of this issue and discuss ongoing research the treatment responses of African Americans but will also projects and future directions. examine the immune response, virologic kinetics, and genetOne of the initial reasons for concern about HCV in ic factors to better understand the reason for any disparity in African Americans was the disparity in prevalence. The treatment response. For more information about this study, go NHANES III survey has been our best source for epidemioto: http://www.edc.gsph.pitt.edu/virahepc/index.html. logic data about HCV. A report using these data estimated In addition to VIRAHEP-C, other studies are currently that 1.8% (3.9 million) of the U.S. population had a positive examining treatment issues for African Americans with HCV HCV antibody test but found this rate was higher in blacks infection. Our group is currently completing a study of 100 than among whites (3.2% versus 1.5%).1 The study also African American and 100 non-Hispanic white patients with found that 74% of these people had chronic infection, and HCV infection. The enrollment was balanced for genotype, again the rate of viremia was higher in blacks than whites and 98% of patients in each group were genotype 1. All (86% versus 68%). Black men had higher rates of infection, patients received 48 weeks of pegylated interferon alfa-2b and the highest prevalence rate was 9.8% among black males and ribavirin. To date, we have reported our preliminary ages 40 to 49 years. After adjusting for socioeconomic status results.5 After 12 weeks of therapy, 58% of Non-Hispanic and high-risk behaviors, race was not a risk factor for HCV Whites had no evidence of HCV RNA versus 28% of African infection.

Americans. This difference was highly statistically significant.

Although the prevalence of HCV is greater in African Patients are currently completing the follow-up phase, and Americans, natural history data has suggested a more favorwe anticipate final results later this year. A similar study by able outcome for African Americans. A recent study examDr. Lennox Jeffers and his group at the University of Miami ined the progression of HCV in African Americans.2 African is treating 78 African Americans and 28 Caucasians with Americans were more likely to be infected with genotype 1 pegylated interferon alfa-2a and ribavirin. Their 12-week virus (88%) than were non-African Americans (67%). HCV data also showed a disparity in virologic response with 28% RNA levels were similar, but liver enzymes (ALT) were lower in the African Americans and 50% in the Caucasians.6 This in African Americans. African Americans had less inflammastudy should also have final results later this year. tion and fibrosis in their liver biopsies, and there was a trend Other studies have also improved the enrollment of toward less cirrhosis (22% versus 30%). The authors theoAfrican Americans and will add to the knowledge in this rized that these findings might be explained by a difference field. The WIN-R trial has more than 4000 patients, and in the immune response of African Americans, and further almost 10% are African American. This study is ongoing, and research is investigating this question. the treatment regimen is pegylated interferon alfa-2b and Although the improvements in response rates with current weight-based ribavirin. This study has already provided therapeutic regimens have been encouraging, reports have valuable information regarding treatment of HCV in African also emerged during the last several years that the response Americans. African Americans have lower neutrophil counts rate is lower in African Americans. The initial report by at baseline. Treatment with interferon alfa regimens lowers Reddy and colleagues detailed the experience of patients the neutrophil counts, and there has been concern that this treated with unmodified interferon alfa-2b and interferon would lead to an increased risk of infection. In an early alfacon-1 (also known as consensus interferon).3 In this report from the WIN-R trial, they found that African group, only 1 of 40 black patients (2%) had a sustained viroAmerican patients did have lower baseline neutrophil logic response. Several other reports then followed with simcounts, but the neutrophil counts during treatment were ilarly dismal response rates. A report by McHutchison and similar for African Americans and whites.7 A recent report colleagues challenged these findings and reported the experifrom Soza and colleagues also confirmed that black race was ence with treatment with unmodified interferon alfa-2b and associated with this baseline neutropenia.8 However, neuribavirin.4 In this analysis, the overall response rate was lower

Hepatitis C in African Americans

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trophil count decreases were similar in different racial groups, and the infections reported during treatment did not occur in patients with neutropenia. With concerns about risk of infection, current recommendations include an absolute neutrophil count greater than 1500. Using the NHANES III data, these authors also found that 12% of blacks versus 1.5% of non-Hispanic whites had this level of neutropenia.

With so many patients potentially being excluded from therapy and possibly decreased concerns about the risk of infection with neutropenia, future studies should include treatment of African Americans with lower neutrophil counts.

