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Going Global Fighting for people with liver disease
Donna Cryer
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FROM THE EDITOR
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CONTENTS 3 FROM THE EDITOR Advocating for people with liver disease
onna Cryer is the founder and CEO of the Global Liver Institute (GLI). The nonprofit organization seeks to improve the lives of people with liver disease, which affects up to 30 million Americans. GLI advocates for many liver-related conditions, including viral hepatitis and fatty liver disease. In particular, GLI leads International NASH Day. Held each year on June 12, it educates the public about non-alcoholic steatohepatitis, an advanced form of fatty liver disease. Five years ago, Cryer saw a need to create GLI in response to a lack of prioritization of liver disease in general, compared with other conditions. To that end, GLI is working with other groups to pass the LIVER Act in Congress. If enacted, the law would elevate the status of liver disease and substantially increase funding. “We’re not even in the room right now,” she says of liver health advocates in Washington, DC, “so this would get all liver organizations more respect.” As a Harvard graduate and a lawyer, Cryer definitely has the background to be a successful advocate. In addition to these skills, she personally struggles with liver disease. The combination has certainly earned her respect as a leader in the health care arena. She has fought a lifelong and ongoing battle with inflammatory bowel disease (IBD), which can also affect the liver. It got so bad that she needed a liver transplant. She received a new liver in 1994. Go to page 8 to read more about her journey. As GLI has recognized, the urgency of fatty liver disease is only increasing. In North America, about one in four
people have non-alcoholic fatty liver disease (NAFLD). Approximately 5 million Americans have NASH, a more severe form of NAFLD. Both conditions often occur with fibrosis, which is scarring of the liver. No medications have yet been approved to treat such related liver damage. However, a recent study assessed the pipeline for such therapies. Go to page 6 for more. At one point while Cryer was on a liver transplant list, she was told that she had seven days left to live. In the United States, nearly 113,000 people are on organ transplant waiting lists. Hundreds die every year while waiting for an organ. In an effort to mitigate the shortage, doctors are increasingly turning to organs from donors who were living with hepatitis C virus (HCV). Now that HCV is highly curable, with more than a 90% success rate, many people are willing to receive such organs. Go to page 4 for more.
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4 NEWS Transplanting organs with hep C • ruling favors safe injection sites • inmates sue for hep C treatment • $3M to study CBD for pain relief
6 CARE & TREATMENT All adults should be screened for hep C • where are the NASH fibrosis treatments? • treat opioid addiction, prevent hep C reinfection • benefits of hep C cure after liver cancer
8 PROFILE Personal struggles with liver disease led Donna Cryer to advocacy.
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NEWS
Transplanting Organs With Hep C In the United States, nearly 113,000 people are on organ transplant waiting lists. Hundreds die every year while waiting for an organ. In an effort to mitigate the shortage, doctors are increasingly turning to organs from donors who were living with hepatitis C virus (HCV). A recent report from Reuters overviews the latest research on transplantation of HCV-positive organs. Until recently, hospitals and transplant centers have typically discarded organs from donors with hep C because of the transmission risk. However, now that HCV is highly curable (with more than a 90% success rate), many doctors—and patients—are willing to receive a transplant that could result in an infection. Doing so can help significantly reduce the amount of time people spend on organ waiting lists, allowing them to get well faster and potentially saving thousands of lives. Currently, in the case of most HCV-positive transplants, patients receive an infected organ and are treated to cure their hep C later, once their bodies have recovered. However, new research hopes to streamline the process and reduce the amount of time people have to live with the infection—or, better yet, develop methods that can prevent an infection altogether.
