Hep Supplement Spring 2018

SPECIAL SUPPLEMENT ON HEPATITIS C A SMART+STRONG PUBLICATION SPRING 2018 HEPMAG.COM

Advocacy in Action Empowering the voices of people living with hep C

Ryan Clary

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FROM THE EDITOR

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CONTENTS 3 FROM THE EDITOR The importance of advocacy in the fight against hep C

ver a decade ago, Ryan Clary shifted his priorities for health policy advocacy to viral hepatitis. This new focus was an outgrowth of his experiences working at HIV-related nonprofit groups like Project Inform and the San Francisco AIDS Foundation.

Clary learned along the way that the population of people living with HIV in the United States also has high rates of viral hepatitis. About 25 percent of folks with HIV nationwide also have hepatitis C virus (HCV) and about 10 percent of HIV-positive people across the country also have hepatitis B virus (HBV).

Despite these high coinfection rates, there were scant resources to fight HCV and HBV compared with those to combat HIV. Although viral hepatitis awareness and funding have improved—due in part to Clary’s leadership as executive director of the National Viral Hepatitis Roundtable (NVHR)—much is left to be done.

His strategy for ending the HCV and HBV epidemics is to apply the grassroots tactics used by HIV advocates— such as empowering the voices of people living with HIV to communicate directly with their elected officials—to what has become one of the most urgent public health concerns in the United States.

To better address the needs of people living with hep B and hep C, NVHR has taken on the role of convener for U.S. advocacy efforts to end the viral hepatitis crisis. Of course, Clary sits at the helm of these ongoing efforts. He even sits on Hep’s advisory board. Go to page 8 for more about Clary, his NVHR work and how you can get involved in advocacy.

Awareness and funding continue to be

O

EDITOR-IN-CHIEF

major challenges when it comes to viral hepatitis advocacy. What they have in common is stigma. Advocates like Clary and others attribute restrictions to treatment access, for example, and other such obstacles to the unfair and negative beliefs associated with viral hepatitis.

This stigma often gets in the way of commonsense approaches to managing the viral hepatitis crisis. Layer on top the harsh realities of the growing opioid epidemic, especially the rising rates of injection drug use nationwide, and you have a recipe for disaster. Thankfully, many advocates are fighting back.

Studies have shown that hep C rates are increasing along with injection drug use. Therefore, efforts to curb injection drug use should lower hep C rates. To achieve this goal, advocates around the world are already successfully operating safe injection facilities. Go to page 4 to read more about related U.S. efforts.

ORIOL R. GUTIERREZ JR. EDITOR-IN-CHIEF

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4 NEWS Are hepatitis efforts in the U.S. lagging? • Rising rates of injection drug use mean rising rates of HCV • Philadelphia OKs safe injection facility • Using treatment as prevention to fight HCV

6 TREATMENT NEWS Does an early cure for HCV protect the liver? • At risk for fatty liver disease • Reducing hospital trips translates into cost savings • Addiction impedes HCV treatment

8 PROFILE Ryan Clary, executive director of the National Viral Hepatitis Roundtable, plays a major role in shaping the national conversation around viral hepatitis.

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NEWS

Is U.S. Lagging in Hepatitis Efforts?

More than 60 U.S. advocacy organizations have signed a letter urging President Trump and his administration to invest more money in hepatitis elimination—alleging that the country is lagging in its quest to end its hepatitis C virus (HCV) and hepatitis B virus (HBV) epidemics by 2030.

The letter specifically asks Trump to invest in the Department of Health and Human Services’ National Viral Hepatitis Action Plan and commit in both words and deeds to the elimination of HCV and HBV in the United States by 2030, which the World Health Organization originally established as a goal.

Nine countries—Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar— are currently on track to achieve this milestone; however, the United States, one of the richest countries in the world, is not among them. No

new resources have yet been allocated at the national level to combat viral liver disease in this country.

