HEP Fall 2014 by Smart + Strong

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

YOUR GUIDE TO HEPATITIS

True Grit

Lucinda Porter fought her own battle with hep C and is now helping others do the same.

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Hepatitis 101

Read the real-life stories of people living with hepatitis C at blogs.hepmag.com.

Find out what you need to know about hepatitis A, B and C. Learn the facts about transmission, testing and treatment as well as prevention.

Overheard in the Forums

The co-founder of The Bonnie Morgan Foundation shares her experiences with hep C.

Rick Nash

A hepatitis C advocate chronicles his fourth round of treatment for the virus.

Conference Updates Read the latest treatment news and highlights from conferences around the world including the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London.

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Check out the Hep Forums, a round-the-clock discussion area for people who have questions about hepatitis and liver health. Scroll through recent posts or join the conversation yourself.

Fewer Side Effects? Read our exclusive report to discover what kinds of side effects remain in the new, interferon-free treatments for hepatitis C and what you can do to remedy them.

How to Find Support Visit the Hep Health Services Directory (directory.hepmag.com), a comprehensive guide to hepatitis care and services featuring organizations nationwide including drug treatment centers, clinics and hepatitis testing centers.

(BLOGGERS) COURTESY OF BLOGGERS; (VIRUS) AP PHOTO; (LONDON, MAN, COMPUTER) THINKSTOCK

The Strive 2 Thrive founder blogs about living with three Hs: hepatitis C, HIV and hemophilia.

Kim Bossley

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Joe Burke

Just wondering how everyone feels physically after becoming undetectable? Have not started treatment yet, but I will soon. I’m hoping that all of these body aches subside. Not sure what I’m really supposed to feel like after having this for 19 years.

FROM THE EDITOR

EYE OF THE TIGER CONTENTS 3 FROM THE EDITOR Overcoming obstacles to survive and thrive

(COVER) TOBY BURDITT; (GUTIERREZ) JOAN LOBIS BROWN

4 TREATMENT NEWS Sovaldi-ledipasvir pill safe with major HIV meds • “3D” cures 99 percent to 100 percent of genotype 1b • daclatasvir and asunaprevir cure up to 87 percent of 1b • primary care docs are clueless about hep C drugs • major health benefits of hep C suppression • curing hep C lowers central nervous system fatigue 6 FEATURE Hep Hero: How Lucinda Porter beat hepatitis C and ended up helping others fight it, too.

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“It all comes down to survival!” So goes the 1982 song “Eye of the Tiger” by the U.S. rock band Survivor. The theme song from the movie Rocky III is over-the-top cheesy, but it did succeed in conveying the fighting spirit of the film. It held the No. 1 spot on Billboard’s Hot 100 chart for six weeks, so it’s not too much of a stretch to say that folks nationwide at least found the song catchy and perhaps inspiring. Although the fun of finding such inspiration in cheesy places can be uplifting, it’s more often the case that inspiration is found in less flashy places. Counterintuitively, those places can even include dark places, if you’re willing to do the work to find the light again and then apply the lessons you learned while in the dark. Such was the journey for Lucinda Porter, who graces the cover of this issue. Now cured of the hepatitis C virus (HCV), she went through many struggles to accomplish that goal. Not only did she endure going through unsuccessful treatments using the older medications before being cured by the latest hep C meds, but Porter also battled severe depression both before and after becoming HCV positive. Along the way—and well before she was cured of hep C—Porter says she “had an epiphany” that led to her eventual wellness and even advocacy. As a result, Porter is an inspiration not just for people living with HCV, but for all people who face health challenges (in other words, all of us). Go to page 6 to read more about Porter (as well as her love of organic food and the TV show Mad Men). Just as Porter and countless others have already benefitted from the new hep C meds, the potential for up to millions of Americans to also benefit makes this one of the most exciting moments in modern medicine. Taking the best advantage of this time, however, will require your getting educated on the new treatments, as well as working with your health care providers to figure out the best treatment options for you. Go to page 4 to get a start on learning about the latest news on hep C treatments. For daily updates and in-depth lessons on hepatitis transmission, testing and treatment, as well as prevention, go to hepmag.com. You’ll also read real-life stories of people living with HCV, and you’ll find support in the forums. 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 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

