HEP Winter 2015

Page 1



Tuned In To Treatment


Pop star and activist Sherri Lewis sings out against hep C



DAY BY DAY CONTENTS 3 FROM THE EDITOR The importance of taking things day by day when facing hepatitis C 4 HEP NEWS A hep C treatment for all genotypes • six-week treatment? • HIV no longer holds down cure rates for hepatitis C • HCV hurts the heart • insurance woes


6 PROFILE Singer and activist Sherri Lewis tunes in to her hep C treatment.

For more information on hepatitis, go to


Patience is indeed a virtue. That doesn’t mean having patience is easy, but it does mean that striving to have patience is a worthy goal. It’s also a task that needs frequent repeating, since losing patience is all too easy. When it comes to your health, however, it may seem counterintuitive to strive for patience. After all, if you’re sick, shouldn’t you want to get better as soon as possible? The answer to that is yes, of course, generally speaking. But sometimes it pays to have patience with choosing and taking your treatment. Sherri Lewis was patient with her hepatitis C treatment. She waited, and waited, and waited. She wanted new, easier-to-take options with low side effects and high cure rates in only weeks instead of many months. She got what she wanted. The singer and activist finally got her hep C undetectable. As of press time, we can’t officially use the word “cured” to describe where Sherri is in her hep C journey. Current guidelines say that you have to test undetectable 12 weeks after treatment to declare you’re cured. Go to page 6 to read her story and then go to hepmag.com for her final test results. Hep C isn’t the only virus of serious concern in Sherri’s life. She also lives with HIV. Hep C is common among people living with HIV. In the United States, up to 30 percent of HIV-positive people are estimated to also have hep C. Either virus alone is a threat to your health, but combined they are a formidable force. There are effective treatments that can make HIV undetectable in tests, but that doesn’t mean you’re cured of the virus. Thankfully, there is a cure for hep C. For all people with hep C, getting cured is easier than ever. For those with hep C and HIV, getting cured of hep C is also more realistic. In fact, a new study shows that HIV no longer holds down cure rates for hep C. Go to page 4 to read more about that study and other hep C treatment updates, including information on a new option for all hep C genotypes, a potential six-week treatment and more.


Published by Smart + Strong, publishers of Hep and Hepmag.com. Copyright © 2015 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 Deputy Editor: Trenton Straube Contributing Editor: Lucinda Porter Copy Editor: Meave Gallagher 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

hepmag.com WINTER 2015 HEP 3


A Hep C Treatment for All Genotypes Gilead Sciences appears poised to continue its dominance of the hepatitis C treatment market in 2016 after achieving excellent results from several large Phase III studies of a new regimen that treats all genotypes of the virus. The four studies looked at a once-daily, singletablet combination of Sovaldi (sofosbuvir) and the investigational drug velpatasvir for the treatment of genotypes 1 through 6 of hep C. In October, Gilead filed for U.S. Food and Drug Administration approval of the combination regimen. Three of the studies included a cumulative 1,035 people with genotypes 1 through 6 of hep C, who were all treated with Sovaldi/ velpatasvir for 12 weeks, with or without ribavirin. A fifth of the participants had compensated cirrhosis, and just over a quarter had failed a previous cure attempt. A fourth study included 267 individuals of all genotypes, all of whom had decompensated cirrhosis. Some of them took ribavirin in addition to Sovaldi/velpatasvir. When breaking down the results according to ribavirin use and genotype, in most cases the regimens cured 94 to 100 percent of the participants. Participants with decompensated cirrhosis who did not take ribavirin saw cure rates in only the mid-80 percent range. However, among those with such advanced liver damage who added ribavirin, 94 percent were cured. The most common side effects of Sovaldi/velpatasvir were headache, fatigue and nausea, as well as anemia among those also taking ribavirin. Blaire E. Burman, MD, a hepatologist at the Virginia Mason Medical Center in Seattle, touts this treatment

as good news for global treatment of hep C. “In areas of the world with limited health care resources, where the majority of HCV-infected persons live, determining the genotype of the hepatitis C virus is often not feasible, and thus the availability of a single pill that is effective for all genotypes is truly a gamechanger,” she says.

A Phase II trial of Achillion’s investigational hep C treatment odalasvir (ACH-3102) and Gilead Sciences’ Sovaldi (sofosbuvir) has shown show promise that a six-week hepatitis hep C treatment may be on the horizon. The study included people with genotype 1 of the virus who had not been treated

4 HEP WINTER 2015 hepmag.com

before. All 24 of the participants who took the regimen for six weeks were cured. The treatment proved well tolerated. Kris Kowdley, MD, a liver specialist at Swedish Medical Center in Seattle, says, “This regimen seems promising, and we would be interested in seeing more data”—in particular to more precisely determine how short of a treatment length will provide good results.


Six-Week Treatment?

