HEP Fall 2015

SPECIAL SUPPLEMENT ON HEPATITIS C A SMART+STRONG PUBLICATION FALL 2015 HEPMAG.COM

YOUR GUIDE TO HEPATITIS

Sheila Dewey

Model of Fitness

Practicing yoga and other wellness tips can keep you healthy before and during treatment

FROM THE EDITOR

I FEEL GOOD CONTENTS 3 FROM THE EDITOR Getting and staying healthy with hep C

(COVER) WINNI WINTERMEYER; (GUTIERREZ) JOAN LOBIS BROWN

4 HEP NEWS Daklinza approved for genotype 3 • Technivie approved for genotype 4 • excellent cure rates achieved in difficult-totreat cases • the race is on to shorten treatment length • injection drug use fuels outbreaks 6 PROFILE Yoga enthusiast and mother of six Sheila Dewey shares how to get and stay healthy before, during and after hep C treatment

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Yoga is much more than twisting yourself into a pretzel. The practice is primarily for meditation, not physical fitness. Quieting the mind is the ultimate goal, but undeniably the practice can be used for fitness alone. The poses are meant to enhance your inner peace, but it’s also true that they can make you strong and flexible as they clear your head.

Whether for physical fitness or mental health, or ideally both, practicing yoga is increasingly being embraced across the country by people from all walks of life. That is especially so for those who are seeking to improve their overall wellness, which should be your goal if you’re living with hepatitis C virus (HCV).

Getting and staying healthy before, during and after HCV treatment is vital for your wellness. Getting as healthy as you can prior to treatment gives you more options. Staying as healthy as possible during and after treatment solidifies the benefits you’ve gained.

Practicing yoga and following wellness tips can make a real difference.

Such was the case for our cover gal, Sheila Dewey, a yoga enthusiast and mother of six. In 2014, Dewey was among the first wave of people to be cured of hep C using the latest highly effective, interferon-free medications. Her journey from injection drug user to wellness advocate spans decades, but she believes that it has all been worth it. Go to page 6 to read about the steps she took to start and keep living a healthy life.

Even with all the latest drugs making treatment easier and faster than ever before for most HCV-positive people, some folks living with the virus are still not cured. A small number of them may have gone through the new treatments unsuccessfully, which is increasingly rare but nonetheless possible.

However, more often than not these days the reason many people with hep C have not started treatment is because the new drugs are not yet approved for their genotype. HCV has seven different genotypes, or genetic structures.

Most of the new drugs are approved for genotype 1, which is the most common worldwide and in the United States.

Recently, new drugs were approved for those with genotypes 3 and 4. Go to page 4 to read more about these new drugs. Also, get the latest updates on difficult-to-treat cases, shorter treatment lengths and other hepatitis news.

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 © 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.

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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

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TREATMENT NEWS

Technivie Approved for Genotype 4

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Daklinza Approved for Genotype 3 The U.S. Food and Drug Administration (FDA) has approved the combination of Bristol-Myers Squibb’s (BMS) NS5A inhibitor Daklinza (daclatasvir) with Gilead Sciences’ Sovaldi (sofosbuvir) to treat genotype 3 of hep C. This is the first hep C regimen ever to be specifically approved for this genotype, which makes up an estimated 12 percent of U.S. cases of the virus.

“Daclatasvir is a terrific drug,” says Daniel Fierer, an associate professor of medicine and infectious disease specialist at Mount Sinai Hospital in New York City. “I wish we hadn’t had to have waited over a year and a half beyond the approval of sofosbuvir, but I’m glad we have it in hand now.”

BMS has set the price of Daklinza at $63,000 for the recommended 12-week regimen. So considering Sovaldi’s $84,000 list price, the total treatment cost (before potential discounts to insurers) for the combo will be a staggering $147,000.

The approval is based on a Phase III trial of the two drugs among 152 people with genotype 3. Ninety percent of those new to treatment and 86 percent of those who’d failed a previous attempt were cured. Ninetysix percent of those without cirrhosis beat hep C. The cure rate for study participants with cirrhosis, however, was only 63 percent.

ALL IMAGES: THINKSTOCK

The U.S. Food and Drug Administration (FDA) recently approved AbbVie’s single-tablet combination regimen Technivie (ombitasvir/ paritaprevir/ritonavir) plus ribavirin to treat genotype 4 of hepatitis C virus in those without cirrhosis. This is the first time the FDA has approved an interferon-free treatment for genotype 4.

Technivie effectively comprises one of the two tablets in AbbVie’s Viekira Pak (ombitasvir/ paritaprevir/ritonavir; dasabuvir), which was approved to treat genotype 1 in December 2014.