For example, a recent study showed that treating people for hep C with direct-acting antiviral therapy just hours after transplant surgery could successfully ward off an infection. Other researchers are testing whether ultraviolet light can deactivate HCV in organs before they’re transplanted. Advances could one day allow doctors to evaluate and rehabilitate organs affected by a variety of illnesses— from hep C to fatty liver disease. —Casey Halter
A federal judge has struck down the government’s latest attempt to block the opening of what could become the first supervised injection site in the United States. On October 2, U.S. District Judge Gerald McHugh ruled that Philadelphia’s proposed Safehouse facility does not violate the so-called crack house provision of the federal Controlled Substances Act, which makes it a crime to operate a site where illegal drugs are produced, distributed or consumed. “We have maintained that the federal laws couldn’t possibly be interpreted to stop people from saving other people’s lives,” Ronda Goldfein, Safehouse vice president and director of the AIDS Law Project of Pennsylvania, told the Philadelphia Inquirer. Indeed, Judge McHugh concluded in his ruling that there was no credible argument that Congress was considering safe injection sites when it adopted the crack house rule in 1986, as “their use as a possible harm
reduction strategy among opioid users had not yet entered public discourse.” The Department of Justice indicated that it would appeal the decision. Safe injection facilities—also known as supervised consumption or overdose prevention sites—allow people to bring drugs they obtain elsewhere to use under the watch of trained staff, reducing the risk of overdose death. Staff provide sterile needles, which prevents transmission of HIV and hepatitis B and C. Indoor sites also reduce street-based drug use and improper syringe disposal. Finally, they offer an entry point for medical care, hep C treatment, addiction treatment and an array of other services for people who use drugs. There are more than 120 safe injection sites in at least 10 countries, but there are currently no authorized facilities in the United States. —Liz Highleyman
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Ruling Favors Safe Injection Site
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Inmates Sue for Hep C Treatment A federal lawsuit filed in Texas alleges that the state’s prison system is “callously” denying thousands of inmates access to hepatitis C virus (HCV) treatment, the Houston Chronicle reports. Similar lawsuits have been filed in at least a dozen states over the past few years. As with other prison HCV cases, the lawsuit claims Texas’s failure to provide next-generation treatment to its inmates constitutes “cruel and unusual punishment” at the hands of state prison officials and violates both the Eighth Amendment and the Americans with Disabilities Act. The lawsuit also argues that the state has a duty to provide access to adequate medical care to all prisoners regardless of cost. It is estimated that at least 18,000 inmates in Texas’s 104 jails and prisons have been diagnosed with hep C—accounting for up to 30% of the state’s entire prison population. Meanwhile, Texas prison officials say the cost of providing treatment for the virus would be $63,000 per patient. The class action lawsuit was filed on behalf of Matthew Roppolo, a 53-year-old Houston man incarcerated at the McConnell Unit who said he is aware of at least one instance years ago in which a fellow prisoner’s request for HCV treatment was denied. Weeks after his release, the suit claims, that man died of liver cancer. Inmates who don’t receive treatment could be asymptomatic for decades. But studies on liver disease progression suggest that 25% to 40% will go on to develop cirrhosis, or liver scarring, which significantly increases the risk for liver cancer. People with untreated HCV are also at an increased risk for diabetes, leukemia, lymphoma, skin conditions and kidney disease. Curing HCV significantly mitigates those risks. —CH
$3M to Study CBD for Pain Relief The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, has announced that it will grant nine new research awards, totaling approximately $3 million, to study the potential pain-relieving properties of cannabidiol (CBD) and other nonpsychoactive components of cannabis. “The treatment of chronic pain has relied heavily on opioids, despite their potential for addiction and overdose and the fact that they often don’t work well when used on a long-term basis,” NCCIH director Helene Langevin, MD,