A recent budget report by the U.S. Centers for Disease Control and Prevention recommended that the government commit $308 million for fiscal year 2018 to meet the goals set by the National Viral Hepatitis Action Plan. However, the Division of Viral

Hepatitis’s current funding stands at only $34 million.

The letter also suggests establishing a coordinated elimination effort at the highest levels of the government; opening up access to harm reduction programs, such as syringe exchanges and medication-assisted treatment for opioid users; and improving insurance coverage for hepatitis care.

The rate of U.S. residents who inject opioids has risen in recent years in tandem with the rate of new cases of hepatitis C virus (HCV), suggesting that the former factor is driving the latter. The warning signs are particularly concerning among young people.

Injection drug use is also associated with HIV transmission, although hepatitis C transmits much more readily through this route.

Findings in the American Journal of Public Health analyzed data from the Centers for Disease Control and Prevention’s National Notifiable Disease Surveillance System, looking at diagnoses of acute cases of hep C (indicating a recent infection).

They also relied on the Substance Abuse and Mental Health Services Administration’s data on national admissions to substance use disorder treatment facilities.

The researchers looked at data from 2004 to 2014, a

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period during which a total of 12,953 people were diagnosed with acute hep C. This meant that the annual rate of acute hep C diagnoses increased from 3 to 7 cases per 1 million people.

That said, there was a 5.29-fold increase in such admissions during the study period, compared with just a 1.85fold rise for admissions of people who inject heroin.

Young people between 18 and 29 years old saw the highest increases in both the rate of heroin injection use and abuse of prescription opioids as well as the rate of acute HCV. The study authors concluded: “These findings strongly suggest that the national increase in acute HCV infection is related to the country’s opioid epidemic and associated increases in [injection drug use].”

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As Injection Drug Use Rises, So Does Hep C

Philadelphia OKs Safe Injection Facility Philadelphia is set to house the nation’s first safe injection facility, where people who use drugs can inject under medical supervision.

The city has the highest rate of opioid overdose deaths among large U.S. cities.

The move is aimed at reducing the number of opioid-related deaths in Philadelphia. Last year, an estimated 1,200 residents died of opioid overdoses, nearly four times higher than the city’s homicide rate. Officials did not provide a start date or location for the site but are planning to work with medical and nonprofit organizations to fund, open and operate at least one facility.

Facilities are open in Canada, Australia, Denmark, France, Germany and Norway. At the sites, drug users are provided clean needles to prevent the spread of diseases such as HIV and hepatitis C virus and are supervised by security teams and medical professionals with access to the opioid-reversing drug naloxone.

Some programs also steer users to treatment and other services.

The city’s decision faces legal hurdles. The Department of Justice has yet to weigh in on Seattle’s discussions about opening such a facility. Further, how the federal government will treat safe injection sites in the future—despite President Trump’s declaration that opioids are a nationwide public health emergency—remains to be seen.

“Treatment as Prevention” to Fight Hep C Expanding hepatitis C virus (HCV) treatment among Americans who inject drugs could significantly help to reduce new HCV infections in the United States—and could potentially eliminate the liver virus in at-risk populations in as little as 10 years, according to new research from Yale University published in The Lancet.

The strategy, known as “treatment as prevention,” or TaSP, hypothesizes that curing hep C among at-risk individuals can, in the long run, help put a major dent in new transmissions of the virus. While TaSP has proved highly effective in reducing the spread of HIV, few studies thus far have investigated its efficacy with regard to viral liver disease.

The researchers found that when hep C prevalence is higher than 85 percent in a population of people who inject drugs, treatment as prevention does not substantially reduce the spread of HCV. However, when a group’s baseline prevalence was 60 percent or lower, researchers discovered that treating 12 percent or more of individuals in the group was, in fact, effective at preventing new transmissions, with the potential to eliminate the virus completely in the group within 10 years.

Researchers also noted that assigning treatment randomly throughout the population (rather than targeting just those with the greatest number of injection partners) was the most effective strategy at preventing new transmissions of hep C. They concluded by stating that with sufficient expansion in treatment coverage among people who inject drugs, HCV treatment as prevention can, in fact, work. The study was funded by the National Institute on Drug Abuse.