Significant research is ongoing among African Americans with HCV infection. However, what should we tell African American patients who are currently considering therapy? As with patients of all races and ethnic groups, I do not recommend treatment for patients with early stage disease on their liver biopsy. For patients who are recommended treatment, I remind them that none of the large trials have been published at this time, and we should wait to see their final results before making formal recommendations.

Nevertheless, many patients are aware of the literature suggesting a lower response for African Americans in addition to the preliminary findings of the current trials. I also remind all patients that we will evaluate their virologic response at 12 weeks. Recent work has shown that patients are much more likely to respond to treatment if they have negative HCV RNA or at least a two-log reduction from their baseline HCV RNA.9 Although this predictor has not been replicated in African Americans, I find this a reasonable recommendation to my patients. For the patients who do not respond to treatment or elect to not receive pegylated interferon-a and ribavirin, I also make them aware of the large number of therapies in various stages of development for HCV. For interested patients, I encouraged them to consider participating in one of these clinical trials. If we find that African Americans in particular respond well to one of these new therapies, this may provide even greater breakthroughs in our understanding of the pathogenesis of HCV. With the amount of research focused on HCV, I encourage optimism for my patients.

Treatment Denied: Inmates and Hepatitis C

by Charlie Seller

Reprinted fromHarm Reduction Communication, Spring, 2001

I

n mid September, 1998 I became ill: fatigued and weak, I thought I’d caught a bug. By late January, 1999 I’d been diagnosed as suffering from chronic hepatitis C and was taken out of the prison to see a gastroenterologist at a local hospital. I was examined, asked a few questions, told that I would be having a liver biopsy performed in the near future and sent on my way. A coagulation panel (blood coagulation) was also ordered, the biopsy being dependent upon its results. That’s when the trouble began. Actually, the trouble began with the very first blood test back in September: the one which indicated that not only did I have HCV, but that I’d been exposed to HBV, too. Said “trouble” beginning with the fact that no one from Facility Health Services (FCS, the prison’s health care service) even told me I was infected.

(This scenario would repeat itself a year later when an abdominal sonogram found an 18mm. hyperechoic solid in the right lobe of my liver. I found out only after ordering my medical records at a cost of 25¢ per page.) In April of 1999 I was transferred to Attica where I immediately began to ask questions about the liver biopsy the specialist had ordered.

The doctor I saw told me, “You don’t need one.”

By that time, I’d begun writing away for every free piece of HCV information I could get my hands on. I wrote a Grievance against this doctor, and, while spelled with a capital “G” any impression of power is entirely illusory. A direct result of the 1971 Attica prison riot, Grievance is without question one of the biggest slaps in the face that New York State has ever given her inmates. I wrote my Grievance and offered several pieces of evidence in support of my argument beginning with the gastroenterologist’s diagnosis and his orders for a coagulation panel and a liver biopsy. I offered excerpts from the NIH Hepatitis C Consensus Statement of References 19971 including a paper on “The Role of Liver Biopsy”2 by 1. Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C Robert P. Perrillo, M.D., the NIH’s own Consensus Panel virus infection in the United States, 1988 through 1994. New Engl J Med 1999; biopsy expert.

341: 556-62.

No arguments there, right? Wrong. At first, on both facili2. Wiley TE, Brown J, Chan J. Hepatitis C infection in African Americans: its natural history and histological oprgression. Am J Gastroenterol 2002; 97: 700-6. ty levels (the first being that of Grievance and the second that 3. Reddy KR, Hoofnagle JH, Tong MJ, et al. Racial fDif erences in Response to of the Superintendent of Attica), and then in a final response Therapy with Interferon in Chronic Hepatitis C. Hepatology 1999; 30: 787-793. from Albany, the Grievance was denied and in each denial I 4. McHutchison JG, Poynard T, Pianko S, et al. The impact of inter feron plus ribavirin on response to therapy in black patients with chronic hepatitis C. Thewas informed that my case was being followed as per estabInternational Hepatitis Interventional Therapy Group. Gastr oenterology 2000; lished medical protocol. In several responses the medical staff 119: 1317-23. were referred to as “professional medical health experts.” I 5. Muir AJ, Bornstein JD, Killenberg PG. Pegylated inter feron alfa-2b and ribavirin for the treatment of chronic hepatitis C infection in African Americans andasked where I might obtain a copy of this “protocol” and was non-Hispanic whites. A eprliminary report. Gastroenterology 2002; A-630. in turn ignored for 4 months until I sent a Freedom Of Infor6. Jeffers LJ, Cassidy W, Howell C, et al. Peginter feron alfa-2a (40 kD) (Pegasys®) in combination with ribavirin in African American and Caucasian patients with mation Law (FOIL) request to the Chief Medical Officer of the HCV genotype 1: an interimepr ort of a comparative, multicenter, efficacy and safe- New York State Department of Corrections (NYSDOCS). His ty study. Hepatology 2002; 26: 359A. designee informed me that I could get a copy right here in 7. Brown R, Jacobson I, Afdahl N, et al. Racial/ethnicfedif rences in hematologic toxicity of pegylated inter feron and ribavirin therapy: analysis of the WIN-R trial. Attica, and two weeks later I received said copy accompanied by an unsigned note apologizing for the delay.