said in a statement. “There’s an urgent need for more effective and safer options.” Cannabis contains multiple compounds known as phytochemicals, including more than 110 cannabinoids and 120 terpenes, according to the NCCIH. The most familiar of these—and the only one that has been studied extensively to date—is tetrahydrocannabinol (THC), which is chiefly responsible for marijuana’s psychoactive, or high-inducing, effects. CBD, a nonpsychoactive component, is widely used for a variety of conditions, including relief of pain, anxiety, depression, insomnia and nausea. Although 11 states and Washington, DC, currently allow recreational use of cannabis and many more have authorized medical marijuana, CBD is legally available throughout the United States. The new awards support research on a broad range of marijuana cannabinoids and terpenes as well as terpenes from hops, a plant related to cannabis that’s best known as an ingredient in beer. Together, these studies should shed more light on the potential benefits and possible risks of CBD and other marijuana compounds, which are increasingly used despite the current lack of evidence. “The science is lagging behind the public use and interest,” said NCCIH deputy director David Shurtleff, PhD. “We’re doing our best to catch up here.” —LH
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CARE & TREATMENT BY BENJAMIN RYAN
All Adults Should B Screened for Hep C The U.S. Preventive Services Task Force has issued a new recommendation that all adults ages 18 to 79 should be screened for hepatitis C virus (HCV) at least once, regardless of whether they have risk factors for the virus. Those under 18 or over 79 should also be screened if they do have such risk factors, which include having ever shared syringes or other equipment for drug injection. Individuals at ongoing risk should be tested periodically. The task force previously recommended one-time universal HCV screening only for baby boomers—those born between 1945 and 1965—given the fact that this birth cohort has long accounted for the bulk of U.S. infections. But as the opioid epidemic has expanded in recent years, hep C rates have risen among younger individuals. Thanks to evidence indicating that the benefits of screening and follow-up care outweigh any harms, the task force gave the new recommendation what’s known as a B grade, which requires that insurers cover the tests. The screening recommendation, the task force stresses, includes pregnant women. HCV can be transmitted from mother to child during pregnancy or delivery. Douglas K. Owens, MD, the chair of the task force and an investigator at the Center for Innovation to Implementation at the Veterans Affairs Palo Alto Health Care System, says he hopes the broadened testing recommendation “will help ensure more Americans with hepatitis C detect the disease early and get the treatment they need to stay healthy.”
About one in four people in North America have non-alcoholic fatty liver disease (NAFLD), in which excess fat accumulates in the liver of an individual who drinks little or no alcohol. NAFLD and its more severe form, nonalcoholic steatohepatitis (NASH), is a top driver of liver disease, including cirrhosis and liver cancer. NAFLD and NASH often occur with fibrosis, or scarring, of the liver, and yet no medications have been approved to treat such liver damage in this context. In a recent review paper, Joseph J. Alukal, MD, of Mercy Medical Center in Baltimore, and Paul J. Thuluvath, MD, of the University of Maryland School of Medicine, assessed the pipeline for such therapies. “Early results from some Phase II and Phase III trials are encouraging,” they wrote, “and we believe that therapeutic agents which can halt or improve fibrosis may be available in the near future.” Indeed, four notable medications that target at least one of the pathways that drive NASH and fibrosis are currently in Phase III trials. The drugs need to achieve the key benchmark of improving fibrosis by one stage without any worsening of NASH. One such drug, called Ocaliva (obeticholic acid, or OCA), satisfied those key criteria. Another, selonsertib, has yielded disappointing results, while a third, elafibranor, did not meet the criteria but did show promising results among those with more severe cases of NASH. Lastly, the drug cenicriviroc reduced fibrosis among people with NASH and mild to severe fibrosis, with better results among those with worse liver disease at the study’s outset.
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Where Are the NASH Fibrosis Treatments?