HIV No Longer Holds Down Hep C Cure Rates Recent trials of the current crop of hepatitis C virus (HCV) medications have brought more good news for those who are coinfected with HCV and HIV, showing hep C cure rates comparably high to those seen in studies including people who only have HCV. In one study, Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) cured hep C in 96 percent of 335 coinfected participants. AbbVie’s Viekira Pak (ombitasvir/ paritaprevir/ritonavir; dasabuvir) cured 92 percent of 63 coinfected people in another trial. In a study of Bristol-Myers Squibb’s Daklinza (daclatasvir) and Gilead’s Sovaldi (sofosbuvir), 97 percent of the coinfected participants were cured. The hep C regimen did not negatively affect HIV treatment.

As of press time, Merck was expecting to receive word in January 2016 from the U.S. Food and Drug Administration about its application for approval of the single-tablet HCV treatment grazoprevir/elbasvir. A recent study saw a 95 percent cure rate among 218 coinfected people who hadn’t received hep C treatment before. Hailing all of these study results as great news for those coinfected with HIV and HCV, Daniel Fierer, MD, an infectious disease specialist at Mount Sinai Hospital in New York City, says the next major goal is an effective regimen, like Gilead’s Sovaldi/velpatasivr, that effectively battles all six major genotypes of hep C. (Recent studies of that investigational combo did not include those coinfected with HIV, however.)


Hep C Hurts the Heart Hepatitis C is apparently independently linked with plaque buildup in the arteries, which can lead to heart attacks and strokes. Out of the 994 men whose medical data researchers analyzed, 613 were HIV-positive, 70 were coinfected with HIV and HCV, and 17 had only hep C. After adjusting the data for various factors, the scientists found that the individuals who had hep C, regardless of HIV status, were 29 percent more likely to have coronary artery calcium, 26 percent more likely to have any plaque buildup and 42 percent more likely to have noncalcified plaque. Additionally, those with hep C viral loads over 2 million were more likely to have plaque buildup

than those who did not have hep C.

 The study’s senior investigator, Eric Seaberg, PhD, an assistant professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, says that people with hep C should pay attention to their overall risk of cardiovascular disease. He recommends they “discuss their cardiovascular health with their physician while getting an annual cardiac checkup that includes cholesterol and glucose testing, a blood pressure assessment, and an examination of lifestyle habits.” Getting a hep C viral load test done at least once, he suggests, could be helpful for assessing overall risk.

Insurance Woes The benefits of screening for hep C are diminished in individuals who test positive and do not have health insurance. To come to this conclusion, researchers analyzed data on 38,000 people who were tested for hep C as a part of the National Health and Nutrition Examination Survey between 2001 and 2010.

 Participants in the study who received a positive test result were sent a letter informing them they had hep C, along with advice to seek a medical consultation. They were also given information about the transmission of hep C and the potential complications of living with the virus. Six months later, researchers contacted the participants to see what sort of action, if any, they had taken in response. 

 A total of 502 participants tested positive for hep C, with 205 of them participating in the six-month follow-up interview. Half of these individuals had not known they were HCV positive before undergoing the test. A total of 166 of those interviewed (81 percent) had sought further medical evaluation within six months of testing positive.

 Researchers found that the only significant barrier to seeking further HCV-related care was a lack of health insurance. Uninsured people were 2.76 times less likely to seek further care than those who had health insurance. “It will be up to physicians and patients to draw our lawmaker’s attention about barriers to accessing treatments that can prevent the downstream highcost complications of HCV,” says Savita Srivastava, MD, spokesperson for the American Gastroenterological Association, from the University of Virginia and University Physicians Group.

hepmag.com WINTER 2015 HEP 5



ALIVE Singer and activist Sherri Lewis tunes in to hep C treatment. By Tim Murphy Photography by Andrew McLeod

he first thing you notice about performer and activist Sherri Lewis is her laugh—a wonderful cackle that usually follows one of her hilarious, self-deprecating remarks about her topsy-turvy six decades of life. But on this October day in Los Angeles, where Lewis has lived since 1999, the laugh is full of pure joy. The reason? It’s the last day of her three months of taking Harvoni, a daily pill to treat the hepatitis C virus (HCV) she’s been living with since she was 17, and now her hep C is undetectable. “It’s a pretty historic day for me,” she announces. “Of course, I have to be checked again in another 12 weeks to make sure I’m still undetectable and considered cured, according to my doctor.” That would be Judith Currier, MD,