Hepatology 2002; 36: 292A. 8. Soza A, Everhart JE, Ghany MG, et al. Neutropenia during combination theraThe Hepatitis C Primary Care Practice Guideline ,3 published py of interferon alfa and ribavirin for chronic hepatitis C. Hepatology 2002; 36: March 31, 1999, had, unbeknownst to me, been replaced by 1273-9.

9. Davis GL. Monitoring of viral levels during therapy of hepatitis C. Hepatology a new edition in January, 2000. (The only difference is the 2002; 36: S145-151. date of publication.) The first Guideline is a five page document allegedly based on three references: the same NIH © May 2003, Hepatitis C Support Project. All Rights Reserved. Permission to Consensus Statement of 1997 from which I drew much of reprint is granted and encouraged with credit to the Hepatitis C Support ojecPr t.

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my evidence, a CDC tract from an October, 1998 Morbidity and Mortality Weekly Repor t4 (such a cheery title, no?) and a Federal Bureau of Prisons’ treatment guideline of 1997.5 Please note that the NIH Consensus Statement is, though not a federal government policy statement, the grandaddy of them all, as each of them lists the NIH document as a reference.

After reading the Guideline closely, I quickly realized that the only two mentions of liver biopsy within its pages were made solely in reference to interferon (IFN)/Ribavirin therapy. This “information” was taken directly from the NIH info and then employed in a most singular context—that of IFN therapy. There was absolutely no regard for several NIH paragraphs in the same text regarding the value of liver biopsy in judging the organ’s histological health, and in grading the severity of damage it has suffered.

The director of Grievance, in Albany, wrote to inform me that the Facility Health Services Director (FHSD) had final say over all medical decisions. I wrote back to ask if that wasn’t collusion? How can Grievance ask the doctor I am “grieving” his own opinion of the treatment he is giving me? I never got an answer to that one, but Albany ordered that the coagulation panel be taken and that the “need” for a biopsy would be determined based upon those results.

This is wrong. It is impossible to determine the “need” for a biopsy based upon the panel results because they only tell the physician whether or not you can survive the biopsy.

(The panel is a test that measures the rate at which your blood clots.) Nonetheless, and after many screw-ups on the part of FHS, I gave blood for the panel in October, 1999—seven months from the time it was originally ordered.

I was never notified of the results, nor called back to see the doctor. I wrote to Grievance here in Attica and was most

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Is Dr. Tripoli saying what I think he’s saying? That inmates are mysteriously biologically different from other hepatitis C-infected human beings by virtue of their criminal background alone, and denying them treatment is perfectly okay, because who can tell if they will change their “habits”?

tersely informed that I had in fact been given the results of the panel on August 31, 1999. When I wrote back to correct the Grievance supervisor, I received an arrogant response which stated that, “Dr. orders are not orders but merely suggestions...the FHSD has final say over all medical procedures and has determined that you do not need a liver biopsy at this time.”

Quite frankly, I probably didn’t need a liver biopsy.

Although the jury is still out, many doctors cannot agree as to the usefulness of the procedure in particular instances, but, due to the number of “mistakes” by FHS and Grievance, I continued to push because they seemed so incapable of delivering an informed—or even close to accurate—opinion on their own incompetent behavior. I have come to believe that NYSDOCS/FHS run their show a lot like General Motors ran theirs in the ‘60s: they wouldn’t spend $2.50 per car because the cost of law suits that would result from exploding cars was deemed cheaper. (After their liability was proven, one poor widow won $50 million from them!)