Gilead Sciences’ fixed-dose combination pill of Sovaldi (sofosbuvir) and the investigational ledipasvir, likely to receive FDA approval on October 10, does not significantly interfere with five common HIV antiretrovirals. virals. Gilead conducted three trials rials to look for drug-drug interactions ractions between the combination tion hep C treatment and Isentress ntress (raltegravir), Atripla ipla (efavirenz/emtricitaitabine/tenofovir) and nd Complera (rilpivirine/ rine/ emtricitabine/tenofovir). ofovir). The researchers found und no dose adjustments were required for pairing those HIV meds or Truvada (tenofovir/emtricitabine) b ) with Sovaldi-ledipasvir. The investigators found that Atripla lowered levels of ledipasvir by about 30 percent and that Sovaldi-ledipasvir lowered Isentress levels by less than 20

percent. However, they determined that neither of these effects was clinically relevant. Sovaldi and ledipasvir raised tenofovir levels about 1.8 to 2.6fold when w the HIV drug was in Atripla and 1.3 to 1.9-fold when it was in 1.9 Complera. NevertheCo less, the researchers conless cluded clude that the tenofovir dose ne needed no adjusting. Andrew Andr H. Talal, MD, a hepatologist hepa at State University of New York at Buffalo, called the study results “very good news for patients. And for the clinicians, it makes it substantially easier to t h i n k ab out t r e at i ng c oi n fe c te d patients, and it potentially opens the possibility for new physicians to treat patients they wouldn’t otherwise be willing to treat.”

“3D” Cures 99% to 100% of Genotype 1b AbbVie’s so-called “3D” combo regimen ditched ribavirin and still cured 99 percent to 100 percent of study participants with genotype 1b of hepatitis C virus (HCV) in two recent Phase III trials. The 3D regimen includes a fixed-dose combination of ABT-450 and ritonavir coformulated with ombitasvir (ABT-267) as well as dasabuvir (ABT-333) and is given with or without ribavirin. The FDA is expected to issue a decision about the drug’s approval by the end of the year. Ninety-one members of the PEARL-II trial, who had all failed a previous attempt at a cure, and 209 members of the PEARL-III trial, who were all being treated for the first time, took 3D for 12 weeks with no ribavirin. In the two trials, a respective 100 percent and 99 percent of the participants were cured. Considering that these cure rates were similar to the rates for those who did take ribavirin with the 3D regimen, the researchers concluded ribavirin made no difference in treatment outcomes. David Bernstein, MD, chief of the division of hepatology at North Shore University Hospital in Manhasset, New York, said that, if approved, 3D will add “another very good regimen for a specific pecific patient population. It’s a very well-tolerated d regimen. And I think the more regimens ns we have out there—the more choices— — the better it’s going to be for patients and practitioners.”

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Daclatasvir and Asunaprevir Cure Up to 87% of 1b Failing to boast results as stellar as the competition, Bristol-Myers Squibb’s daclatasvir and asunaprevir cured a respectable 81 percent to 87 percent of people with genotype 1b of hepatitis C in a recent Phase III trial. The FDA is likely to approve the combination therapy by year’s end. A total of 135 people who were ineligible to take interferon or intolerant of the drug, along with 87 others who had not responded to a previous attempt at a cure, took daclatasvir once daily and asunaprevir twice daily for 24 weeks. A total of 87 percent of the first group and 81 percent of the second were cured. Cure rates among those who had cirrhosis and those who did not were similar: At 91 percent and 84 percent, respectively, the success rates weren’t statistically significant, meaning the difference could have occurred by chance. Douglas Dieterich, MD, a professor of medicine at Mount Sinai School of Medicine in New York City, made a “wild guess” that BMS would price daclatasvir and asunaprevir lower than the competition and that people with hep C might be inclined to take the BMS regimen over Gilead or AbbVie’s offerings “if your o pharmacy pharma co-pay is 50 percent for one and zero for the other.” o