MPH, who has been treating Lewis since shortly after she was diagnosed with HIV in 1987. “We’ve been walking this path together for a long time,” Lewis says of herself and Currier. “We’re like a Lifetime TV girly movie!” And then comes that great laugh. Lewis lived a long time with both HIV and hep C. Among the many lessons of her life, which in the ’80s included the highs of showbiz and the lows of addiction, is the fact that you can live with both viruses if you work with a doctor and take care of yourself—especially today, Sherri Lewis in an age where HIV has long been treatcelebrates in Los Angeles able and hep C is more easily cured than after learning ever. (Lewis has good reason to have high that her hep C is undetectable. hopes for her 12-week follow-up; 96 percent

hepmag.com WINTER 2015 HEP 7

of Harvoni takers who also had HIV were still hep C undetectable, hence considered cured, at the 12-weeks-aftertreatment mark.) The road to today for Lewis has been a long one. She grew

up in a comfortable New Jersey suburb, singing and dancing professionally in New York City on TV shows for children, and managed by her dad, who sold women’s accessories out of his office in the Empire State Building. “He’d say, ‘If I can sell a handbag, I can sell talent,’” Lewis recalls. “And he was right.” From an early age, Lewis knew she had the stuff to make it big—an exuberant stage presence and a terrific voice. “I took my work seriously even as a kid,” she says. “No one ever told me, ‘Stick to your day job.’” But her early 1970s Jersey adolescence also was troubled, marked by the breakup of her parents’ marriage and also sexual abuse by someone close to her. In her teens, seeking solace from the pain, she was briefly introduced to injecting heroin. Of course, none of that stopped Lewis. At 18, she moved to New York City to study acting, joined a Ukrainian dance troupe and lived in the East Village, Sherri Lewis then one of the city’s most dangerous looks forward neighborhoods. to performing again without “You never found your car the way you to worry left it,” she remembers, laughing. “Once a having about hep C. knife was pulled on me, but thankfully nothing happened.” Was she scared? “I had nothing to compare it to except Jersey, which I hated,” she laughs. “I was a pop kid, so I started making my way to clubs,” like the legendary rock hangout Max’s Kansas City, where Lou Reed got turned on to her stage presence. Soon enough, she was in an all-girl punk band called Mande Dahl. “We had songs like ‘Kitchen Bitch’ and ‘Glands Out of Control,’” Lewis recalls with a fond chuckle. “I wore Barbie-doll plastic earrings.” But shadowing her fun was bad health news. As early as 17, “I felt terrible,” Lewis recalls. “I was falling asleep all the time, burping a lot with a really rotten-egg taste to it.” A doctor tested her liver and told her she had hep C—or what was then called non-A, non-B hepatitis. (Hep C wasn’t discovered until 1989.) “I must have gotten it from my early experimenting with needles,” Lewis assumes. “The doctor said, ‘You can die from this, so you can’t drink.’” She didn’t drink for a while, but then she did again. Then came marijuana and the ’80s. Lewis and her new boyfriend, Zecca Esquibel, started a band called Get Wet that caught the attention of legendary disco producer Neil Bogart, who was looking to shift to pop. “He said to us, ‘We’re going to make you the next big thing’ and brought in Phil Ramone to produce us.” The result was the doo wop-sounding “Just So Lonely,” which in 1981 made it to No. 39 on the Billboard chart and got the duo a spot on American Bandstand. With her good looks, bright voice and vintage petticoat style, Lewis was poised to become a pop darling à la Madonna or Cyndi Lauper. But then came cocaine. “It was the ’80s, and everyone thought it wasn’t addictive,” laughs Lewis. “I didn’t have to buy it. It was brought to us in the recording studio, 8 HEP WINTER 2015 hepmag.com

mountains of it, cocaine and champagne.” Then, while on a promo tour in Europe, the white powder she requested turned out to be heroin. “A little sniff here and there, and I was knocked out.” It was all downhill from there. Lewis and Esquibel broke

up amid tension that the producers wanted her as a solo act, which Lewis says made her “so paranoid” she couldn’t act on it, choosing instead to be bought out of her contract for $5,000 and playing small local gigs. “I got lifted out of a lot of cakes at Gay Prides by muscle boys,” she laughs. But by 1983, she was completely addicted to heroin and living in the dark in her West Village apartment because she wasn’t paying the rent or electricity. She abandoned the apartment, sold everything she had and went to the East Village, “copping drugs and hanging out in abandoned buildings and luncheonettes.” Eventually hitting rock bottom, she “crawled into a detox,” which led her to nine months in a Roman Catholic state institution in New Jersey. “I left there shell-shocked,” Lewis recalls. Thus began her slow climb back to sobriety and recovery, attending 12-step meetings on St. Marks Place in the East Village and working at the boutique of the iconic pop-punk fashion designer Betsey Johnson. A year later, a friend introduced her to a Boston musician. “He was so cool, salt-and-pepper hair, everything was perfect.” The two got engaged. “I thought, oh my God, I’m going to have kids!” But all around Lewis, longtime gay friends and fellow recovering injection drug users were getting sick with a new disease called AIDS. She got really scared when a female friend contracted it. “I saw her with wasting and dementia.