NYSDOCS/FHS is doing exactly the same thing. There is absolutely no doubt in my mind that when a half-dozen HCV+ inmates all tell me that they were sent to the Mental Health Unit by the physician for “evaluation” (upon seeking care for HCV) there is surely something wrong.

I thought I’d caught them here, but it didn’t matter.

Smoking gun, the whole nine yards, it just didn’t matter. I wrote to everyone but the Pope, and I’d be lying if I said I didn’t think of writing to him, too. No help. A few sympathetic ears, but no solid results. I have come to believe that FHS is the biggest open conspiracy I have ever seen. I grew scared. (Not to brag, but I don’t scare too easily.) I dug a little deeper and found out that IFN costs almost $10,000 a year. Turned out the Guideline was so full of errors that I began taking notes to write a paper on them called “Reference Deviations Within The NYSDOCS/Division of Health Services’ Hepatitis C Primary Care Guideline.” You see, the Guideline blatantly discriminates against everyone who is subject to it. Everyone. Helpful “recommendations” under the heading “Considerations For Treatment” like “Successful Completion of ASAT(Alcohol and Substance Abuse Treatment)” place every candidate for IFN / Ribavirin therapy in the category of drug/alcohol abuser. I can think of no other medical therapy that requires one to undergo substance abuse treatment with or without evidence of a substance abuse problem. A certain NYSDOCS nurse administrator informed me that this was entirely within bounds because, as she so delicately put it, “We can’t be expected to

keep treating people who go back and do the same things change the fact that we are most assuredly heading towards again!” them. In fact, in many instances we are already there.

I dug a little deeper. There are only two available HCV It has been determined that as many as 4 million tracts published by NYSDOCS—a May, 1999 article in DOCS Americans (1.8%) are infected with HCV. Between 8,000 and Today,6 a NYSDOCS organ whose articles conveniently con10,000 of these people will die every year from HCV-related tain no by-lines (none of them, and with good cause if the chronic liver disease. HCV is now the third leading cause for article on HCV is any indicator of their fact checking skills) liver transplant. Intravenous drug use is the primary source —and the Guideline. The DOCS Today article stated that of all new HCV infections: sixty percent. As much as 30% of NYSDOCS/FHS would be conducting HCV screening at sevthe national total of HCV cases pass through correctional eral reception facilities. On June 2, 2000 I was informed by facilities each year. Eighty percent of all U.S. inmates have NYSDOCS that the “total” number of HCV positive test used illicit drugs, 1 in 4 parenterally. 11 In a recent reader surresults was 4,441.7 By itself, that is barely 5% of the entire vey conducted by Hepatitis Magazine, prisoners’ issues were NYSDOCS inmate population. No time frame (nor context) listed third from last. 12 was ever offered with these “statistics.” And, even in a most Recent trends demonizing prisoners allow men like Dr. favorable light of, say, two years worth of testing, it is still an Tripoli to suggest that inmates aren’t the same as other incredibly low number when compared to that of California patients. His editorial went so far as to state that “we may end (32%), Texas (28.6%) and even Maryland, which at 38% has up expending valuable resources providing medication to a a higher HCV infection rate among her prisoners than New large number of people who may derive no substantial benYork.8 I dug even deeper. The Guideline says that testing efit in order to prevent complications in a minority.”13 I blink, would be offered to those inmates with a history of high risk I do a double take—who is this man? As prisoners become behaviors. It is not. In fact, a “Don’t Ask, Don’t Tell” policy the latest objects of a “Two Minutes Hate” campaign ambiguseems to be the protocol: they don’t ask, and they don’t tell. ous laws are written and passed, politicians are bought and There is virtually no HCV education taking place here in sold and we forget that we are a democracy—whenever Attica. None! money comes into the picture, that is. Our perceptions of In an editorial printed within the pages of Hepp News/ HIV change are being manipulated (not that they were so very Education Prison Project , published by the Brown University keen to begin with) because by either diversion and/or lameSchool of Medicine, Louis Tripoli, M.D., Vice President of ness, many will not believe that “it” can ever happen. And Medical Affairs for Correctional Medical Services in St. Louis, when “it” does happen to someone else, that is acceptable Missouri and an Adjunct Assistant Professor of Medicine at because “it” is not happening to us.

