A SMART+STRONG PUBLICATION FALL 2018 HEPMAG.COM
Hannibal Returns A pro wrestler cured of hepatitis C gets back in the ring
Beat Hep C, Live Longer? Direct-acting antivirals improve overall survival
Expanding Treatment Access Pricing strategy could lower drug prices
Advancing Precision Medicine A new initiative to accelerate research
Devon Nicholson
Got Ink? An estimated 3–5 million Americans are living with hepatitis C. Most don’t know it. Get tested today.
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FROM THE EDITOR
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CONTENTS 3 FROM THE EDITOR The importance of getting treatment for hepatitis C
evon Nicholson learned he was living with hepatitis C virus (HCV) in 2009. He got the diagnosis as part of a routine physical screening by World Wrestling Entertainment (WWE). Nicholson received his HCV-positive test result just when he hoped his pro wrestling career would finally reach the next level. Instead, the WWE contract was rescinded. All those years of hard work, including amateur wrestling in high school and professional wrestling, seemed to have been for nothing. It was during those years that he earned the nickname “Hannibal,” after Dr. Hannibal Lecter from The Silence of the Lambs. It was also during those years that he believes he contracted HCV from another wrestler while in the ring. Consequently, he took that wrestler to court and won his case against him in 2014. Before winning in court, Nicholson won his fight against hep C—he was cured in 2012—but going through treatment wasn’t easy. At first, he used an older regimen, which had horrible side effects and didn’t work. Then he went on newer treatment but still had to deal with bad side effects. The latest treatments have virtually no side effects. Now that those battles have been won, Nicholson has started a new chapter in his life. He has a production company that stages pro wrestling events in and around Canada and has revived his Hannibal character to compete in them. He has a successful YouTube channel and has embarked on an acting career. He is even competing in mixed martial
D
JENNIFER MORTON
arts. Go to page 8 to read more. As Nicholson’s HCV journey demonstrates, getting cured of the virus isn’t about being healthier for its own sake, it’s about living longer to be able to achieve your goals. Luckily, it turns out that beating hep C using direct-acting antivirals can improve overall survival. People who get cured of HCV likely even improve their outcomes when it comes to numerous non-liver-related health conditions. Go to page 6 to learn more. Being motivated to get hep C treatment is important, but often it’s not enough. Expanding access to treatment remains a challenge. Although the latest cures have been available for nearly five years, many private insurers still aren’t paying for treatment. As a result, policy experts have devised a pricing strategy that could help states treat more hep C. Go to page 4 for more information. To learn how to help advance precision medicine, for which treatment is customized for individuals, go to page 5.
ORIOL R. GUTIERREZ JR. EDITOR-IN-CHIEF
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4 NEWS Private insurers still not paying for hep C treatment • Pricing strategy could help states treat more hep C • “All of Us” to advance precision medicine • Doctors transplant lungs from donors with hep C
6 TREATMENT NEWS Beat hep C, live longer? • Hep C cure tied to non-liver benefits • The ABCs of the hep A vax • Liver symptoms still a risk post–hep C cure
8 PROFILE Hepatitis C threw pro wrestler Devon “Hannibal” Nicholson out of the ring, but a cure put him back in the fight.
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NEWS
Private Insurers Still Not Paying for Hep C Treatment Cures for hepatitis C virus (HCV) have been available for nearly five years, but many private insurers still aren’t paying for the treatment, according to a new study published in Open Forum Infectious Diseases. The fight for access to HCV treatment began in 2011, when the Food and Drug Administration approved its first direct-acting antiviral therapy. In 2014, nextgeneration treatments reached cure rates of 90 percent or more, offering hope to the millions of Americans living with the virus. However, the cures have not come cheap. Pharmaceutical companies charge up to $100,000 per patient for a full course of treatment, and insurers have been reluctant to offer the drugs to all but the sickest patients. Researchers at the University of Pennsylvania in Philadelphia
recently set out to determine whether treatment rates have improved over the years since the cures first became available. For the study, researchers examined the hep C treatment prescriptions of more than 9,000 patients submitted between January 2016 and April 2017 to a specialty pharmacy that services 45 states. Overall, 35 percent of those prescriptions were flat-out denied. Patients on private insurance had a 52.4 percent denial rate, compared with 34.5 percent for
Medicaid patients and 14.7 percent for those on Medicare. Nevertheless, there is hope for eliminating the virus across the country if treatment rates pick up. A 2016 report from the National Academies of Sciences estimated that hep C could be eliminated nationwide by 2030 as long as at least 260,000 people receive treatment every year. However, current estimates report that less than 10 percent of the 3.5 million Americans living with HCV have received treatment so far.
