Hep Summer 2018

A SMART+STRONG PUBLICATION SUMMER 2018 HEPMAG.COM

Alive and Kicking A son helps his mom get cured of hepatitis C

The Opioid Crisis Drives Hep C New cases increase with injection drug use

Cirrhosis After the Cure?

Understanding a new risk calculator

Eliminating HCV in Veterans A major milestone in the epidemic

Connie Dewbre

Got Ink? An estimated 3–5 million Americans are living with hepatitis C. Most don’t know it.

Get tested today.

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FROM THE EDITOR

Mother and Child Reunion

EDITOR-IN-CHIEF

ORIOL R. GUTIERREZ JR. MANAGING EDITOR DEPUTY EDITOR

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CONTENTS 3 FROM THE EDITOR The importance of getting educated about new hep C treatments

onnie Dewbre of Texas is a 72-year-old retired administrator at a youth prison. Now cured of hepatitis C virus (HCV), she overcame many health battles along the way, including nearly dying in 2006 of complications from living long term with hep C. For years after that near-death experience, Dewbre managed living with HCV by changing her diet as well as quitting alcohol and cigarettes. Those changes helped, but the virus continued to damage her liver.

In 2013, a hope emerged. Her son, Eric McNatt, a photographer in New York, found a website with information about new treatments for hep C that were a major improvement on the old regimens, which used interferon.

Dewbre had taken interferon in past attempts at getting cured of HCV, but she became very sick on the drug, as many people did, and had to stop using it. The new hep C therapies do not use interferon and have few side effects.

McNatt actually read about the new treatments on the Hep magazine website, HepMag.com. He convinced his mother to try getting cured of HCV again with the new drugs. Dewbre was cured in 2014 and remains in good health.

When we learned about how Dewbre got cured, we felt so humbled about her successful treatment that we just had to tell her story. We even asked McNatt to do us the honor of photographing his mom for this profile. We thank them both very much for sharing their journey with us. Go to page 8 to read more.

C

JENNIFER MORTON

The Centers for Disease Control and Prevention recommend that all baby boomers, those born between 1945 and 1965, get tested for hep C. Despite this federal guideline, this population isn't getting tested for the virus at the levels that would make a difference for public health. Go to page 6 to find out why.

Although older people are a major subset of all those living with HCV, new cases of the virus are increasingly being diagnosed among younger people, especially those who use injection drugs. The opioid crisis is now driving hep C. Go to page 6 to learn more about how.

As a result of the opioid crisis, our health care system in general is facing new challenges. Infectious disease doctors in particular may need to reconsider their basic roles as care providers.

In addition to treating the virus, experts are coming to the conclusion that infectious disease doctors may need to start treating addiction issues directly.

Go to page 4 for more information.

ORIOL R. GUTIERREZ JR. EDITOR-IN-CHIEF

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4 NEWS Opioid crisis challenges infectious disease doctors • Beware of “health benefit plans” • Veterans Affairs to eliminate hep C in its patients • Global health officials seek increase in hep C treatment

6 TREATMENT NEWS The opioid crisis drives hep C • Boomers get an F for hep C testing • Hep C drugs not tied to liver cancer • Will your cirrhosis regress?

8 PROFILE Connie Dewbre, a retiree in Texas, gets cured of hep C after her son, Eric McNatt, a photographer in New York, reads all about the new drugs at HepMag.com.

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NEWS

Opioid Crisis Challenges Infectious Disease Doctors As the opioid crisis continues to affect millions of people across the United States, infectious disease (ID) specialists may need to venture beyond treating infections like hepatitis C virus (HCV), HIV and endocarditis and begin treating the underlying addiction of many of their patients.

The Department of Health and Human Services (HHS) reports that in 2016, 11.5 million Americans misused prescription opioids. That year, 2.1 million people reported trying opioids for the first time and an additional 2.1 million reported symptoms of opioid use disorder.

Meanwhile, physicians in small towns and cities are reporting major upticks in cases of infectious diseases such as HIV, hep C and endocarditis (an infection of the heart chambers and valves) due to injection drug use. As a result, ID specialists

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may need to address substance use disorders among their patients.