Johns Hopkins University (who boasts that his organization If history has taught us anything, it is that it repeats itself. is responsible for the health care of about 300,000 incarcerWithout support from the outside, HCV will thrive in prisated individuals in United States) “begged” his colleagues to ons as HCV+ and at-risk individuals are arrested and incarpursue a “rational approach to hepatitis C infection ... Much cerated in ever increasing numbers. And when they are of what we believe about hepatitis comes from content-area inevitably released, less than aware (as long as current polispecialists, such as hepatologists, few of whom have had any cies continue), HCV will be there with them, returning in appreciable experience treating a correctional population. No greater strength. Literal HCV factories, that’s what prisons are long term studies are available to tell us whether those who becoming. These are the trends and directions we are all are selected for treatment in correctional settings will benefit heading in. For in the words of the great Russian novelist, from treatment and maintain behaviors that will reduce the Fyodor Dostoyevsky: chance of future reinfection.” 9 (Ed. note: See “Sick on the inside: “The degree of civilization in a society can be judged by correctional HMOs and the coming prison plague.

Harper's entering its prisons.”

Magazine, August 2003, by Will S. Hylton for more on CMS, Inc.) Charlie Seller is an aspiring author and harm reductionist. He was recently elearsed Is Dr. Tripoli saying what I think he’s saying? That inmates from Attica Correctional Facility. are mysteriously biologically different from other hepatitis C infected human beings by virtue of their criminal backReferences ground alone, and, denying them treatment is perfectly okay 1. “Management Of Hepatitis C.” National Institutes of Health Consensus because who can tell if they will change their “habits”? This Development Statement. March 24-26, 1997. “professional” goes on to suggest that we “ ... are being led 2. Perrillo R. “Role of Liver Biopsy” (presentation). National Institutes of Health down a primrose path by the pharmaceutical companies,”10 Conference on Hepatitis C. March 24-26, 1997.

3. Hepatitis C Primary Care Practice Guideline. New York Department of This echoes the DOCS Todayarticle too closely for comfort.

Correctional Services, Division of Health Services. March 31, 1999.

DOCS Todayeven went so far as to state that HCV awareness 4. “Recommendations for Prevention and Control of Hepatitis irus C V(HCV) in NYSDOCS prisons is due solely to the efforts of pharmaInfection and HCV-Related Chronic Disease.” CDC. MMWR. October 16, 1998.

Vol.47/No.RR-19. ceutical companies trying to sell more drugs. And, while that 5. Federal Bureau of Prisons Treatment Guidelines for Viral Hepatitis. September may or may not be true, as a “fact” it does not lend itself to 1, 1997. any medical debate regarding infection rates, who should or 6. “What Hepatitis C is - and dif ferences from A or B.” DOCS oTday. NYSDOCS. May 1999 should not receive treatment and a host of other incredibly 7. Shepard, M.E. FOIL response. Divison of Support Services, NYSDOCS. June 2, suspicious arguments I am sure Dr. Tripoli and his like/budg2000. et-minded contemporaries have at the ready.

8. Spaulding, A. Hepp News/HIV Education Prison Project. Brown University School of Medicine. Vol. 2, Issue 7. July 1999.

All this is just as outrageous, if not more, as a doctor or 9. Tripoli L. Editorial: “A Rational Approach to Hepatitis C Infection.” Hepp nurse having to call an HMO or an insurance company News/HIV Education Prison Project. Brown University School of Medicine. ol.2,V before they will give you treatment. It begs a rather tedious Issue 7. July 1999.

10. Ibid. question as to who is worth what, and to whom. It should 11. Alter M. “Epidemiology of Hepatitis C.” Hepatitis Alert. Hepatitis Foundation have never happened in the first place and has set a preceInternational. Summer 1997. dent that points in directions most people would rather 12. Schreiner T. Editor’s Letter. Hepatitis. Vol.2, No.2. March/April 2000. ignore or refuse to acknowledge. This, of course, does not 13. Tripoli.

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HEP C Advocates and Activists Needed

by Alan Franciscus

Reprinted fromHarm Reduction Communication, Summer, 2002

A

dvocacy and activism are terms that are sometimes confused because the roles they entail can be similar and often overlap. Activism is defined as the theory or practice of assertive—often militant—action such as mass demonstrations (or strikes) as a means of opposing or supporting a controversial issue, entity or person. Advocacy is defined as the act of actively supporting, that is, pleading or arguing in favor of something, such as a cause, an idea or a policy.

