Hep Summer 2014 by Smart + Strong

SPECIAL SUPPLEMENT ON HEPATITIS C A SMART+STRONG PUBLICATION SUMMER 2014 HEPMAG.COM

YOUR GUIDE TO HEPATITIS

Vocal Talent

Elizabeth Owens is a powerful advocate for hep C awareness and education.

FROM THE EDITOR

RESPECT YOURSELF CONTENTS 3 FROM THE EDITOR The future of hep C treatment looks promising

(COVER) BILL WADMAN; (GUTIERREZ) JOAN LOBIS BROWN

4 TREATMENT NEWS Gilead criticized for Sovaldi’s sky-high price • interferon-free treatment options abound in the hep C pipeline • baby boomers shoulder the hep C burden • a manifesto to fight viral hepatitis • no link between hep C and diabetes? 6 FEATURE Facing Fears: Elizabeth Owens was frightened when she learned she had hepatitis C, but advocacy and education are building up her courage.

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The journey from being diagnosed with the hepatitis C virus (HCV) to being a grassroots community activist wasn’t easy for Elizabeth Owens. Although she graces the cover of this issue, it took time to build up courage to face her fears of hep C. Through education on the virus, Owens has empowered herself to make informed treatment decisions. Through advocacy, she empowers other people living with HCV to do the same—and people at risk for the virus to stay HCV negative. Owens has not started hep C treatment herself in part because she distrusts the older regimens, which failed to help several of her friends. However, as a 54-year-old woman living with hep C in the midst of menopause, she is now at the time when her liver is more likely to develop fibrosis. As a result, she is slowly preparing herself to enter treatment, especially because the availability of newer regimens is increasing. They have lower side effects and higher cure rates. Read our feature story on her struggles and her journey of self-empowerment on page 6. In fact, the hep C treatment pipeline is starting to pick up at an increasing pace. Sovaldi (sofosbuvir) from Gilead Sciences and Olysio (simeprevir) from Janssen were approved by the U.S. Food and Drug Administration (FDA) at the end of 2013. Since then, sales of both drugs have skyrocketed. In particular, Sovaldi sales of more than $2 billion during the first three months of 2014 have broken the sales record for the entire first year of any drug. The effectiveness of Sovaldi and Olysio certainly has driven the sales demand, but the high costs of the drugs have driven the profits. Advocates are seeking price reductions to increase access to the drugs for the people who need them the most. Further, advocates are concerned about how the high cost of these drugs will affect the pricing of promising hep C drugs coming to market in the near future. FDA approval of other hep C drugs and combos from Gilead, Janssen, Bristol-Myers Squibb and AbbVie may come by the end of 2014. Go to page 4 to read more on the pipeline, and go to page 5 to learn about updates to the federal action plan to fight viral hepatitis.

ORIOL R. GUTIERREZ JR. EDITOR-IN-CHIEF HEPMAG.COM FACEBOOK.COM/HEPMAG TWITTER.COM/HEPATITISMAG

Published by Smart + Strong, publishers of Hep and Hepmag.com. Copyright © 2014 CDM Publishing, LLC. All rights reserved. No part of this publication may be reproduced, stored or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the written permission of the publisher. Send feedback to HEP c/o Smart + Strong, 462 Seventh Avenue, 19th Floor, New York, NY 10018. Tel: 212.242.2163.

Editor-in-Chief: Oriol R. Gutierrez Jr. Managing Editor: Jennifer Morton Senior Editor: Kate Ferguson Editor-at-Large: Benjamin Ryan Copy Editor: Trenton Straube Art Director: Mark Robinson Production Manager: Michael Halliday

SMART + STRONG President: Ian E. Anderson EVP and Publisher: Susan S. Levey Integrated Advertising Coordinator: Jonathan Gaskell

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TREATMENT NEWS

A California medical panel has lambasted Gilead Sciences for its exorbitant, $1,000-a-pill pricing of Sovaldi, which adds up to $84,000 for a typical 12week course. In March, the California Technology Assessment Forum brought together medical experts from around the state to weigh in on the new hep C meds. The group has asserted that Sovaldi and the Janssen drug Olysio are likely superior to the older treatment options, but that the new drugs represent a “low value.” Consequently, the medical experts asserted that only those with more advanced liver disease but without major complications should undergo treatment with Sovaldi or Olysio at this time. The forum estimated that supplanting older hep C therapies with Sovaldi would yield an extra $18 billion to $29 billion in annual costs for both government and private insurers.

The era of interferonfree HCV treatment regimens began with Gilead’s Sovaldi.