In recent years, according to the Centers for Disease Control and Prevention (CDC), heroin use in the United States has increased by more than 60 percent, and currently one in 10 HIV diagnoses in this country are among people who inject drugs. The agency also estimated that around 34,000 new cases of HCV were diagnosed in 2015, with the largest increases among young people who use injection drugs in nonurban areas.

In fact, the opioid crisis has become so severe that some experts are calling for ID physicians to include treating patients’ underlying addiction among their usual responsibilities. However, doing so would require a major expansion in ID specialists’ duties.

Attention anyone with a preexisting condition: Keep an eye on Iowa.

Republicans there have just passed a health care law that dodges the requirements of the federal Affordable Care Act (ACA, or Obamacare).

The law allows the Iowa Farm Bureau to sell health care coverage that is not called “insurance”— instead, it is labeled as “health benefit plans.” As such, these plans don’t have to comply with state and federal regulations, such as those affecting people who have preexisting medical conditions.

In fact, the Iowa law states that benefit plans sponsored by a nonprofit agricultural organization will not be considered insurance.

Needless to say, these plans will not be sold on the Iowa ACA marketplace, which now includes only one insurance option—and that insurer says it will sue over the new law.

Remember that the big tax bill passed by Congress and the Trump administration did away with the penalty for not having health insurance. (Obamacare included the individual mandate that everyone must have health insurance or pay a fine. This meant that, theoretically, all regardAmericans, regard less of health status, would share health care costs.)

Advocates worry that the Iowa law and the end of the individual mandate are pretaking us back to the pre ACA days, when healthy people had substandard coverage and insurance companies discriminated against those who actually needed health insurance.

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Beware of “Health Benefit Plans”

Veterans Affairs to Eliminate Hep C in Veterans Officials from the DepartDepart ment of Veterans Affairs (VA) have announced that the agency is on track to eliminate hepatitis C virus (HCV) in all veterans willing and able to be treated by the end of 2018.

The announcement marks a major milestone in the nation’s fight against viral hepatitis and means that more than 125,000 veterans will have received lifesaving cures by October of this year.

In October 2014, the VA had over 146,000 veterans living with HCV under its care, a number that’s expected to drop to just 20,000 by October, thanks to the agency’s commitment to providing hep C treatment.

The announcement stands in stark contrast to news articles from just a few years back that bemoaned the fact that the government couldn’t afford to treat tens of thousands of U.S. veterans living with HCV, many of whom were infected during the Vietnam War. This was back when Sovaldi (sofosbuvir), Gilead’s 12-week hepatitis cure cost nearly $84,000 per patient and threatened to cripple the VA’s budget.

However, the VA is allowed by law to negotiate drug prices.

In addition, several other hep C cures—such as AbbVie’s Viekira Pak (dasabuvir/ombitasvir/ paritaprevir/ritonavir) and Merck’s Zepatier (elbasvir/ grazoprevir)—have been brought to market over the last few years, driving competition up and drug costs down. Now, the VA can effectively treat veterans at a cost of roughly $25,300 per individual.

The VA estimates that it will spend nearly $751.2 million on hep C treatment in 2018, slightly up from the $748.8 million it spent last year.

G Global Health Officials Seek IIncrease in Hep C Treatment An new report by the World Health Organization (WHO) shows that Org the number of people receiving hepatitis C virus (HCV) treatment hepa around the world increased from around 1 million in 2015 to 1.5 million in 2016.

However, global health officials are still urging nations to scale up their fight against the virus and argue that global access to cures remains uneven.

Titled “Progress Report on Access to Hepatitis C Treatment: Focus on Overcoming Barriers in Low- and Middle-Income Countries,” the report reviews the progress made in ramping up access to treatment in 23 such countries around the world.

The update shows that Egypt and Pakis tan accounted for about half of people who started hep C treatment in 2016. Australia, Brazil, China, France, Georgia,

Mongolia, Morocco, Rwanda and Spain have also made progress in the fight against the global HCV epidemic.