Generally, when we think of activists, we think of people who are strongly assertive and demand immediate change.

What generally comes to mind are civil rights activists, antiwar activists and AIDS and breast cancer activists. In the case of these movements, there has been an undeniable need for immediate change. These dedicated individuals have spoken out and sometimes put their lives on the line to bring about social, economic, medical and other necessary changes.

Activism and advocacy have taken many forms in the past.

One of the first large-scale successes in modern history was achieved by Mahatma Gandhi, in his quest to gain the independence of India from Great Britain by direct, non-violent confrontation. The Reverend Martin Luther King, Jr. was able to draw from Gandhi’s experience to challenge discrimination against African Americans in this country when he led the civil rights movement in the 1960s. In more recent times, AIDS activists have been able to use similar strategies to bring about much needed change for people living with HIV and AIDS. In fact, the AIDS activist movement, which developed in the late 1980s, was the first illness-related group to adopt non-violent, direct action to bring about social change. Since that time, other disease-related causes, such as the breast cancer awareness movement, have been able to learn from these activist/advocacy groups and have brought about changes using similar techniques.

Unfortunately, at this time, the HCV community has only a handful of activists in the U.S. who are trying to bring about greater awareness, more services and better care for people affected by HCV. The majority of these activists have previously been involved as AIDS activists—many still are, fulfilling a dual role in their work in needle exchanges and other harm reduction-oriented agencies and programs—and are mentoring and joining the ranks of HCV activists. On the other hand, there are many HCV advocates across the nation.

These individuals are mainly HCV-positive individuals who have been moved to respond to the lack of awareness and services on the part of the government and other agencies.

The HCV activist/advocacy community emerged in the mid-1990s to tackle many issues that had been largely ignored by the government and the public sector. The Hepatitis C Support Project, the Hepatitis Support and Education Project, Hep C Connection and many others emerged to advocate for the HCV community by supporting and educating both people with HCV and the general public.

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Simultaneously, programs working to prevent the spread of HIV in injecting drug users, like the Lower East Side Harm Reduction Program, the UFO Project and the Harm Reduction Coalition, realized the extent of HCV infection in this population and began work to curtail the spread of hepatitis C among IDUs and to ensure they had access to up-todate-information on treatment and prevention.

As knowledge of HCV has increased, and the organizations that work on the related issues have matured, there has been an accompanying increase in the need to advocate for specific populations with HCV, such as prisoners, and particular issues, like access to affordable drugs. Examples include the HCV Prison Project, a consortium of organizations working to provide support and education to prisoners with hepatitis C, and the Hepatitis Action and Advocacy Coalition (HAAC), started in 1998 to tackle issues that require direct confrontation with pharmaceutical companies and government agencies. There are many other organizations and dedicated individuals who have given selflessly of their time and energy to help bring about greater awareness and more services for the HCV community. However, many more are required to bring about needed improvements in care and services.

Most people believe that it is difficult and time-consuming to be involved in activism or advocacy. This is true for some efforts, but there are many actions that require little time or involvement. An important aspect of activism or advocacy is that it can help those with HCV feel that they can take control of their lives and effect change that benefits both the individual and the community as a whole. In addition, people from every economic, social, racial and political group are needed for fair representation.

What You Can Do ✔ Educating Individuals and the Public As they say, information is power, and people who educate can move mountains. Learn as much as you can about HCV and educate people and organizations, where appropriate.

Make sure you know your facts and pick your fights carefully. Be prepared to back up your views with solid facts, and have copies of reports or studies available to hand out.

Government officials (including those working in public health) have immense power, and access to lots of money.

Look at the work U2’s Bono has done with Jesse Helms. By enlightening Helms on the impact of AIDS in Africa and other impoverished areas, the one-time foe of AIDS funding is now turning into an advocate for it—not just in the Third World, but in the US, too. ✔ Support Groups HCV support groups were one of the first advocacy efforts to emerge. A support group setting can help people with HCV learn about the disease, coping strategies and other important areas. Starting and continuing a support group can be one of the best steps you can take to advocate for the community. ✔ Helping Individual s/Patient Advocacy Helping others can be a very rewarding experience, whether it’s something you take on as an individual, or in a more formal capacity, as part of your work at a service agency (patient advocacy). Many people with HCV have numerous unmet needs. It may not seem like much, but simply listening, running errands, helping sort through insurance issues or accompanying someone to a medical appointment can be a