Leading experts in hepatitis C virus (HCV) care and policy are recommending a new pricing strategy that could help states ramp up their treatment efforts. The proposed solution, published in the Annals of Internal Medicine, aims to help state lawmakers leverage competition among drug manufacturers and ultimately lower prices for the medications. The state-level recommendations were included in an extended USCBrookings Schaeffer Initiative for Health Policy report at the University of Southern California. It aims to address the fact that most insurers, state Medicaid programs and state prison systems currently cannot afford to treat all the estimated 3.5 million Americans who have hep C. Meanwhile, drug manufacturers argue
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that in order to continue to innovate they must maintain high prices for hep C treatment—a push-and-pull that leaves many sick people unable to access lifesaving cures. Under the proposed model, states would leverage their resources with a particular pharmaceutical company, offering a lump sum payment over a period of time that would generate more revenue than they would ordinarily expect in that time period but less than Medicaid would pay to all the companies producing the treatment. In exchange, the company would agree to provide a 100 percent rebate on drug purchases for a population chosen to receive the cure, such as prisoners. This deal would allow states to expand treatment access while remaining within their budgets.
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Pricing Strategy Could Help States Treat More Hep C
“All of Us� to Advance Precision Medicine
Enrollment has opened for the All of Us Research Program to gather health information via surveys and health records from a diverse group of Americans to accelerate research. The National Institutes of Health (NIH) aims to advance precision medicine, for which treatment is customized for individuals based on patterns uncovered by massive data. The NIH plans to provide data from the program to qualified researchers. Participants will be able to access their own information, summary data about all participants and the study findings. All of Us aims to enroll at least 1 million people, starting with adults (children are to be added in 2019). More than 25,000 participants have already joined as part of a yearlong pilot test. The program encourages the participation of people of every race, ethnicity, sex, gender and sexual orientation and intends to include people previously underrepresented in medical research, especially people of color. Healthy people and those with long-term health issues are welcome. Participants will remain anonymous. Identifying information will be removed from health records and samples will be stored without names in a biobank. The NIH said it would prohibit disclosure of the data to law enforcement. Spanish-speaking advisers are available, and more languages will be added. No health insurance is required, and data collection appointments are free, though the program does not provide medical care.
Doctors Transplant Lungs From Donors With Hep C Doctors in Toronto have successfully transplanted lungs from donors with hepatitis C virus (HCV), giving sick patients a second chance at life and then curing them of the virus. Since 2017, surgeons at Toronto General Hospital have performed HCV-positive transplants in 11 patients as part of a pilot project designed to study the safety of using lungs from donors living with the virus. Current protocol in North America prohibits the use of these organs, but, based on the efficacy of next-generation treatments, doctors have begun questioning this policy. These transplants are possible because of a dome-like device known as the ex-vivo lung perfusion, which was developed in 2008. The device bathes donor lungs in a special solution that can remove up to 85 percent of the residual blood in the lungs that carries hep C.
Post-surgery, recipients were tested for HCV and started on a 12-week course of prophylactic treatment to prevent an infection. At press time, eight transplant patients had finished their therapies; two were still undergoing treatment, and one had yet to receive medication. A new policy permitting the use of HCV-positive organs could provide a huge boost in organ donation, adding roughly 1,000 more lung donors per year in North America. What’s more, as the opioid crisis continues to claim lives, the number of donors with hep C is likely to rise. The study results were presented at the 2018 Global Hepatitis Summit, which took place in Toronto. Going forward, researchers say the procedure could likely expand to include lung, kidney and hear t transplants as well as transplants of the pancreas and small bowel.
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TREATMENT NEWS BY BENJAMIN RYAN
Beat Hep C, Live Longer? Treating and curing hepatitis C virus (HCV) with direct-acting antivirals (DAAs) is associated with a lower risk of death—not just from liverrelated causes but non-liver-related causes as well. That’s according to Italian researchers who examined data on nearly 5,000 people who were recently treated for HCV with DAAs and were followed for a median of 65 weeks afterward. Twenty-four percent of the cohort did not have cirrhosis, 67 percent had compensated cirrhosis (the less severe form of the advanced liver disease) and 9 percent had decompensated cirrhosis (the more severe form of the advanced liver disease). More than 90 percent of the cohort members were cured of hep C. After receiving DAA treatment, 53 participants, or about 1 percent of the cohort, died—23 of them from liver-related causes and 30 of them from other causes, including cardiovascular disease and sepsis. Compared with those who were cured of hep C, those who were not cured were nearly 30 times more likely to die of any cause, including 15 times more likely to die of liver-related causes and 42 times more likely to die of other causes. Compared with those without the liver condition, those with decompensated cirrhosis were 30 times more likely to die of liver-related causes and three times more likely to die of non-liver-related causes. “It is now clear to all physicians involved in HCV treatment that patients who have lived with this disease for years and who finally get [cured] will have a marked improvement in overall survival,” says the study’s lead author, Vincenza Calvaruso, MD, PhD, a lecturer of gastroenterology at the University of Palermo in Italy.