Perhaps looking to avoid the public relations pinch Gilead Sciences encountered when it priced Sovaldi (sofosbuvir) at $1,000 per pill, or $84,000 for a 12-week treatment, AbbVie has set the price of Technivie at $76,653 for 12 weeks of therapy.

Technivie’s approval was based on a Phase IIb study in which all 91 participants without cirrhosis—49 of whom had and 42 of whom had not been treated before—were cured after 12 weeks of Technivie and ribavirin.

Another 44 treatmentnaive participants took Technivie without ribavirin for 12 weeks; 40 of them (91 percent) were cured.

Excellent Cure Rates Achieved in Difficult-to-Treat Cases Studies of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) and AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ ritonavir; dasabuvir) have boasted excellent cure rates among people with genotype 1 of hep C and cirrhosis.

Researchers examined pooled results of seven Phase II and III trials in which Harvoni was given for 12 or 24 weeks, with or without ribavirin, to people with genotype 1 and cirrhosis.

Cure rates ranged from the low 90 percent range to 100 percent.

An average of 95 percent of those who took just Harvoni for 12 weeks were cured, as were 98 percent of those who took the tablet for twice that long. Those who took Harvoni and ribavirin for a respective 12 and 24 weeks had a 96 percent and 100 percent cure rate. Among study participants who had failed a previous treatment attempt, 90 percent were

cured if they took 12 weeks of just Harvoni, as were 96 percent of those who doubled the treatment time and took ribavirin.

Meanwhile, a Phase IIIb trial tested 12 weeks of Viekira Pak among 60 people who had compensated cirrhosis, the milder stage of the condition, and genotype 1b of hep C. (Genotype 1 has two subtypes, 1a and 1b.) All of them were cured.

“For patients with cirrhosis and none of the complications of cirrhosis like bleeding varices [dilated blood vessels] or fluid in the abdomen, they should be treated as soon as possible with no need to wait for future treatments,” says Andrew Muir, MD, chief of gastroenterology at Duke University.

“The questions remain in the patients with more advanced cirrhosis, and especially for those who are eligible for a liver transplant.”

ALL IMAGES: THINKSTOCK

Injection Drug Use Fuels Outbreaks The Centers for Disease Control and Prevention (CDC) has issued an alert to public health departments and clinicians nationwide to be vigilant for HIV outbreaks similar to one that has struck rural Indiana, while warning of overlapping hep C transmission among injection drug users.

Nationally, acute hep C infections rose 150 percent between 2010 and 2013 as an epidemic of addiction to opioid painkillers has swept the country, which has often led people to inject heroin as a cheaper or more readily available alternative to the prescription drugs. The Indiana outbreak, in which at least 175 residents have been diagnosed with HIV, with 92 percent of them coinfected with hep C, is related to injection of the opiate Opana (oxymorphone).

The CDC estimates that between 2006 and 2012, injection drug use fueled a 3.6-fold rise in the number of new annual hepatitis C cases in four states southeast of Indiana: Kentucky, Tennessee, Virginia and

West Virginia. Just under half of the nearly 1,400 new cases of the disease reported in these Appalachian states during that time were among people age 30 and younger.

“To get out in front of this epidemic, the CDC is looking for ways to rapidly detect transmission of hepatitis C,” says John Ward, MD, director of the agency’s Division of Viral Hepatitis. “Prevention efforts include regular hepatitis C and HIV testing, rapid links to care and treatment for those infected, access to substance abuse treatment, risk reduction counseling, and sterile injection equipment for those who are actively injecting.”

The Race Is On to Shorten Length of Treatment With about half of people with genotype 1 able to take just eight weeks of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir), the race is on to best this treatment length or offer it to more genotypes.

Gilead tested six weeks of a fixed-dose combo pill of Sovaldi (sofosbuvir) and a drug called GS-5816, plus GS-9857 (both the latter agents are experimental) among people with genotype 1 of hep C in a recent small trial.

Among participants treated for the first time, 93 percent of those without cirrhosis and 87 percent of those with cirrhosis were cured. Just 67 percent of those who’d failed a previous cure attempt succeeded with this treatment.

In another small trial of Merck’s combo of grazoprevir/ elbasvir (up for FDA approval as of press time) plus Sovaldi, eight weeks of treatment worked well among people with genotype 1 or 3 who were treated for the first time.

Among people with genotype 1, 94 percent of those with cirrhosis were cured after eight weeks, and 87 percent of those without cirrhosis beat hep C after six weeks.

Eight weeks cured 93 percent of those with genotype 3 without cirrhosis, while 12 weeks cured everyone in this demographic and 91 percent of genotype 3s with cirrhosis.

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FEATURE

Yoga enthusiast Sheila Dewey was cured of hep C in 2014.