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TREATMENT NEWS

BY BENJAMIN RYAN

An Early Cure Protects the Liver?

People who are cured of hepatitis C virus (HCV) when they have minimal or no liver fibrosis (scarring) have a very low rate of liverhealth problems during the subsequent three years.

Researchers analyzed data from Gilead Sciences regarding 1,444 people who had no more than minimal fibrosis and were cured of hep C by a regimen including one of the company’s HCV drugs, among them Sovaldi (sofosbuvir), Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/ velpatasvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir).

These individuals received liver-health screenings every 24 weeks after being cured of hep C. A total of 580 individuals completed the analysis and had the full 144 weeks of follow-up, 545 were still enrolled in follow-up at the time of Gilead’s report and 319 dropped out of followup before 144 weeks were up.

Only three people experienced a notable liver-related health problem during follow-up, including jaundice, ascites (the accumulation of protein-containing fluid in the abdomen) and hepatic encephalopathy (loss of brain function when the liver fails to filter toxins from the blood).

Six people died during the follow-up, but none died of liver-related causes. No one developed liver cancer.

According to the study’s lead author, Marc Bourlière, MD, head of the hepatology and gastroenterology department at the Hôpital Saint Joseph in Marseille, France, the study “nicely demonstrates” that among those with no or mild fibrosis, extensive follow-up after they are cured of hep C isn’t needed except for those with other health conditions associated with fibrosis, including being overweight and drinking alcohol.

“Overall, these results are excellent and reflect the benefit of HCV cure,” says Bourlière.

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Even after achieving a cure for hepatitis C virus (HCV), individuals may remain at high risk for developing non-alcoholic fatty liver disease (NAFLD, or fatty liver for short).

Investigators compared tests of liver health among 101 people before and after they were cured of hep C. The average age of the participants was 60, and they had an average body mass index, or BMI, of 28 (25 is overweight; 30 is obese). Nine out of 10 had diabetes.

Those in the post–hep C cure group saw a significant drop in their ALT and AST liver enzymes and liver fibrosis (scarring) severity. However, 48 percent showed evidence of steatosis, which is the buildup of fat in the liver and an indicator of fatty liver disease. Six percent of those with such fat buildup and none of those without had advanced fibrosis.

“Our findings do not specifically link NALFD to hepatitis C treatment or being cured of hepatitis C,” says the study’s lead author, Mazen Noureddin, MD, the director of the Cedars-Sinai Fatty Liver Program in Los Angeles. “But patients who have the risk factors for NAFLD– those who are diabetics and/or overweight—should be evaluated for the liver disease once they have completed treatment for hep C.”

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Cured of Hep C, at Risk of Fatty Liver

Reducing Hospital Costs

People with cirrhosis of the liver who receive treatment for hepatitis C virus (HCV) are much less likely to be hospitalized, a benefit that translates into considerable cost savings.

Researchers analyzed data regarding 278 people with hep C and cirrhosis who were patients at a San Diego health center, including 182 people who received treatment for the virus and 196 people who did not. All individuals were followed for at least six months and for a median period of about a year and a half.

Eighty-seven percent of those treated with directacting antiretrovirals (DAAs) during follow-up were cured, including a respective 88 percent, 86 percent and 57 percent of those with mild, moderate and severe cirrhosis.

During each cumulative 100 years of follow-up, there were a respective 29 and 10 hospitalizations among those in the untreated and treated groups, including a respective 12, 57 and 95 hospitalizations among those with mild, moderate and severe cirrhosis in the untreated

group and a respective 3, 20 and 97 hospitalizations among those with mild, moderate and severe cirrhosis in the treated group.

DAA treatment was associated with a 64 percent reduction in the rate of liver-related hospitalizations during followup, including a 75 percent and 65 reduction among those with mild and moderate cirrhosis, respectively.