An example of effective political advocay is the recent campaign to have the NIH HCV consensus statement amended, ending the current recommendation to refuse treatment to anyone who has not been abstinent from drugs or alcohol for at least six months. A letter signed by many prominent community advocates, researchers, public health specialists and clinicians was presented at the 2002 Consensus Development Conference on Management of Hepatitis C to the authors of the new statement. Additionally, supporters of the revisions presented research to support the requested changes. As a consequence of these efforts, the new version of this statement says that “many patients with chronic HCV have been ineligible for trials because of injection drug use (IDU), alcohol abuse, age, and a number of comorbid medical and neuropsychiatric conditions. Efforts should be made to increase availability of the best current treatment to these patients. Because a large number of HCV-infected persons in the United States are incarcerated, strategies should be developed to better prevent, diagnose, and treat these individuals.” ✔ Direct Action AIDS activists pioneered the use of direct action to influence government officials, drug companies, religious leaders and others. Such actions have included demonstrations to influence public opinion, confrontations with government agencies such as the National Institutes of Health to demand more research and visits to drug companies to demand lower prices. HCV activists have followed this lead, for example, by calling for better care for people with HCV in prisons and demanding reduced prices and unbundling of HCV drugs.

tremendous help. If you decide to take on this type of responsibility, be sure to define your role in the relationship from the beginning. It is also important to make sure that you can carry out any commitments you make. ✔ Create Educational and Training Materials This is especially important when working with stigmatized groups like injection drug users and prisoners. Creating and distributing educational materials gets crucial information out to the people who need it, and can also help stimulate changes in policy and clinical practice, as service providers come into contact with new ideas, and stereotypes are challenged. Training can help ensure the replication of such state of the art work. ✔ Political Advocacy Involvement in local and national politics can have a tremendous impact. Check with your local city or county health department or agency and attend meetings addressing HCVrelated issues. Putting together a petition to submit to a local government can be highly effective. Become involved and know your local candidates; send them letters about issues that affect the community.

✔ Community Advisory Boards/ Committees A community advisory board is a group of individuals who represent a community and provide informed recommendations, for example, to a pharmaceutical company or a research team. Local governments, private companies and charitable organizations often have committees that can benefit from the input of members of affected communities. The level of involvement required varies from group to group. Sometimes a voice from the community is all that is needed, but other boards and committees demand a great deal of time and energy. Do your homework ahead of time and take your responsibilities seriously. Remember that you represent the community, and act accordingly.

We can all make a difference in our own way. Many times, I have heard people remark that one person cannot possibly make a difference. This type of sentiment could not be further from the truth. In my advocacy work, I have met extraordinary people who have taken action and made remarkable progress in bringing about more awareness, education, and improvement in the quality of life for people with HCV. Are you ready for the challenge? You can make a difference—all you need to do is to make an effort and follow your heart.

Alan Franciscus is Executive Director of Hepatitis C Support Project, and publisher of the on-line newsletter, HCV Advocate.

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BROCHURES, EDUCATIONAL MATERIALS, TREATMENT INFORMATION ◆ Viral Hepatitis and HIV: The ABCs.AIDS Community Research Initiative of America (ACRIA). ◆ HIV/AIDS Clinical Trials: A Directory for NY State. 132 Clinical Trials; Includes NJ, Connecticut and Philadelphia. ACRIA .

AIDS Community Research Initiative of America (ACRIA): http://www.acria.org Tel: (212) 924-3934 ext. 129 ◆ Hepatitis C: Choices 2nd Edition . Edited

by Lorren Sandt and Tina M. St. John, M.D. Hepatitis C Caring Ambassadors Program. 389 pp. 2002.

Hepatitis C Caring Ambassadors Program: http://www.hepcchallenge.org/ Tel: (877) 737-HEPC (Toll free) ◆ Research & Policy Recommendations for Hepatitis C Virus (HCV)/HIV Coinfection: Critical Issues from TAG’s forthcoming HCV/HIV Coinfection Report, version 2.0.

February 2003. Tracy Swan.

Treatment Action Group: http://www.aidsinfonyc.org/tag/coinf/hcvh ivresearch.html Email: tagnyc@msn.com ◆ Hand in Hand: The User Friendly Guide to HIV and Hepatitis C Co-infection.