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Just a few years ago, treatment options were bleak for people living with hepatitis C virus (HCV)—especially those with advanced liver disease, who most urgently need a cure. Attempting to rid the body of the virus meant rolling dice loaded with dreary odds for success and spending a year suffering through flu-like side effects from the dreaded weekly injectable drug interferon. In 2011, the first pair of direct-acting antivirals (DAAs) to treat hep C were released. These drugs upped cure rates and lowered treatment times, although they still had to be taken with interferon. Then, at the end of 2013, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences’ Sovaldi (sofosbuvir) and Janssen’s Olysio (simeprevir), two DAAs that have kick-started a revolution in hep C care that will only accelerate during the coming year or two. “This is a time when spectacular results in curing HCV are the norm,” said Douglas T. Dieterich, MD, a professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City. “In addition, these treatments require a shorter duration of therapy and often have less toxicity.” Current guidelines typically recommend 12 to 24 weeks of treatment with Sovaldi, interferon and the drug ribavirin. This offers an 85 percent to 95 percent chance of a cure in most cases. Those with genotype 1 of the virus who are ineligible to take interferon—which some clinicians argue includes those who simply do not want to take the drug—may opt for 12 weeks of Olysio, Sovaldi and ribavirin or 24 weeks of Sovaldi and ribavirin. There is also good news for those who are coinfected with hep C and HIV. Not only is Sovaldi the first DAA specifically approved for use in coinfected people, but recent research also shows that this population’s chances of a cure are no different than those without HIV. Also, in most cases Sovaldi can be paired safely with HIV meds. Thanks to the pent-up demand for treatment and Sovaldi’s $84,000 price tag for 12 weeks of therapy, Gilead made $2.3 billion in sales during the first three months of 2014, about $2 billion of it in the United States. This obliterated the record for any drug’s entire first year on the market. By comparison, during the same period Janssen sold $354 million of Olysio, which costs $66,360 for 12 weeks. With so much at stake, a handful of pharmaceutical companies are locked in a competitive race to bring new combination therapies to market that will drive success rates into the 95 percent-plus range for most people, while further lowering treatment times and doing away with interferon for good, not to mention ribavi ribavirin, which can cause anemia, among other side effects. Between B February and May, Gilead, Janssen, Bristol-M Bristol-Myers Squibb and AbbVie all submitted applications to the FDA for new interferon-free hep C combination regihe mens. This means that in m a all likelihood the last few months of 2014 will produce more dramatic changes in the treatment landscape. Acc According to Daniel Fierer, MD, an assistant assista professor of medicine in infectious diseases, disease also at Mount Sinai, present treatment priority should be for those with cirrhosis; others should probably hold off for this more g golden opportunity. driv down prices as In addition, the resulting competition could drive companies try to chip away at Gilead’s supremacy, providing much-needed relief to overtaxed insurers, both public and privat private.

THINKSTOCK

Gilead Criticized for Sovaldi’s Sky-high Price

Interferon-free Treatment Options Abound in the Hep C Pipeline

Baby Boomers Shoulder the Hep C Burden Eighty-one percent of U.S. hepatitis C cases are among baby boomers, according to new prevalence estimates from the Centers for Disease Control and Prevention. CDC researchers examined data on 30,000 people who participated in a national health survey between 2003 and 2010. With 273 of the participants testing hep C positive, the investigators calculated that this equated to a U.S. prevalence rate of 1 percent overall. While the official CDC estimate may have dropped from 3.2 million to 2.7 million people as a result, the new estimate range is actually 2.2 million to 3.2 million people, which overlaps with the old one. The estimated 2.6 percent prevalence rate among baby boomers—those born between 1945 and 1965—is six times that of other adults.

(MAN) THINKSTOCK-IMAGE USED FOR ILLUSTRATIVE PURPOSES ONLY; (VIAL AND SYRINGE) ISTOCKPHOTO.COM/PLAINVIEW; (BULLHORN) THINKSTOCK

A Manifesto to Fight Viral Hepatitis In April, a consortium of federal agencies updated the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis, originally drafted in 2011. The plan set ambitious benchmarks for the decade’s end, including: upping the proportion of those who are aware of their hep B status from 33 percent to 66 percent and those who know their hep C status from 45 percent to 66 percent; cutting the number of new

hep C cases by a quarter; and wiping out mother-to-child transmission of hep B. Among the plan’s principal priorities are: improving the testing, care and treatment of viral hepatitis; preventing all hep A and B through vaccines; improving viral hepatitis surveillance; and cutting down on viral hepatitis transmitted through injection drug use.

No Link Between Hep C and Diabetes? New research has cast doubt on the presumed link between hep C and diabetes. Researchers analyzed population-based data on 15,000 adults participating in a national health survey between 1999 and 2010 and found that hep C status was not correlated to the prevalence of diabetes or prediabetes. There was also no apparent link between insulin resistance and hep C in those with normal glucose levels. The older papers that found a link between diabetes and hep C are arguably weaker because they were not built on population-based research. The authors behind the new study speculate that the supposed link between hep C and diabetes found in the more dated research may have been a consequence of elevated liver enzymes as opposed to the virus.