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Treat Opioid Addiction, Prevent Hep C Reinfection People with a history of injection drug use who receive medicationassisted treatment (MAT)—such as methadone, buprenorphine or naltrexone—for opioid use disorder have a low hepatitis C virus (HCV) reinfection rate after they are cured of the virus, a new study shows. Researchers recruited 141 participants from a randomized controlled study that assessed various means of providing care to people with a history of injection drug use who were receiving MAT in the Bronx in New York City. A total of 114 of the participants, all of whom were cured of HCV, made at least one of the study follow-up visits, which were scheduled every six months for up to two years. Following the 24-week mark after they completed their hep C treatment, 19% of these individuals reported ongoing injection drug use. Three people, all of whom reported injecting drugs during the
follow-up period, were reinfected with HCV during a cumulative 246 years of follow-up, yielding a reinfection rate of 1.2 cases per 100 cumulative years of follow-up for the entire group, which is considered a low rate. However, among those who reported ongoing injection drug use, the reinfection rate was much higher, at 7.4 cases per 100 cumulative years of follow-up. The study authors found that reinfection was associated with reported ongoing injection drug use, a lack of confidence in the ability to avoid contracting hep C, homelessness and living with a person who injects drugs. According to the study’s lead author, Matthew J. Akiyama, MD, MSc, an assistant professor of medicine at Albert Einstein College of Medicine in New York City, the low overall reinfection rate among the participants suggests that “concerns about reinfection should
not limit HCV treatment” for people who inject drugs, especially if they are receiving MAT. “Treatment as a form of prevention may be even more important among those who continue to inject drugs while on [MAT] to reduce HCV transmission,” he says.
Benefits of Hep C Cure After Liver Cancer Treating and curing hepatitis C virus (HCV) with direct-acting antiviral (DAA) drugs is associated with a much lower risk of death among those with a history of successfully treated hepatocellular carcinoma (HCC), the most common form of liver cancer. Previous studies indicated that DAA treatment was not associated with a higher risk of liver cancer recurrence, and the new study appears to confirm that DAAs decrease health risks for people with HCV and a history of liver cancer. The authors of the new study analyzed data on 797 people with HCV-related liver cancer in the United States and Canada who received
successful treatment for the malignancy between 2013 and 2017. A total of 383 (48%) of the study members received DAA treatment, 43 (11%) of whom died during 941 cumulative years of follow-up. Of the 414 people who were not treated with DAAs, 103 (25%) died during 527 cumulative years of follow-up. After adjusting the data to account for various factors, the authors of the study found that DAA treatment was associated with a 46% reduced risk of death during follow-up. Individuals who were cured with DAA therapy had an even greater 71% reduction in mortality, though those who were not cured did not see a significant benefit. “Our study demonstrated that hepatitis C therapy is safe and improves survival in this growing group of patients [about whom] there was uncertainty about best practices,” says study leader Amit Singal, MD, the medical director of the University of Texas Southwestern Liver Tumor Program in Dallas. “These results change the paradigm from you could treat a patient’s hepatitis C in these patients to you should treat it.”
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PROFILE
Donna Cryer stands up for people with liver disease at the Washington, DC, headquarters of the Global Liver Institute.
Going Global Personal struggles with liver disease led Donna Cryer to advocacy. By Tim Murphy Photography by Jonathan Timmes
D
onna Cryer is a liver policy wonk par excellence.
She’s not only a Harvard graduate and lawyer but also the founder and CEO of the five-year-old Global Liver Institute (GLI), whose aim is to improve the lives of people living with liver disease, which affects up to 30 million Americans. But Cryer, who lives and works in the Washington, DC, area, came to her work the personal way: via a lifelong, ongoing struggle with inflammatory bowel disease (IBD), an
umbrella term for conditions caused by chronic inflammation of the gastrointestinal tract. IBD can also affect the liver. It got so bad that she needed a liver transplant, which plunged her into patient advocacy. “I don’t look back wishing that things were different,” says Cryer. “I just see that I was able to use what I’ve gone through to develop and grow as both a person and a leader. It has given me a certain resiliency that hopefully pervades everything I do.”