Lillian Thiemann. Visionary Health Concepts.

Visionary Health Concepts: http://www.vhconcepts.com/edu_progs.htm Tel: (800) 491-2181 ◆ Hepatitis C Virus (HCV) and HCV/HIV Co-infection Handbook, Version IV. Jules Levin. National AIDS Treatment Advocacy Project (NATAP).

National AIDS Treatment Advocacy Project (NATAP): http://www.natap.org Tel: (212) 219-0106 ◆ A Guide to Understanding Clinical Trials and Medical Research in Hepatitis C. Emmet B. Keefe, M.D. and Lucinda Porter, R.N. Hepatitis C Support Project.

Hepatitis C Support Project : http://www.hcvadvocate.org

BOOKS ◆ The Hepatitis C Help Book: A Groundbreaking reatment T Program Combining Western and Eastern Medicine for Maximum Wellness and Healing.

Misha Cohen, O.M.D. and Robert Gish, M.D., with Kalia Doner. © 2001, St. Martin’s Press, New York, NY.

◆ Frontline Hepatitis Awareness http://frontline-hepatitis-awareness.com Tel: (206) 324-0873 ◆ Harm Reduction Coalition http://www.harmreduction.org/pamphlets/brochure_exchange.html Tel: (212) 213-6376

◆ Hepatitis C: An Australian Perspective.

Edited by Nick Crofts, Greg Dore and Stephen Locarni. © 2001, IP Communications, Melbourne, Australia.

◆ HCV/HIV Co-infection (AIDS Treatment and Data Network) http://www.atdn.org/hcv.html Tel: (212) 260-8868 / (800) 734-7104 (toll free, NYS only)

◆ The Hepatitis C Handbook.

Matthew Dolan and Iain M. Murray-Lyon, M.D. © 1999, North Atlantic Books, Berkeley, CA.

◆ Hepatitis C Harm Reduction Project http://www.hepcproject.org Tel: (212) 213-6376, x.33

◆ Living with Hepatitis C: A Survivor’ s Guide.Gregory Everson, M.D. and Hedy Weinberg. 3rd Edition, © 2002, Hatherleigh Press, New York, NY.

◆ Hepatitis C Veterans http://hepcvets.com ◆ HIVandHepatitis.com http://www.HIVandhepatitis.com

◆ Healing Hepatitis C with Modern Chinese ◆ Immunization Action Coalition Medicine.Qingcai Zhang, M.D. © 2000, http://www.immunize.org and Sino-Med Institute, New York, NY. http://www.hepprograms.org Tel: (651) 647-9009 VIDEOS ◆ Living with Hepatitis C(in English and Spanish) (Free) New York City Department of Health and Mental Hygiene Tel: (212) 227-6021 Email: kschlang@health.nyc.gov ◆ Traces of Blood($12) AIDS Council of South Australia Available from Harm Reduction Coalition Tel: (212) 213-6376

ADDITIONAL RESOURCES

◆ Centers for Disease Control and Prevention http://www.cdc.gov/ncidod/diseases/hepatitis/resource/materials.htm

Hepatitis C and Harm Reduction Reader produced with funds provided by Roche Pharmaceuticals

◆ National HCV Prison Coalition/Hepatitis C Awareness Project http://www.hcvinprison.org Tel: (541) 607-5725 ◆ National Institutes of Health Consensus Development Conference Statement, Management of Hepatitis C: 2002. http://consensus.nih.gov/cons/116/116cdc _intro.htm ◆ O.A.S.I.S. Clinic http://www.oasisclinic.org/ Tel: (510) 496-0189 / (800) 282-1777

◆ American Liver Foundation http://www.liverfoundation.org Tel: (800) 465-4837, National Hepatitis Hotline (888) 4HEP-ABC (443-7222)

This publication is distributed with the understanding that Harm Reduction Coalition is not engaged in rendering medical, legal or other professional services.

◆ Latino Organization For Liver Awareness (LOLA) http://www.lola-national.org/ Tel: (718) 892-8697, Toll Free: (888) 367-LOLA (5652)

◆ Veterans Affairs—National Hepatitis C Program http://www.va.gov/hepatitisc

For additional copies, comments and questions contact:

Harm Reduction Coalition 22 West 27th Street, 5th Floor New York, NY 10001 Phone: (212) 213-6376 Fax: (212) 213-6582 Email: hrc@harmreduction.org