The investigators estimated that DAA treatment was associated with an annual per person savings of $3,650 to $8,200 among the study population as a whole, including a savings of $1,200 to $4,600 among those with mild cirrhosis and $5,350 to $17,800 among those with moderate cirrhosis at the study’s outset.

“Our study highlights the importance of treating patients with cirrhosis prior to developing more advanced disease,” says the study’s lead author, Lucas Hill, PharmD, a pharmacist specialist in HIV and HCV at the University of California, San Diego Health System.

Addiction Specialists List Barriers to HCV Treatment Medical providers who care for those taking opioid agonist therapy (OAT) for addiction to drugs such as heroin and prescription painkillers, say numerous barriers impede the treatment of hepatitis C virus (HCV).

Researchers conducted a survey of some 200 health care providers practicing at clinics that provide OAT in various Western nations.

The respondents identified a number of health-care-systembased barriers, including a lack of funding for noninvasive liver disease testing, long wait times to see a hep C specialist, lack of funding for HCV medications and a required period of substance-use abstinence for access to treatment.

As for barriers in their own clinics, the clinicians identified the need for an off-site referral for a liver disease assessment and treatment, a lack of peer-support programs and a lack of case managers or coordinators to link patients to necessary health care options.

Patient-based barriers identified included patients’ difficulties in navigating the health care system, patients not making referral appointments and patients’ fear of side effects and lack of motivation to receive treatment.

“Medical providers [who work with people who inject drugs] need to learn how to diagnose and treat hepatitis C and motivate their patients in order to reduce HCV-related mortality,” says the study’s lead author, Sheldon Litwin, MD, vice chair of academics and research in the department of medicine at Greenville Health System in North Carolina.

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PROFILE

Ryan Clary has advocated for people living with hep C for more than a decade.

Advocacy in Action Ryan Clary, executive director of the National Viral Hepatitis Roundtable, sits at the helm of U.S. efforts to end the epidemic.

By Casey Halter Photography by Winni Wintermeyer

E

leven years ago, Ryan Clary, a longtime HIV/AIDS

advocate for the likes of Project Inform and the San Francisco AIDS Foundation, pivoted his professional focus to ending the hepatitis C virus (HCV) and hepatitis B virus (HBV) epidemics in the United States.

Clary, 48, is now the executive director of the National Viral Hepatitis Roundtable (NVHR), where he leads a small but determined staff of health policy experts across the country dedicated to pushing policymakers, public health officials, medical and health care providers and the media to more aggressively address the nation’s liver disease crisis.

“The need is so great, and the resources are so few,” says Clary. “I just felt that there was a real opportunity for me to bring the skills and experience that I had developed in HIV advocacy to try to make an impact.”

His strategy for ending the HCV and HBV epidemics is to

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apply the grassroots tactics he and other HIV advocates used to combat that crisis—like empowering the voices of people living with HIV to communicate directly with their elected officials—to what has become one of America’s most urgent public health concerns.

His work has played a major part in shaping the national conversation around viral hepatitis. Today, NVHR is at the forefront of U.S. advocacy efforts both to end viral hepatitis and to better address the needs of people living with hep B and C. Under Clary’s leadership, NVHR has become well known

for pressing top government officials to make good on the promise to end the hepatitis epidemic by 2030—a goal originally set by the World Health Organization.

“Not only are we not moving toward elimination—we’re barely even managing the epidemics,” Clary says, pointing

to recent statistics from the Centers for Disease Control and Prevention showing that the number of new reported hep C cases has nearly tripled over the past five years. “It’s so poorly funded that we’re going backward.”

In an attempt to keep the government on course, NVHR hosts regular hepatitis action days on Capitol Hill for liver disease advocates to share their concerns. The group also lobbies lawmakers year-round to step up their hepatitis elimination efforts on behalf of their constituents.

NVHR recently joined 60 other advocacy organizations in sending a letter to President Trump directly, urging him to allocate hundreds of millions of dollars for hepatitis elimination.

“Our biggest challenge this year will continue to be protecting the health care system and the safety net,” Clary says. “We could get a massive infusion of hepatitis-specific funding, but if there is no health care safety net, then it won’t matter.”