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That journey started in Connecticut, where Cryer was one of a few students of color at elite private schools and where she struggled from an early age with the stomach pain and diarrhea of IBD. “It was so embarrassing and horrible, having to make bathroom stops on bus trips, going to the nurse all the time,” she says. Thankfully, her mother was nurturing, and her father was tough, telling her never to give up the fight—a message that propelled her to Harvard in the late 1980s. There, her IBD caused increasingly bad liver disease, which causes jaundice (yellowing) in the eyes. “One Halloween, I went as a tiger,” she recalls, “and everyone was like, ‘How did you get your eyes so yellow?’ and I’d say, ‘It’s a secret.’” Eventually, she was put on a liver transplant list and at one point was told that she had seven days left to live if she did not get the transplant. Thankfully, in 1994, she did—at the Johns Hopkins medical center, with friends from both Harvard and Georgetown—where she was by then enrolled in law school—by her side. “I saw them at a reunion recently,” she says, “and they confided, ‘We were so scared you were going to die!’” Although she had to miss her first semester of law school because of the transplant, the surgery was a success. Post-procedure, she considered going into child welfare law, but her doctors, impressed by her burning curiosity about her condition and level of care, urged her to get a job with the United Network for Organ Sharing (UNOS), the nonprofit that manages the U.S. transplant system, including its all-important waiting lists. After that, she worked for a clinical
she says, “and asked her to partner with me and talk to other people being cured of HCV.” A dedicated website, YouTube channel and shareable infographics for social media were all part of the push to get the word out. Other accomplishments include working with hepatitis advocates to craft the LIVER Act and champion it in Congress. If passed, the law would take bold steps to prioritize liver disease, including authorizing an additional $45 million a year for five years for liver cancer and hepatitis B virus research at the National Institutes of Health (NIH), raising the profile of liver disease at the NIH by adding “Liver” to the name of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and elevating the Liver Disease Research Branch at NIDDK to its own division, which would report directly to the NIH director. “We’re not even in the room right now,” she says of liver health advocates in DC, “so this would get all liver organizations more respect.” GLI also leads International NASH Day, held annually on
June 12, which educates the public about and advocates for the roughly 5 million Americans living with non-alcoholic steatohepatitis, an advanced form of obesity-linked fatty liver disease. GLI oversees related events in 22 countries with 65 partner organizations. NASH is expected to affect 28% of the world by 2030. Other priorities include getting organ procurement organizations to be more transparent about where donated organs go; raising the amount of money that people can be reimbursed by insurers for donating their own organs, which requires taking time off from work; and growing GLI’s advocacy academy for patients and caregivers who want to become liver policy advocates. (Start the journey yourself by signing up at globalliver.org/ liver-health-policy-updates.) Cryer’s biggest challenge? “Low levels of awareness about liver health overall,” she says. “We walk into congressional offices and have to educate [lawmakers] about how many people in a district this could impact.” Despite all the advocacy work, Cryer says she finds time for fun stuff like SoulCycle, yoga and weight lifting. “They help with the pressures and responsibilities of work as well as with my IBD,” which she still battles. “It doesn’t help anybody if I get sick, so I consider this giving my own wellness the recognition I deserve.” And she admits that she may have the Hallmark Channel playing in the background to soothe her nerves—“something really vanilla,” she says— and that she’s a Marvel Comics fangirl. But despite the burdens she carries, she doesn’t regret that her personal health challenges have determined her career. “It’s a blessing to have found such a clear purpose,” she says, “and know I’m able to have a meaningful impact on so many people’s lives.” Q
“It’s a blessing to have found such a clear purpose.”
trials consulting group, reaching out to Black sororities and fraternities to help recruit more people of color to participate in studies. Then it was on to the public relations firm Hill+Knowlton, where, Cryer says, her intimate knowledge of the patient world allowed her to think innovatively for clients and she often collaborated with grassroots community groups. But on the 20th anniversary of her transplant, she says, “I sat and thought deeply. Was I confident that other [liver] patients would have the same access to innovations in medicine, surgery and care delivery that saved my life? The answer was no because in general there are low levels of awareness about liver health. And there didn’t seem to be a place that represented the large number of liver patients around the world.” So she took a page from the late literary legend Toni Morrison. “She wrote that if you can’t find the book you want to read, you were meant to write it,” says Cryer. “So that’s what GLI is to me, writing the story that I was looking to read.” She launched the organization in 2014, right around the time the new drugs for hepatitis C virus (HCV) were coming out. “I put together a campaign where I sought out a woman who had finally been cured from hep C with the new meds,”
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