The WHO report also provides information from innovator and generic drug manufacturers and multiple health organizations working in the field of hepatitis.

It underlines the importance of government leadership around the world in scaling up treatment, especially in low- and middle-income nations, which account for nearly 38 percent of all people with a chronic HCV infection. The report also argues that more countries need to procure generic cures for their populations in order to achieve WHO’s 2030 target for hepatitis elimination.

It is currently estimated that 71 million people worldwide are living with hep C—and all need treatment.

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TREATMENT NEWS

BY BENJAMIN RYAN

The Opioid Crisis Drives Hep C The number 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), strongly suggesting 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 HCV transmits much more readily via this route.

Centers for Disease Control and Prevention (CDC) researchers analyzed data from reports to the agency of diagnoses of acute (new) cases of hep C. 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 period during which about 13,000 people were diagnosed with acute hep C. During this time, the annual rate of acute hep C diagnoses increased from 3 cases per 1 million people to 7 cases per 1 million.

Those between 18 and 29 years old saw the highest increases of key related measures during the study period: a respective fivefold, sevenfold and ninefold increase in the rates of acute hep C, admissions to substance use disorder facilities for heroin injection and admissions due to the injection of prescription opioids.

“The impact of this new wave of infections may not be felt immediately but could be devastating,” says study author Alice K. Asher, PhD, RN, a health scientist at the CDC’s Division of Viral Hepatitis. Asher promotes a harm-reduction-based response, advocating for the use of federal funds “under certain conditions” to support “certain services offered by syringe services programs.”

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Baby boomers do not appear to be getting the message about hepatitis C virus (HCV) testing. Although federal guidelines recommend that all those born between 1945 and 1965 be screened for the virus, a recent study estimated that only about 13 percent of the birth cohort has done so.

An estimated more than three quarters of those living with HCV in the United States are baby boomers.

Perhaps 1 in 30 members of this generation have the virus.

Researchers analyzed hep C testing patterns from the 2013 to 2015 National Health Interview Survey data among 85,000 members of four birth cohorts: those born before 1945, between 1945 and 1965, between 1966 and 1985, and after 1985.

The researchers found that in all birth cohorts, females were less likely to get tested for hep C than males. Among baby boomers and those born between 1966 and 1985, HCV testing rates were lower among Latinos and Blacks compared with whites.

The proportion of baby boomer survey respondents who said they had been tested for HCV ranged from 11.9 percent in 2013 to 12.8 percent in 2015. Less than one in five of the baby boomers who got tested for the virus reported that they were prompted to do so because they were born between 1945 and 1965.

“Screening and treating baby boomers is a critical step toward reducing the burden of disease caused by untreated HCV infection,” says the study’s lead author, Susan T. Vadaparampil, PhD, MPH, of the Moffitt Cancer Center in Tampa, Florida. “Getting more providers to be aware of and comfortable with routinely screening baby boomers is critical. It’s also important for our public health community to educate baby boomers to know about and ask for HCV screening.”

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Boomers Get an F for Hep C Testing

Hep C Drugs Not Tied to Liver Cancer Contrary to the findings of previous research, a new study has found that compared with receiving interferon-based treatment for hepatitis C virus (HCV), successful interferon-free direct-acting antiviral (DAA) therapy is not associated with an increased risk of developing liver cancer among people with cirrhosis.

Researchers analyzed data on 857 people with cirrhosis who were cured of hep C between 1997 and 2016, some with interferon, 32 percent with just DAAs. At first glance, it seemed that interferon-free DAA treatment was associated with a higher risk of developing liver cancer following being cured of hep C, specifically a 2.5-fold elevated risk compared with receiving interferon-based treatment.

According to the study’s lead author, Hamish Innes, PhD, an epidemiologist at Glasgow Caledonian University in Scotland, this elevated risk was driven not by the difference in hep C treatments but by

the fact that “people treated with the newest therapies were older and had more advanced liver disease—which in and of themselves are risk factors for liver cancer.”