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FEATURE

FACING

FEARS Elizabeth Owens was frightened when she learned she had hepatitis C, but advocacy and education are building up her courage. By Kate Ferguson

BILL WADMAN

ome may say women living with hepatitis C are luckier than men with the liver disease. After all, studies show women are more likely than men to clear severe hepatitis C infection without undergoing treatment, and they’re less likely than men to develop hepatocellular carcinoma, a common liver cancer. What’s more, in women, hep C progresses more slowly to cirrhosis, a heavy buildup of scar tissue on the liver. Meanwhile, in the Bronx, New York, Elizabeth Owens is not feeling so lucky. In reality, her gender is currently working against her health. Now age 54, Owens is in the midst of menopause, and for women living with the hepatitis C virus (HCV), that’s precisely when the liver disease is more likely to progress to fibrosis, which is the first stage of liver scarring.

As an older woman, Owens also falls into the female age group of those who are less responsive to the meds interferon and ribavirin, two elements of traditional hep C treatment (more on this in a moment). Indeed, Owens says she distrusts these drugs because they failed to help several of her friends living with hep C. “I watched and saw that these medicines weren’t helping them at all,” Owens says. “I’ve buried seven people. I went to their services, and I was with them until the bitter end.” Thankfully, Owens’s observations are increasingly a thing of the past. Newer treatments—including Sovaldi (sofosbuvir) and Olysio (simeprevir)—boast cure rates over 90 percent, and they rely less on ribavirin and interferon, which is notorious for its flu-like symptoms. And even newer meds and combos are in the treatment pipeline.

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This is good news for the nearly 3.2 million people who, according to the Centers for Disease and Control Prevention, are chronically infected with HCV in the United States. Hepatitis C is a liver disease that is transmitted when the virus of an infected person enters the bloodstream of a negative person. This happens most commonly through injection drug use, needlesticks, tattoos, piercings and childbirth, as well as blood transfusions and organ transplants before 1992, when sensitive screening tests for hep C were developed. In rare cases, it can also be transmitted sexually.

wens is candid about how she contracted hep C. She used heroin for years. “I kept hearing about hepatitis C, because I had a lot of friends who passed away from the condition,” she says. But like many people with undiagnosed HCV, she didn’t notice any unusual symptoms so didn’t get tested. “At the time, I was still doing drugs and I was running around all over the place,” she recalls. “I’m a workaholic, so if I noticed that I was getting tired, I’d tell myself to rest for a couple of days. Then I’d get back up and start going again.”

When Owens stopped using heroin, her life changed. She became a volunteer at the New York Harm Reduction Educators (NYHRE), a grassroots, social justice advocacy organization in New York City that works with people who use drugs or live in other desperate circumstances. Owens was familiar with NYHRE. It’s where she got clean syringes back in her drug days. This time around, the nonprofit agency provided her a more constructive purpose. She learned how to communicate and reach out to other people. The majority of people Owens interacted with were black and Latino. “I got tired of seeing them walking around with scabs, or spots, on their limbs,” she recalls. “I cared about their health and talked to them so they’d know there were places to get care.” Soon, Owens found herself doing outreach work and dispensing health information along with syringes. She found a lot of love in the work. “I hug people,” she says. “I’m the type to hug you and let you know that we’re here together and we’re going to beat this thing.” This type of work, she says, “teaches you not to judge somebody for what they are.” One day, a group from VOCAL-NY arrived at NYHRE to talk about advocacy. Owens listened to them discuss how politics works and how to use the political system to improve people’s lives in their communities. “I got so interested in it

OWENS DOESN’T HESITATE TO ASK QUESTIONS ABOUT HEP C AND HER HEALTH. Still, doubts and curiosity nagged at her. While at a drug treatment center that offered physicals and medical checkups, she decided to ask the doctors to test her for the disease. The results were positive. The diagnosis devastated Owens. She was especially frightened because she didn’t know anything about the disease. So she asked questions of people she knew were suffering from the illness and on treatment. Their stories fueled her fear of treatment even more. “As far as treatment was concerned, I noticed there were no dependable doctors that you could go to for treatment for anything,” Owens says. “In my neighborhood, I didn’t think any of those health professionals was reliable enough to be my doctor. They couldn’t answer my questions about the disease and how it affected African Americans like they could for [people of] other races.” So Owens faked left to go right. Instead of seeking treatment for hep C, she signed up to kick her heroin habit at the drug treatment center she’d been visiting. Since she wasn’t comfortable with the hep C expertise in her community, she preferred to address the destabilizing effects of drugs.