ALL IMAGES: THINKSTOCK

Sovaldi-Ledipasvir Pill Safe With Major HIV Meds

Primary Care Docs Clueless About Hep C Drugs About three out of four primary care physicians (PCPs) are unfamiliar with the new generation of hep C drugs: Janssen’s Olysio (simeprevir) and Gilead Sciences’ Sovaldi (sofosbuvir), which each received U.S. Food and Drug Administration (FDA) approval at the end of 2013. The private health care research firm Decision Resources Group learned this when polling 100 PCPs, 44 gastroenterologists and 7 hepatologists for a report on how new medications will impact the role of PCPs in caring for people with hepatitis C virus (HCV). More than half of the specialists polled said they were comfortable with having PCPs prescribe all-oral, interferon-free hep C regimens to patients who have minimal liver damage. But about a third of the PCPs said they anticipated always referring such patients to a specialist. Decision Resources Group analyst Hannah E. Cummings, PhD, remarked, “Given that PCPs are well positioned to recognize patients at high risk of acquiring HCV infection, it will be essential to engage in continued efforts to educate PCPs on HCV-related risk factors and increase their familiarity with currently recommended HCV treatment regimens.”

ALL IMAGES: THINKSTOCK

Hep C Suppression Linked to Major Health Benefits Suppressing the hep C viral load— which is a precursor, although not necessarily a perfect predictor, of successful treatment—is associated with a diminished risk of liver disease and death. Researchers studied a sample of almost 29,000 people with hep C drawn from a Veterans Affairs database that includes medical records from 1999 onward. About a quarter of the sample had undergone treatment for the virus, with 16 percent achieving an undetectable viral load. The researchers found that fully suppressing hep C lowered the risk of death by 45 percent and also lowered by 27 percent the combined risk of cirrhosis, decompensated cirrhosis, liver cancer and liver-related hospital admission.

While this study only looked at those treated with interferon and did not predict the benefits of an actual cure, the paper’s lead author, Jeffrey McCombs, PhD, an associate professor at the University of Southern California, says, “The very good news is that the newer medications that are coming out are much more tolerable. The world in the future looks much better.”

Want more info Tekay? Check out www.poz.com for more information

Curing Hep C Lowers Central Nervous System Fatigue Ridding the body of hep C reduces central fatigue, which is weakness originating in the central nervous system. Researchers looked at changes in fatigue levels in 413 people with hep C following successful treatments based on Sovaldi (sofosbuvir). Responses to questionnaires showed that, if the study participants had achieved a sustained virologic response 12 weeks after completing therapy (considered a cure), they experienced an average 27 percent improvement in measures of vitality, 20 percent improvement in fatigue and 11 percent improvement on what’s known as an activity-energy scale. All of nine points in a questionnaire measuring central fatigue showed improvement. Study lead Zobair Younossi, MD, MPH, executive director for the Center for Liver Diseases at Inova Fairfax Medical Campus in Virginia, noted that 40 to 50 percent of people with hep C experience chronic fatigue. He said that cures “will potentially lead to better quality of life, but also better worker productivity.”

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CREDIT TK HERE

FEATURE

How one woman overcame hepatitis C and ended up helping others fight it, too. By Tim Murphy Photography by Toby Burditt

ucinda Porter is an inspiration and a lifeline to countless Americans living with hepatitis C virus (HCV). Not only did this 61-year-old nurse from Grass Valley, California, overcome her own hep C ordeal, but she also went on to become an expert and author in the field and a source of information and guidance for many of her hep-infected peers. “I’m so devoted to this issue, and it takes up the majority of my life,” says Porter, who is a contributing editor at Hep and also a key member of the Hepatitis C Support Project in her region. “I can’t imagine I’ll ever do anything other than this work.” But she had quite the journey getting there. Born in Connecticut, Porter struggled with severe depression from an early age and was hospitalized for it several times, often using