Indeed, in their analysis, Innes and his colleagues found that factors other than treatment type were associated with an increased risk of a liver cancer diagnosis after a hep C cure, including being older, being white, having more severe liver disease, having low platelets and having been treated for hep C two or more previous times.

After the investigators adjusted the data to account for differences among the study cohort members according to those risk factors, they found no significant difference in the liver cancer diagnosis rate between those treated with and without interferon.

Will Your Cirrhosis Regress?

A new risk calculator can help predict whether those with decompensated cirrhosis (the more severe form of the advanced liver disease) will see their liver damage dial back after being cured of hepatitis C virus (HCV) with direct-acting antiviral (DAA) medications.

To develop the scoring system, researchers analyzed data on more than 500 people with advanced liver disease who were cured of hep C with Sovaldi (sofosbuvir)-based regimens in advanced clinical trials.

During up to 36 weeks of follow-up, 32 percent of those who started treatment with Child-Pugh Turcotte class B liver disease saw a reduction to class A, as did 12 percent of those who initially had class C. The Child-Pugh Turcotte classification system grades liver disease on a scale of increasing severity from A to C. Based on factors they found were associated with a lack of improvement in liver function, the study authors created a new scoring system they called BE3A (check it out at www.e3ascore.com) in which five factors were each assigned one point, including: not having encephalopathy (the loss of brain function driven by a compromised liver failing to remove toxins from the blood), not having ascites (the abnormal buildup of fluid in the abdomen), having a body mass index indicating a healthy body weight, having an ALT liver enzyme level higher than 60 international units per liter and having an albumin level higher than 3.5 grams per deciliter.

A score of 4 or 5 was associated with a 75 percent likelihood of improving to class A liver disease, while those with a score of 1 had just a 25 percent chance of such improvement. Having any score between 1 and 5 did not predict whether individuals would undergo a liver transplant or die during follow-up, but a score of 0 was associated with a 25 percent chance of either of those outcomes.

The study’s senior author, Michael P. Curry, MD, director of hepatology at Beth Israel Deaconess Medical Center in Boston, says he hopes use of the BE3A scoring system “will allow physicians to more accurately determine the ability of DAA therapy to reverse liver failure.

For example, this information can be useful in determining the timing of DAA therapy in patients listed for liver transplantation.”

hepmag.com SUMMER 2018 HEP 7

PROFILE

Connie Dewbre at home in Texas

Alive and Kicking A photographer helps his mom get cured of hep C after reading Hep magazine.

By Tim Murphy Photography by Eric McNatt

B

y the mid-2000s, Connie Dewbre was in her 60s

and had nearly died of complications from living long term with hepatitis C virus (HCV) as well as from the brutal interferon therapy she had used to try to cure it—in vain.

By that point, she was living off disability insurance. Her son, Eric McNatt, a photographer, had moved from New York City back to their hometown of Brownwood, Texas, to take care of her. She had given up booze and cigarettes and had taken up a liver-healthy Mediterranean diet. One doctor told her she had about five years to live.

But another doctor, a resident from New York, gave her a heads-up. “He said, ‘Don’t get discouraged—there are new drugs coming,’” remembers Dewbre, 72, a retired administrator at a youth prison. “He told me to watch the internet.

‘You’ll live to see this in your lifetime,’ he said. That was uplifting to hear when I was very depressed.”

Ultimately, that doctor was right. But first, Dewbre would have a long hard road to tread. Born in Brownwood, she went to college and lived for several years in Arizona,

where she got married before moving back home to take care of her parents and give birth to McNatt in 1971. While pregnant, she hemorrhaged and was given a lot of blood.

That’s how she figures she contracted HCV, which wasn’t even discovered until 1989.

In the ensuing years, she found that she was tired all the time but didn’t know why. A doctor told her he thought she had some kind of unidentifiable hepatitis. By 1990, she was so sick that she started breaking out in hives. “I went to a specialist in Austin, and he took one look at me and said, ‘You have hep C—I know it.’” He put her on interferon, the standard treatment at the time, known for its harsh side effects and low cure rates.

