Although liver failure and even fatalities could be linked to a potent drug combination that cures hepatitis C, don’t panic if you need the treatment.
Hepatitis C, a contagious virus that attacks the liver, causes a mild illness that lasts for only a few weeks in some people. But for the vast majority of those with the disease (75 to 85 percent), the infection persists. And this chronic form of hepatitis C can lead to serious and life-threatening liver problems, including cirrhosis (scarring of the liver) and liver cancer, according to the National Institutes of Health. Thankfully, there’s now a proven cure for the disease — but also new concerns about this treatment.
Although medications for chronic hepatitis C became available several years ago, they had worrisome side effects and were not very successful. Then new drugs came on the market gave new hope to the estimated 2.7 to 3.9 million Americans with the chronic infection. Combinations of antivirals approved by the Food and Drug Administration (FDA) over the past couple of years didn’t just help patients with hepatitis C. The medications made the majority of them well.
In 12 weeks and sometimes less, the successful combination of two antiviral drugs in particular, sofosbuvir (Sovaldi) and ledipasvir (Harvoni), resulted in what the National Institute of Diabetes, Digestive and Kidney Disease (NIDDK)calls a “bona fide cure for hepatitis C.“
“The newer hepatitis C drugs have been a godsend for many patients with chronic hepatitis C who are at risk of developing cirrhosis, liver failure, and liver cancer,” said Ryan M. Ford, MD, director of viral hepatitis transplant hepatology at the Emory Transplant Center. “Hepatitis C has traditionally been the number one cause for liver cancer and the need for liver transplantation in the United States.”
Taken in pill form, the new treatments for hepatitis C cure around 99 percent of those treated and avoid the many distressing side effects that accompanied earlier, interferon-based therapy, according to the NIDDK. However, despite all of this good news, a study has some raised potential red flags.
The non-profit Institute for Safe Medication Practices analyzed FDA reports of events that appeared linked to the medications from doctors around the world and concluded the groundbreaking hepatitis C cure may come with a heavy price for some people — severe liver damage and even death.
Approximately 250,000 people were treated with the newer drug combination in 2015 and, by the end of June in 2016, 524 had suffered liver failure; the condition was fatal for 165 of these patients. The study also found 1,058 other reports of severe liver damage and 761 cases where the drugs seemed to not be effective.
Although the doctors who sent these cases to the FDA were concerned the hepatitis drugs caused the liver damage and deaths, there isn’t specific evidence the drugs were to blame. In fact, the report doesn’t include the patients’ medical histories so it’s unknown if their lifestyle (such as other drug use) played a role in their additional health problems.
In an interview with The New York Times, Robert S. Brown, MD, director of the Center for Liver Disease and Transplantation at NewYork-Presbyterian at Columbia and Weill Cornell, noted some of the serious problems documented in the Institute for Safe Medication Practices report could be the result of doctors prescribing the drugs for patients who were too ill to tolerate them.
“There is a huge upside to treating and curing patients with chronic hepatitis. That being said, patients with advanced liver disease should be monitored closely during therapy,” said Emory hepatitis C expert Ford.
“We have treated over 1,000 patients in the last several years here at Emory, and we have not observed any deaths related to the new hepatitis C therapy. Some patients who develop decompensation of liver disease may be following the natural history of their disease, and we have to be careful when making associations with the new hepatitis drugs,” he explained. “I do agree that reactivation of hepatitis B has been a documented concern as of late. Further study is required to see if HCV cure has any negative effect on patients with liver cancer. ”
It’s not unusual for previously unknown side effects to show up in some people after large numbers take medications over time, despite drugs being tested and approved for safety — so experts agree more investigation of the potential downside of the hepatitis C drugs is needed. Meanwhile, there’s no reason for hepatitis patients to panic or forego needed treatment.
"The risk of severe side effects from the newer anti-viral treatments for hepatitis C is fortunately relatively small,” said Sharon Horesh Bergquist, MD, Rollins distinguished clinician and Emory School of Medicine assistant professor. “More work needs to be done to determine if the reported adverse effects are directly caused by the drugs. Anyone currently taking or considering these medications should discuss their personal benefit versus potential side effects with their doctor.”
Another serious concern about the drugs doesn’t involve health but price — $55,000 to $ 155,000 per patient. But considering the breakthrough hepatitis C treatment is curative and often lifesaving, it may end up being a bargain for the majority of patients who are successfully treated and no longer have to live with a chronic and potentially deadly disease.
Hepatitis C infection does not always produce symptoms until the liver is seriously damaged. The CDC recommends being tested for the virus if you have any risk factors including being born between 1945 and1965, contact with infected blood (including blood transfusions prior to 1992), drug use involving needles, and sexual contact with an infected person.
Visit the CDC hepatitis C page for more information on risk factors, testing and treatment for the virus.
February 10, 2017
Christopher Nystuen, MD, MBA