alcohol to self-medicate. Despite those struggles, she went to Syracuse University, earning a degree in women’s studies. “Then I did what every good feminist in the mid-1970s did,” she laughs. “I became a high-voltage electrician.” She also moved to California, got married, had a daughter and then became a doula, someone who provides assistance and support to women before, during or after childbirth. But depression still plagued her—almost fatally. In 1988, in despair, she attempted suicide with a gigantic dose of Tylenol— 10 times the dose considered toxic to her liver, which went into failure. Doctors saved her with a blood transfusion. Once recuperated, she went to a 12-step program to overcome the alcohol use she’d relied on for years to numb her depression. She also recommitted to therapy. “I had an epiphany,” she says. “I realized

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I couldn’t even kill myself, so I was going to have to start to live. Something greater than me was saying there’s a reason for you to be alive, even though I didn’t know what it was.” But she took a step: With her husband’s support, she went to nursing school, earning her degree a few years later. But two months after her lifesaving hospital transfusion, she found herself chronically exhausted. “Then I started to turn yellow,” she recalls, “and they ran some tests, finding elevated liver enzymes.” Her doctors told her they thought that she’d contracted a non-A, non-B form of hepatitis from the transfusion. (It was right before researchers discovered the hepatitis C virus in 1989.) “The doctors told me to go home, don’t worry about it, no big deal, have a lovely life. Which I did, until, in nursing school, they started talking about hepatitis C. I’d previously not given my own hepatitis a thought. But one of my first patients in nursing school was a 35-year-old woman with hep C and alcoholic cirrhosis. I watched her die and I thought, I don’t think this is a benign problem after all.” By this point, 1995, Porter returned to the doctor and asked for the test to detect hep C that had come out three years earlier. Sure enough, she had it. But she did not freak out. “Once you’ve been close to death, you tend to take news pretty well,” she says. Porter underwent interferon treatment. “It wasn’t fun,” she recalls. “I was quite depressed”—depression being a common side-effect of interferon—and that was

exchange in 1997. “Every client there had hep C,” she recalls. “I could see we had a problem and it was bigger than anything talked about on the Internet,” which was still in its infancy as a popular information medium. Shortly after, Porter was among those who started a regional Hep C Task Force.

he then joined with Alan Franciscus to start the Hep C Support Project. At a conference they organized for health care providers and hep C patients, Porter was offered a job in Stanford University’s new liver disease department. She ended up working there until 2008, almost exclusively with hep C patients in studies. “I would teach them how to administer their meds and handle their side effects,” she says. “It was a wonderful job.” But there was still the matter of her own uncleared hep C. In 2003, she did 48 weeks of treatment with pegylated interferon and ribavirin, which caused her agitation and anemia as well as lightheadedness and fatigue. “But when the going gets tough, I get obstinate,” Porter says. She continued to work and travel and speak nationally, plus make herself walk a couple times a day. Short naps throughout the day, an antidepressant and her support group really helped. “You realize that everyone

“WHEN THE GOING GETS TOUGH, I GET OBSTINATE.” scary because I hadn’t been depressed in a while.” She also had extreme fatigue, no appetite and very itchy skin. And, like many hep C patients at that time, she did not clear the virus. (In the past year or so, treatment outcomes have improved dramatically, as have the treatments themselves.)

ut something good came out of the experience. “It spurred me into thinking there should be a support group for patients going through this—and there was no such group in my area,” Porter says. “And that’s what got me into hep C activism.” With another nurse, she started a support group. At the same time, she read about a man named Joey Tranchina who’d started an illegal needle exchange nearby to prevent HIV and hep C among injection drug users. “He had gotten arrested, and I thought that was appalling.” After the jury acquitted Tranchina, Porter contacted him and ended up working at the needle