“It was hell,” Dewbre recalls. “I know now that I’m highly allergic to interferon. I’d lay in bed unable to move, curled up in a fetal position. My mother had to come take care of me.”

(Dewbre’s husband was working in another city.) “Thank God for Granny,” she says. “She’s still alive at 95.”

When that doctor told her she was cured, she moved to Waco to be with her husband and found work. Eventually,

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they divorced, and she moved back to Brownwood, where she became an administrator at the local youth prison. (“I’m tiny, and people would ask me how I handled those kids, but most of the young men there were very polite.”)

But in 2006, she was told that she still had HCV. She went

on interferon again but couldn’t take it and quit after a month.

Yet a year later, she made herself take it again after a doctor told her she had Stage 4 liver disease. “That’s when I almost died,” she recalls. “I’d been taking interferon for a week and kept getting weaker, almost comatose. My sister took me to the hospital in Fredericksburg, where they didn’t think I’d live through the night. It was the first time I’d seen my doctor cry. She said, ‘Connie, you’re going to a better place.’”

But, miraculously, she lived and woke up in the intensive care unit the next morning to find McNatt, who’d flown from New York, and her niece at her bedside. “You’re not supposed to be alive,” her niece said. “I dressed for a funeral!’”

Dehydrated from the interferon, Dewbre was in the ICU for eight days. After that, McNatt decided to stay in Texas and take care of her. “I think that stalled his career, but he wasn’t going to leave me with a home health aide,” she says.

In the ensuing years, Dewbre was unable to work and went back on disability.

That’s when she adopted the Mediterranean diet, which stresses vegetables, legumes and healthy oils and rules out red meat and fried foods, which do a number on the liver.

She also kicked alcohol and cigarettes.

“Instead, I ate sugar,” she laughs. “I’m no longer real tiny—just short!”

It was actually McNatt who, in 2013,

“I just felt so glad to be alive.

It was so important to have my son and mother to care for me.”

encouraged his mom to consider taking HCV treatment again after reading on the Hep magazine site, HepMag.com, that the new hep C drug Sovaldi (sofosbuvir) had just been approved by the Food and Drug Administration.

A few months later, on Valentine’s Day 2014, under the care of Brownwood’s Gary Butka, MD, Dewbre started taking Sovaldi and velpatasvir—now available in the combination regimen Epclusa—paid for by her Medicare.

Traumatized by her past experiences with interferon, Dewbre asked Butka what she should do if she got sick.

“He said, ‘Don’t worry, you’ll feel fine,’” she recalls. And she did—except when she ate sugar, which made her throw up. But one month later, she tested undetectable for HCV in her blood.

She felt fine throughout her treatment and even flew to Arizona to spend two weeks with friends she hadn’t been able to visit for 20 years because of her sickness. And she’s been hep C–free ever since.

Since then, Dewbre says, “I take care of my mother and do what I can to help people I went to high school with. We share books and meals, get together monthly. I try to do

things to make my life nice. I can walk— that’s a big one!”

“I also get out and drive,” she says. “I took my cat [17-year-old blue-eyed, whitecoated Petey] to the vet this morning when the sun was coming up, and I just felt so glad to be alive,” she says. “It was so important to have my son and mother to care for me.”

McNatt, 46, who is back working as a photographer in New York (he photographed his mom for this story) says, “I’m grateful that my mother and I have this extra time. So much of her life was dictated by her bad health. It caused her a lot of stress as a single mom. But she stuck it out and kept fighting, and she made it.”

Dewbre urges others facing HCV treatment not to be

afraid. “Work to make sure your insurance will cover it and make sure you have someone to hold your hand or talk to on the phone to remind you this is a great opportunity in your life. I had no idea how much energy and alertness hepatitis took away from me. I had to cut out a lot of things I enjoyed, like dancing.”

Not anymore. When her old Arizona friends visit her soon, they’ll be two-stepping at the annual Outlaws and Legends Music Festival in Abilene. “My story has a happy ending,” she notes. “I never really planned on living this long, and I’m really glad to be alive.” ■

hepmag.com SUMMER 2018 HEP 13

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