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People who get their hepatitis C virus (HCV) cured likely improve their outcomes when it comes to numerous non-liver-related health conditions. Researchers reached this conclusion after conducting a review and meta-analysis of nearly 50 hep C studies. They compared the development of certain health conditions between those who were and were not cured of the virus. “Some of these conditions are relatively rare but devastating, such as vasculitis,” says Daniel Fierer, MD, an infectious disease specialist at Mount Sinai Hospital in New York City, who was not involved with the study, “but some are quite common, such as insulin resistance.” The study authors found that curing hep C was associated with a 56 percent lower likelihood of dying of non-liver-related causes; a 20-fold increased likelihood of experiencing complete remission of cryoglobulinemia vasculitis (inflammation of small blood vessels caused by clumps of antibodies) among those with the condition; a 58 percent reduced chance among those without diabetes of developing insulin resistance and a 66 percent lower likelihood of being diagnosed with diabetes; a 63 percent lower risk of major adverse health events related to cardiovascular disease and a 30 percent reduced risk of ischemic heart health events (restriction of blood supply to tissues); and an 85 percent lower risk of kidney-related health problems.
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Hep C Cure Tied to Non-Liver Benefits
The ABCs of the Hep A Vax In response to recent outbreaks of hepatitis A virus (HAV), health experts are urging people with hepatitis B and C viruses (HBV, HCV) to get vaccinated against hep A. “Hepatitis A is a highly contagious liver infection,” says Noele Nelson, MD, PhD, MPH, a medical officer in the Division of Viral Hepatitis at the Centers for Disease Control and Prevention. “It can range from a mild illness lasting a few weeks to a severe illness lasting several months. When this disease affects populations with already poor health, such as those with hepatitis B and C infections and chronic liver disease, infection can lead to serious outcomes, including death. Vaccination is the most important tool we have to prevent
hepatitis A and stop outbreaks.” Nelson and her colleagues reviewed data from a large cohort study of people with hep B or C. Of the individuals included in this data set, 33 percent of those with HBV and 34 percent of those with HCV had never been tested for HAV. As for those who had been
tested for hep A, a respective 59 percent and 39 percent of those with hep B and C had hep A antibodies. Of those who tested negative for hep A antibodies, a respective 60 percent and 62 percent of those with hep B and C never got a follow-up hep A vaccination.
Liver Symptoms Still a Risk Post–Hep C Cure Curing hepatitis C virus (HCV) may not eliminate the risk of liver-related symptoms for those who start treatment with what is known as cryoglobulins. These
are clumps of antibodies that can give rise to inflammation and block blood vessels. Researchers conducted a study of 88 people with HCV who had evidence of cryoglobulins circulating in their bodies, including 46 individuals who had symptoms of HCV-driven cryoglobulinemic vasculitis (inflammation of the blood vessels), or CV, and 42 who did not. The study members, who had an average age of 63 years, were followed for a median of two years after being treated for hep C. All of the study members were cured of hep C. At their last follow-up visit, 66 percent of those with such vasculitis symptoms and 70 percent of those without such symptoms saw their cryoglobulins clear up.
Out of the group with CV symptoms, five individuals (11 percent) experienced relapses of these symptoms during the study’s follow-up period; health outcomes among them included severe organ damage and death. “Most clinical manifestations of [hep C] improve over time after viral eradication with direct-acting antivirals,” says the study’s lead author, Martin Bonacci, MD, a hepatologist at the Liver and Digestive Diseases Networking Biomedical Research Centre in Barcelona. “However, in patients with HCV-associated cryoglobulinemic vasculitis, we believe that our data support longer follow-up to make sure recurrence does not occur over time.”
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PROFILE
Devon Nicholson stays fit after hep C.
Hannibal Returns Hepatitis C knocked pro wrestler Devon “Hannibal” Nicholson out of the ring, but a cure landed him back in the fight. By Tim Murphy Photography by Luther Caverly
“I
was in disbelief.”