That alarmed me even though I felt perfectly healthy. I was the queen of aerobics by then.” When she visited a doctor in a Boston suburb to get a blood test for her marriage license, she also requested an HIV test. “He said to me, ‘Don’t worry about that, nobody tests HIV positive here, this is Massachusetts.’” Turns out, the first HIV test the doctor ever gave—to Lewis, on April 12, 1987, her 33rd birthday and three months before her wedding day, with the invitations already in the mail—was positive. (Lewis believes she got HIV sexually, but she’s not completely sure.) “Thank God I had the 12-step program,” recalls Lewis of learning that news, “because I knew how to pray. I dropped to my knees, and it’s a miracle that I didn’t pick up drugs again.” Happily, her fiancé tested negative. And though he was devastated to learn Lewis had HIV, the two still married and spent seven years together, though Lewis admits that her HIV diagnosis killed their sexual spark. “I felt too uncomfortable in my skin.” (They remain good friends, though, as do she and Esquibel, who’s still in the downtown New York arts and music scene.) During those Boston years, she also began seeing a therapist, whom she continued to see for the next 12 years, until she moved to Los Angeles. “My therapist once said to me, ‘I thought I was going to help you die,’” she recalls, “‘but all you ever wanted to talk about was life.’” And Lewis now had a fierce will to

time for Lewis to take the plunge and get into a Harvoni study. But then they hit a snag: Pre-treatment testing showed that she had some kidney problems, which she and Currier attributed to Lewis’s several years on Truvada, an HIV drug that in studies has been linked to kidney damage. Lewis first had to switch to a new HIV regimen. Lewis finally started her 12-week course of Harvoni this summer. “I had a little nausea and headache the first month only, so I took it with oatmeal,” she says. “But I actually kept thinking, I can’t believe they came up with a hep C drug where you can take it and function. It’s not like the older drugs, where people really suffered. It’s amazing, even though it’s expensive.” Harvoni costs about $1,125 per daily pill, or $94,500 for 12 weeks of treatment. “But it’s cheaper than treating liver cancer or having a liver replacement,” Lewis continues. “I’ve seen people die from hepatitis, and once my HIV was under control a long time, it still scared me that my hep C was untreated for so long.”

“I didn’t want my mother to bury her child. I can see how what I’m doing now is the right thing.”

live. She worked for several years as a counselor and speaker for the Harvard AIDS Institute. She then found a similar job at the University of California, Los Angeles. After effective treatment for HIV came along in 1996, she finally went on it in 1998 and has been on it ever since. She has never had a major complication from HIV. She credits following a macrobiotic diet, along with her 12-step meetings, social network and hot yoga, with keeping her healthy all these years. But there was that pesky matter of hep C. For years, Lewis was adamant that she would not go on any of the existing therapies with their harsh side effects, such as nausea, exhaustion and depression. Then, in late 2014, the U.S. Food and Drug Administration (FDA) approved Harvoni. The med, which contains the direct-acting antivirals sofosbuvir and ledipasvir, along with the FDA approval of Sovaldi (sofosbuvir) in late 2013, signaled a major breakthrough in hep C treatment. The new drugs achieved unprecedentedly high cure rates with none of the old side effects. At that time, Lewis had stage 3 fibrosis, meaning that her liver damage was advancing. Lewis and Currier, her longtime doc, agreed it was finally

She has strong advice for other folks

considering going on hep C treatment: “Go for it. You’ve got to push to get it covered. My co-pay alone was $3,000. Since I also have HIV, ADAP [the AIDS Drug Assistance Program, a federal/state payment program via the Ryan White CARE Act] picked up my co-pays—what a blessing.” (She also has received help paying for her insurance plan from AIDS Project Los Angeles.) With her hep C now undetectable, Lewis is doing what she does best— thinking about how to get the most out of her life. She’s been caring for her elderly mother, whom she moved to a care facility in Los Angeles so they could see each other daily. “I didn’t want my mother to bury her child,” she says proudly. “I can see how what I’m doing now is the right thing.” But what Lewis really wants to get back to is what she has done best since she was a little girl, which is performing. “I need to be singing!” she exclaims. In April, she did a fundraiser for Project Angel Food, which delivers meals to folks in Los Angeles homebound with HIV/AIDS or other disabilities. She brought down the house with a heart-stirring rendition of Stephen Sondheim’s “Being Alive,” preceded by her tale of learning she had HIV in 1987. She’d also like to write a memoir. “This story hasn’t been told,” she says. “A hetero Jewish white girl pop singer who had an actual moment with celebrity and success, then the downhill slide, then the success of staying alive and healthy right to this stage in life.” She does have one more goal. “Beating HIV,” she says. “That’s the next step.” Go to hepmag.com for an update on Lewis’s hep C journey.

hepmag.com WINTER 2015 HEP 9