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because I noticed that they didn’t discriminate against a drug user and they told us that advocacy could work,” she says. “All of a sudden, I found myself being involved and bringing my energy to VOCAL-NY.”

ased in Brooklyn, VOCAL-NY (Voices of Community Activists and Leaders) is a grassroots group dedicated to helping low-income people battle issues such as HIV, incarceration, poverty and hepatitis. As Owens immersed herself in trainings about HCV, she realized how little she actually knew about the disease. It also dawned on her that with certain diseases, such as HIV, delaying treatment may in fact be harmful. This disconnect, Owens says, was the main reason she became a peer educator. “I started learning more about how to stay healthy, how to pass out information to others who were drug users so I could help stop the spread of hepatitis C and HIV.” Currently, Owens chooses not to begin hep C treatment.

Her reasons are simple: Doctors scare her and she lacks confidence in the health care system. “I want to find a responsible doctor that I can start treatment with and go all the way to the end,” she says. “When I go to a doctor, I have to build trust. I want to feel comfortable because I’m putting my life in that person’s hands. I don’t want someone talking to me like they’re trying to discipline me, telling me to do this and do that [without explaining things].” Owens isn’t the only one who’s afraid. A support group she formed is peopled by other women living with hep C who share her fear of doctors and the medical establishment. But many people with hepatitis C, for one reason or another, delay going into treatment. Some may never develop a major complication from the illness; others aren’t faced with life-threatening liver disease; and yet others are holding out for better treatments. Fortunately for Owens, her health is currently good. But most experts agree that if hep C remains untreated, the condition is more likely to develop into liver cancer.

BILL WADMAN

Elizabeth Owens (second from left) with Matt Curtis, the policy director at VOCAL-NY, and two program directors from the Washington Heights CORNER Project (WHCP), which collaborates with VOCAL-NY.

s an organizer at VOCAL-NY’s GROW (Grassroots Organizing to Win), Owens advocates on behalf of people who often don’t feel they have a voice. “I like to say I give people back their life and I let them know that they do have a right to say something,” she says. “My payment is when somebody comes up and hugs me and says, ‘Yo, I didn’t know that I could go up there and sit in a congressman’s office or an assemblyman’s office and they’d listen to me tell them what’s going on in the neighborhood.’” During the two and a half years she’s been at VOCAL-NY, Owens underwent a personal transformation that is ongoing. “What I did is rebuild my whole system of living,” she says. “I had to get someplace safe to live, have a foundation so I could pay my rent, be able to cook and just be relaxed. And then I changed my diet.” Previously, Owens would eat just once a day and quaff 40 ounces of beer. Now she cooks her own meals in lieu of buying store-bought prepared foods. “I even make my own jellies and chicken and dumplings and gumbo, all that stuff,” she says. Fresh fruit is also on the menu nowadays, and she drinks water and juices. “If I do have a drink, everything has to be light,” she says. (But, experts warn that even small amounts of alcohol can accelerate the onset of liver disease.) At home, Owens gets emotional nourishment from her female friendship group. When they get together for a night or for the weekend or for a “women’s day,” no cell phones are allowed. “It’s called a ‘strength party,’” she explains. “That’s where we build each other up and everything is strictly

confidential and we all get in the kitchen and cook something.” But for Owens and company, these strength parties offer much needed support in other areas of their lives. As a former drug user now living with hep C, she’s often exposed to the sting of stigma, she says, from a source many may find surprising. “Once doctors find out that you’re an ex-drug user, they don’t want to give you any information,” Owens complains. “Many of them just think you want to get something so you can go get high with it, especially if you’re an AfricanAmerican woman.” In her South Bronx neighborhood, Owens says, doctors are hard to find, so she’s ventured to “different places to help me with my health.” As an activist and organizer, Owens is boldly outspoken. The same holds true in her personal life; she doesn’t hesitate to ask medical practitioners questions about hep C and her health. “When I go to the doctor with my book of notes to ask some questions,” she says, “I feel like the nurse or doctor should be equipped to reply back to me, not say, ‘Well, we’ll find out the next time you visit.’” Experiences like this have kept Owens from starting hep C meds. But as she negotiates her ambivalence about doctors, she’s slowly preparing herself to enter treatment. “Now, I’m getting more courage,” she says. “Me and the women I meet with on the weekends, we’re going to try the buddy system to help me shop for a woman doctor to visit.” And so Owens’s transformation continues. She has taken control of her health and is moving in a more positive direction. Along the way, she’s helping others by advocating for their health. Adds Owens in her characteristic big, booming voice: “Because of stigma, the doors have always been closed in my face by the system. But I’m making a difference now.” ■

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