JOURNEY TO A

CURE How to get and stay healthy before, during and after treatment

WINNI WINTERMEYER

By Casey Halter

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In October 2014, Sheila Dewey—mother of six, yoga enthusiast and railroad worker from just outside Sacramento, California—was among the first wave of people to be cured of hepatitis C virus (HCV) using the latest highly effective, interferon-free medications.

However, her 18-year journey from diagnosis to treatment was far from easy. Dewey was diagnosed with hep C at age 37 in 1996, at the first comprehensive physical she’d had since becoming an injection drug user (IDU) in her teens.

“I went totally the opposite of what I was taught, and spent a lot of years just beating myself up,” says the preacher’s daughter, who split with her Christian faith during adolescence. She married at 19, had children and developed a drug habit, and as a result was in and out of jail for much of her young adult life.

Despite her past, Dewey left her addiction behind, getting healthy while waiting for HCV treatment. “There is hope,” Dewey laughs. “Make the right choices and get the right people to help you.” Here, she outlines the steps she took to start and keep living a healthy life.

Step 1: Overcome Addiction

Dewey says that her hep C diagnosis was the beginning of her journey to a cure. “I wanted to change. I realized I’ve got one body and I’ve got to start taking care of it,” she recalls.

In that respect, Dewey’s story is not unique. Today, injection drug use is the most common means of HCV transmission in the United States. The U.S. Centers for Disease Control and Prevention estimates that hep C prevalence is approximately 70 to 90 percent among older users like Dewey. The high incidence is largely attributed to needle-sharing during the 1970s and 1980s, before anyone knew the risks of HCV and other blood-borne viruses.

“When I first got diagnosed with hep C, [my doctors] were like, ‘Oh yeah, you’re an addict, most addicts get it,’ and that’s all they told me,” Dewey says. “But I kept seeing so many of my friends pass from overdosing and just bad health in general that I wanted to change.”

So, throughout the late ’90s, Dewey did everything she could to abstain. She attended an outpatient program, reconnected with her faith and started attending peer support programs, eventually launching a Christian 12-step program at her father’s church. Dewey didn’t know that much about hep C at the time, but she believed the first step to building back her health was to kick her drug habit.

That’s the best first move you can make as an IDU with hep C, says Judith Feinberg, MD, associate chair of medicine at the University of Cincinnati, who has devoted much of her career to researching the links between heroin, hep C and HIV/ AIDS. In fact, it’s the No. 1 prerequisite many doctors have for patients to be eligible for HCV treatment.

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“It makes no sense to fix one liver toxin if you’re not going to stop the other toxin,” says Feinberg. It’s an easy link to understand, since the liver’s main job is to filter out all the poisons from the body and the bloodstream.

Even early on, hep C interferes with this toxin-filtering process and is a big risk to the health of HCV-positive IDUs, says Feinberg. In its later stages, the virus can even affect the body’s ability to metabolize drugs, potentially increasing overdose risk and causing liver-destroying chemicals to remain in the bloodstream far longer than in HCV-negative people.

Guidelines from the American Association for the Study of Liver Disease advise doctors not to treat people who have hep C until they kick their injection drug use. The same goes for alcohol abuse.

Experts across the board say that living with hep C is like having simmering coals in your liver, and that drinking alcohol is tantamount to pouring lighter f luid on them. Alcohol causes swelling in the liver and higher hep C viral loads, and it increases the chance of developing cirrhosis (scarring of the liver). It also ups a person’s risk for developing HCV-related liver cancer, transplants and even death.

So Dewey quit drugs and alcohol and set herself on the road to a new life. However, post-addiction, she realized that she needed to make a few more changes.

Step 2: Get Healthy

“I did no cigarettes and no drinking, and I also tried to knock out a lot of the sugars from my diet,” says Dewey. Long gone were her days of cream-and-sugar coffee; “I switched to creamer only,” she says. She did so at the advice of her doctor, a hepatologist referred to her by Dewey’s primary care provider.

What may seem like a trivial dietary cutback is far from it, say liver disease experts. Several studies show that high blood sugar can actually speed the progression to cirrhosis in people living with hep C. At the same time, cirrhosis tends to increase the body’s insulin levels, a fact that’s especially important to people who are also living with diabetes.

As for Dewey’s creamer-only coffee, there are now several studies showing that she was on the right track—drinking coffee, whether decaf or regular, can actually have a protective effect on the liver.

Dewey also swears by her cucumber-ginger shakes and has switched to a diet full of fruits and vegetables. She also tries to avoid fatty, high-calorie meals and processed foods as much as possible.

However, aside from eating well, doctors say there isn’t

much you can do in the way of quick medical fixes to avoid hep C progression.