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else is going through what you are,” she says. “When you put it out in the open and laugh about it together, you don’t get scared. It’s gallows humor!” Though her hep C viral load went to undetectable while she was on the treatment, it rebounded once she stopped. Once again, treatment had failed to clear her virus. “I was still proud of myself for trying,” she says. The experience inspired her to write a book about every aspect of living with and treating the virus, Free From Hepatitis C, published in 2011. (She followed it up in 2013 with Hepatitis C Treatment One Step at a Time—and she’s working on another book, about getting through health problems in general.) Finally, last year, Porter joined a clinical trial at Stanford and was put into a group getting 12 weeks of ribavirin plus the then-experimental drugs sofosbuvir (now on the market as Sovaldi) and ledipasvir (the drugmaker Gilead has recently applied to the FDA to market a pill coformulated with Sovaldi and ledispasvir). She cleared the virus by the fourth week, with her viral load plummeting from 8 million to a mere 52 in

the first week alone. Side-effects-wise, says Porter, “I wouldn’t call it a walk in the park, but with no interferon in the mix, it was my easiest treatment so far.” Porter has been hep C-free ever since. But if you think that means she’s walking away from hep C advocacy, think again. In addition to her ongoing work for Hep magazine and the Hep C Support Project, she’s still intensely involved in online forums on Hep’s website, Facebook and elsewhere. “My life is heavily hepped,” she jokes. “If there were a psychiatric designation for someone who is clearly a hepaholic, I’d be it.” Nothing will stop her from telling everyone she meets about hep C. “I play my own version of Six Degrees of Kevin Bacon,” she says, referring to the game in which you try to link celebrities to their connection with the Footloose star, in as few degrees as possible. “I see how soon can I start directing nearly any conversation to hep C,” she says, “because our medical establishment has done a very poor job of screening people for it, especially baby boomers.” They are at risk because they often had transfusions before blood started being screened for the virus in the early ’90s. “We should be screening anyone at risk for hep C, including anyone born from 1945 to 1965,” she says, echoing regulations from the Centers for Disease Control and Prevention (CDC). Lucinda Porter’s experience with hep C inspired her to write books on the topic and to support other’s on the journey.

She also wants to see action on the Viral Hepatitis Testing Act of 2013, which would greatly expand hep C surveillance, awareness, testing and linkage to care. “It’s hung up in Congress,” she laments. “Meanwhile, lots of doctors are reluctant to even test patients because they can’t connect them to care, since many states are not advancing affordable health care. But,” she says, “you can at least do antibody testing and confirm that people don’t have hep C.” Porter has clear and compassionate advice for those just finding out they have hep C: • Don’t be scared, because fear just makes it worse! Let go of the fear and start getting good info and support. Visit hepmag.com for more information. • Find a good doctor. Search the American Liver Foundation website at liverfoundation.org or call 800-GO-LIVER (800-465-4837). • Don’t drink alcohol! “New drugs are coming out this fall,” Porter says. “They’re worth waiting for. Few people have to be treated immediately, so start by sitting down and learning your options. And know that, despite the appallingly high prices of the new drugs, the drugmakers really are trying to help with patient assistance programs.”

elieve it or not, Porter finds time for a few things other than hep C advocacy. She jazzercises daily and does strength training three times a week. She and her husband travel frequently and are committed to eating local, organic food. “We just made a quinoa dish with black beans, avocado, cilantro, tomatoes and olive oil on a bed of baby kale, and it was delicious!” she raves. She also loves the TV show Mad Men. The secretaryturned-copychief Peggy Olson is her favorite character. “She encapsulates what it’s like to be a female in a male profession,” says Porter, who was once the only female electrician among a crew of men. “They’d try to make me uncomfortable, grabbing my breast and putting snakes and bugs in my lunchbox,” she recalls. “I had to be twice as good as the guys.” Today, Porter has put that gumption into her mission to take shame out of the hep C equation. “One of the most painful parts of having the disease is the stigma,” she says. “It’s important that we tell our stories and put a face on it to fight that. People say it’s a drug users’ disease, which horrifies me because it stigmatizes drug users and gets us stuck in the wrong conversation. I hope we can get past how people got hep C and focus more on what we’re going to do about it.” ■

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