That’s how 35-year-old pro wrestler Devon Nicholson remembers learning in 2009 that he was living with hepatitis C virus (HCV). “I’d been vaccinated for hepatitis A and B and figured that I was for C as well. I was so upset because I’d worked my whole life toward this contract,” says Nicholson. Unfortunately, there is no hep C vaccine. The contract in question was with World Wrestling Entertainment (WWE), the highest echelon of pro wrestling, the kind of “show” wrestling associated with colorful characters like Hulk Hogan and their ringside antics. “Amateur” wrestling, ironically, is the classical mat sport pioneered in ancient Greece and practiced in high schools, colleges and the Olympics. Nicholson had finally attained what he’d been striving toward for so long—only to have the offer rescinded when, as part of the WWE’s routine physical screening, he tested HCV positive. The journey had begun in a suburb of Ottawa, where, as a toddler, Nicholson came under the influence of a slightly
older friend his mother babysat who was obsessed with wrestling. “So I became obsessed with it too,” recalls the burly, deep-voiced Nicholson, who still lives in Ottawa. “I bought all the toys, and every time WWE came to the area, my parents had no choice but to take me,” he says. “I never thought it was anything but a show. I knew I wanted to be a wrestler. There was never anything else I considered.” In high school, Nicholson became an amateur wrestling champ, which led to offers from colleges. But his dream was to enter the high-glitz world of pro wrestling. So he moved to Calgary to train and ended up on the Canadian team before going on to wrestle professionally in Puerto Rico and elsewhere in the Caribbean. It was there, in fact, that he was christened “Hannibal,” after Dr. Hannibal Lecter from The Silence of the Lambs. “They wanted to put a mask on me like Anthony Hopkins, but they said I had a crazy-looking smile,” he says. Hence, no mask. It was then, after eight years in the business, that he got the WWE contract offer—and his HCV-positive diagnosis. He was convinced he contracted the virus from another wrestler, Larry “Abdullah the Butcher” Shreve, who was infamous for
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cutting his opponents with a razor. Nicholson said he’d never had a blood transfusion or injected drugs. Indeed, he had tested HCV negative shortly before being cut in the ring by Abdullah, who would cut himself with a razor and then immediately slice his opponents with it. With video to prove that, plus Abdullah’s medical records showing he’d had hep C for many years, Nicholson took Abdullah to court and in 2014 won his case, including $2.3 million in damages. The ringside bloodletting was allowed, says Nicholson, because pro wrestling in Canada is considered entertainment, not a sport, and hence not regulated as such. Despite the court win, Nicholson’s WWE dream was
dashed. Even worse, his first hep C treatment, the thenstandard interferon plus ribavirin, failed. “I was so depressed, living in a friend’s basement,” he says. “Those were the worst days of my life.” But he wouldn’t give up. He was working as a personal trainer at the time, and a client with a medical background in whom he confided his HCV diagnosis—“I wouldn’t tell anyone else because I thought they’d think I was a drug user,” he says—urged him to go public with it. “He thought that maybe someone would come out of the woodwork and help me,” recalls Nicholson. Several media outlets covered the story, kick-starting Nicholson’s new life as a hep C spokesperson. In 2012, he learned about the new HCV drug telaprevir, which Ottawa doctor Linda Scully, MD, agreed to put him on in addition to his old regimen. Because Canada did not cover the drug at the time, Nicholson used part of a 2012 court settlement to pay roughly $80,000 out of pocket. Once on the regimen, he experienced insomnia and unbearable itching—the latter a common side effect of telaprevir, which, having been outstripped by equally powerful new hep C drugs with little to no side effects, was discontinued in 2014. Nicholson had to stop working six weeks into the regimen. “But because I was public, making videos every week about my experience, I had other patients talking to me on Facebook at 4 a.m. for support.” To make matters worse, Scully extended his excruciating treatment from 24 to 36 weeks, just to be sure, but Nicholson made it out the other side. Six weeks later, he learned he was cured, a finding that several subsequent tests have confirmed. “I was so relieved,” he says, “because I was so paranoid it wasn’t going to work again.” Instantly, he started building his body back up, determined to return to pro wrestling. But, he says, he’s been rebuffed by WWE. “I think it’s the stigma of my having had hep C,” he says. Yet he has managed to start a new career chapter without WWE. He formed a production company that stages pro wrestling events in and around Canada and has even revived
“I was so relieved. Do whatever you can to get on treatment and get cured.”
his Hannibal character to compete in them. “I’ve had some of the best matches of my career” in recent years, he says. Nicholson keeps busy outside the ring too. First, there’s his YouTube channel, TheHannibalTV.com, which has more than 75,000 subscribers and millions of views and pulls in income with his interviews with pro wrestling legends. He has even embarked on an acting career and has had roles in commercials and several films. And he still works part-time at a city gym just because he loves it—especially interacting with children and toddlers. “Anyone who knows me knows I’m a pretty nice person in real life,” he laughs. As if all that weren’t enough, he’s now training to compete
professionally in mixed martial arts, a hybrid contact sport that allows striking and grappling. “I could have another five years there in a competitive environment,” he says. In his downtime, he travels and walks his dog, Piper, a miniature poodle, with his longtime partner, Laura PedneaultRoussel, who works in purchasing for the city of Ottawa and whom he credits with helping him through his worst times on hep C treatment. To folks out there living with HCV, he says, “Do whatever you can to get on treatment and get cured. And don’t be ashamed of it like I was.” He adds, “My life has been a roller coaster. But it’s proof that if you don’t give up on something, you can come out on top.” ■
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