With this concern in its sights, NVHR joined thousands of other health care and policy organizations nationwide to fight the Republican-led proposal to repeal the Affordable Care Act—a move advocates estimated would have potentially left nearly 32 million people uninsured, while imperiling the health of nearly 5 million Americans living with hep B or C. NVHR is also engaged in an ongoing fight to peel back Medicaid and insurance restrictions on new direct-acting antiviral treatments for HCV, a battle Clary says he’s been waging since cures were first introduced to the market in 2013.

“Stigma is huge,” says Clary. “I feel like stigma is one of the key drivers of the restrictions to treatment access that a lot of Medicaid programs have put in place. So that’s also one of our top policy priorities.”

To shed light on these restrictions, the group collaborated with Harvard Law School’s Center for Health Law and Policy Innovation to produce a report grading the Medicaid programs of all 50 states on HCV treatment accessibility.

The report showed that more than half of state Medicaid programs continue to impose discriminatory restrictions on hep C cures—such as requiring individuals with hep C to meet severe liver damage criteria or abstain from substance use for six months before they can access treatment.

It’s a policy battle NVHR will fight until all hep C treatment restrictions are revoked nationwide—and one that the group appears to be winning state by state.

at the lack of response to their health needs. That is going to lead to a lot of change.”

Part of this work revolves around hepatitis education. To that end, NVHR regularly hosts webinars for patients and providers that cover topics such as hep C considerations among pregnant women and the realities of living with viral hepatitis today.

From these grassroots discussions spring targeted actions.

One such recent example is the initiative “Hepatitis C—It’s About More Than Liver Disease,” which aims to raise awareness about HCV-related health conditions that occur outside the liver, such as kidney disease, depression, skin problems and lymphoma.

The end goal, says Clary, is not only to bring greater medical attention to patients with secondary medical issues but also to help make a stronger case for why liver disease patients should be granted access to early-stage treatment.

There’s also NVHR’s grant-building and research work, which helps fund and coordinate hepatitis and harm reduction advocacy groups across the country to expand their efforts on the ground. This includes giving seven $10,000 mini grants to U.S. community-based organizations to expand hep C education and increase testing and linkage to care in their local communities and disseminate those best practices nationally.

NVHR is working on a far-reaching pilot project this year with Seattle’s Peoples Harm Reduction Alliance, the Atlanta Harm Reduction Coalition and the Urban Survivors Union in North Carolina to help address increasing HCV rates among people who inject drugs.

“We’re looking for gaps in testing, gaps in access to treatment and gaps in prevention,” Clary explains. “NVHR’s role is serving as a convener. We help write the grant and get it funded, and then we provide mechanisms for our partners to communicate and share strategies and lessons learned.”

“NVHR’s role is serving as a convener.

We’re proud to be joining in partnership with an overall social justice movement.”

Further, Clary points out that NVHR isn’t just dedicated

to top-level political advocacy. Under the Californian’s leadership, the group is also devoted to community organizing and draws from his experience with the on-the-ground work that helped mitigate the impact of the HIV epidemic.

“I’m a firm believer that the people who are most impacted by any issue should be leading the advocacy efforts around that issue,” says Clary. “What we’re seeing is a growing movement among people living with hep C who are angry

As for what’s in store for NVHR in 2018, Clary says the

organization will continue to push for expanding hep C prevention, testing and treatment access, while also joining other health care advocates to protect the nation’s fragile health care infrastructure.

The group will also continue to ramp up its advocacy on behalf of at-risk and underserved communities, such as people of color, injection drug users and prison inmates—all of whom are at the heart of the crisis and are often overlooked.

“Any policies that are furthering the potential for more health disparities and discrimination—they’re going to have an impact on our ability to ensure that we’re addressing hepatitis C meaningfully in this country,” says Clary.

“We’re proud to be joining in partnership with an overall social justice movement to improve the lives of the communities we serve.” Go to NVHR.org to learn how to get involved. ■

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