“Milk thistle, licorice, multivitamins—I don’t think these things work. This kind of ‘voodoo medicine’ is not good for the liver,” warns Feinberg, when asked about alternative therapies or diets to consider while waiting for hep C treatment.

Milk thistle, the most popular herbal remedy for hep C, is often thought to reduce liver inflammation and possibly have an antiviral effect. However, a 2008 study conducted by the European Association for the Study of Liver Disease found no direct improvements in people who took it.

As for licorice root, a 2002 study found that compounds within the plant could help prevent liver cancer from developing in chronic hep C patients. However, the herb was only effective when taken intravenously, not in supplement form— and it also caused high blood pressure, which increases liver disease risk.

Regarding multivitamins, doctors like Feinberg generally advise against them. In particular, HCV-positive people are advised to avoid iron supplements, since iron can speed up liver scarring. However, doctors do recommend low-iron children’s vitamins for those who are truly adamant about mineral deficiencies.

After switching up what she regularly ate, Dewey had one more not-so-secret trick up her sleeve: “I work out a lot,” she says. Studies show that people who are of a healthy weight have far slower liver disease progression than those who aren’t, proving Dewey once again put herself on the right track.

Dewey had been a cross-country runner in high school, so she already knew the drive and determination it takes to get in shape. She started working out four times a week (“body pumps and a cardio core,” Dewey says) through a gym membership paid for by her job. She also takes Bikram yoga classes, sweating out vinyasas and power flows in 105-degree heat three times a week.

“I see a lot of people my age saying, ‘My back! My legs!’ So I try to keep it moving,” Dewey says. She’s also motivated by the fact that she’s required to lift 75-pound packages on a regular basis at her job as a supply clerk at the Union Pacific Railroad in Elk Grove, California.

Despite getting healthy, Dewey still had concerns. “If you have hepatitis C, it puts you more at risk of getting liver cancer, so I didn’t want to keep waiting,” she says.

more, since she had been taking such good care of her health, Dewey didn’t have a lot of the liver damage that often results from the virus, or any of the comorbidities like heart disease or obesity that can make HCV worsen faster.

“I don’t have high blood pressure, I don’t have diabetes, so I felt blessed,” she recalls. “Because I was living a healthier life, I could wait for better medication.”

“Dewey’s story is not rare,” Feinberg says. “A lot of people who got hep C didn’t go on treatment [right away]. Interferon didn’t work that well and was very toxic. Plus, for the last five years or so, people have known that better things were coming.”

In fact, by the time the 2000s hit, Dewey’s doctors started telling her about HCV drugs that were in the pipeline. These new cures were expected to be much more successful and have far fewer side effects than previous interferon-based cures. So Dewey, with the help of her medical team, kept waiting.

Starting in 2013, those treatments finally made their way through approval by the U.S Food and Drug Administration.

The first was Gilead Sciences’ Sovaldi (sofosbuvir), an all-oral cure. By early 2014, folks like Dewey were finally getting cured, at rates upward of 90 percent and with few side effects.

Because she had never been treated before, had been living with hep C for such a long time and was in good health otherwise, Dewey’s doctors got her in a clinical trial to access one of these breakthrough new treatments.

In July 2014, Dewey started an experimental drug regimen through Merck, called MK-5172/MK-8742.

Throughout treatment, Dewey kept going to work every day, continued her weekly workouts and kept up with the busy lives of all her kids and grandkids.

“I didn’t stop anything,” she says. Plus, she got paid for the trial.

Finally, after 12 weeks of treatment, in October 2014, Dewey’s doctors and research team told her she was cured. She underwent eight weeks of post-trial follow-up.

Today, she is living a life free of both addiction and HCV.

“There is hope.

Make the right choices and get the right people to help you.”

Step 3: Find Treatment

Since being diagnosed with hep C nearly two decades ago, Dewey made sure she kept up on annual appointments with her hepatologist, getting tested every year for liver function numbers and viral load counts to make sure she was not in danger of a major health crisis.

Luckily for Dewey, hepatic inflammation generally doesn’t start until 10 to 20 years after an initial hep C infection. What’s

Step 4: Live Life

Thanks to HCV treatment, Dewey has lowered her risk for liver cancer by up to 70 percent and the risk of liver-related death or a transplant by 90 percent. Now, she’s all about helping injection drug users through their own journeys to health and a hep C cure.

“I really believe in reaching back and giving others hope,” says Dewey. “So many people think, ‘How can I ever stop using?’ and I say, ‘If I can stop, anyone can stop.’”

Dewey is still running her Christian 12-step program, reaching out about hep C to her church community and volunteering at a group home in her spare time. She also regularly talks with her friends who are still struggling with addiction.

Next up for Dewey on her hep C treatment advocacy journey is a deeply personal step—her husband of 34 years is going to start HCV treatment soon. ■

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