Most With Hepatitis C May Soon Find Hope in New Treatments
WEDNESDAY, Jan. 15, 2014 -- Hepatitis C treatment isn't pretty, but the dark days of weekly injections, rough side effects and no guarantee of full recovery from the liver-damaging disease may soon be over, researchers report.
Two studies, both published in the Jan. 16 issue of the New England Journal of Medicine, involved giving various combinations of antiviral pill cocktails to patients with hepatitis C. Some had failed to respond to standard treatments, and some had not received treatment yet. Yet, the cocktails cleared the virus in both studies for between 93 percent and 98 percent of the patients.
These cocktails are game-changers for the illness, said Andrew Muir, director of gastroenterology and hepatology research at the Duke Clinical Research Institute.
"This has made me change the way I'm talking with patients. These regimens are essentially going to cure everybody," said Muir, who has conducted related research but did not participate in these studies. "I had a patient in my office this morning who said, 'If I get cured,' and I said to him, 'When you get cured,'" Muir added.
"I think the great thing about these new direct-acting antivirals is that with the right combinations of drugs, all patients appear to be cured," said Muir.
The first study, conducted by Johns Hopkins researchers, included 211 men and women with hepatitis C who took two pill-form antiviral medications, daclatasvir and sofosbuvir. The patients were treated at 18 medical centers in the United States and Puerto Rico. They took 60 milligrams of daclatasvir and 400 milligrams of sofosbuvir for either 12 or 24 weeks, with or without a third drug, ribavirin.
The scientists reported that the experimental drugs were safe and effective in the patients, even those who'd had earlier standard therapy for hepatitis C virus -- interferon shots and two other medications.
"We saw a very high response rate in those who got the two [new] medications. This study paves a path forward for interferon-free regimens. These drugs are potentially highly effective and tolerable," said study author Dr. Mark Sulkowski, medical director of the Johns Hopkins Center for Viral Hepatitis.
Sulkowski said 98 percent of the 126 previously untreated patients and 98 percent of 41 patients whose infections had not cleared despite treatment with standard hepatitis C therapy, were considered cured. "There was no detectable virus in their blood three months after the treatment stopped," he noted.
The U.S. Food and Drug Administration approved sofosbuvir in combination with peginterferon and ribavirin this past December for one form of hepatitis C, and daclatasvir is still in the approval process, Sulkowski said.
According to the U.S. Centers for Disease Control and Prevention, 3.2 million people in the United States have chronic hepatitis C infection. The virus is silent early on, but over two or three decades it can lead to severe liver damage, sometimes requiring a liver transplant. It's the leading cause of liver transplants in the United States.
Up until now, injectable interferon has been the key form of treatment, usually combined with antiviral medications, said Sulkowski, but many patients can't tolerate the side effects of the interferon, which can include flu-like symptoms, nausea, fatigue, anxiety and depression.
The second study, headed up by researchers at Virginia Mason Medical Center in Seattle, involved more than eight medical centers in the United States and internationally. It included 571 patients with hepatitis C, some of whom had not received treatment previously and others who had previously received standard treatments with interferon injections and ribavirin -- an antiviral drug that when given reduces relapses -- but had not responded to them.
The participants were randomly assigned to take any of three combinations of antiviral pills -- medications called ABT-450, ABT-267, and ABT-333 -- for eight, 12 or 24 weeks.
Almost all of the patients (more than 93 percent in both groups) saw the virus cleared from their systems within 24 weeks, said lead author Dr. Kris Kowdley, director of the liver center of excellence in the Digestive Disease Institute at Virginia Mason.
"Even in patients with prior no-response, a difficult-to-treat population with interferon, this all-oral regimen for 12 weeks can achieve a cure in the vast majority of patients. It is safe and well-tolerated," said Kowdley. "It really changes the paradigm for treatments."
Dr. Anna Lok, director of clinical hepatology at the University of Michigan Medical School, and a co-author on the Hopkins study, said, "These two regimens have excellent safety profiles." But she noted, the drugs are expensive, up to thousands of dollars per treatment course.
"Cost is an issue, and will make these treatments not accessible to many patients," said Lok.
Drug makers funded both studies, but Lok noted, "They scrutinize the data carefully and these data will be scrutinized by the FDA also, so I would trust the data presented."
Muir said the next step is to keep pushing for better hepatitis C screening, so that patients can receive treatments before their livers fail. "Anybody we can catch when they have stable liver disease, we can help," he said.
Visit the U.S. National Library of Medicine for more on hepatitis C.
Posted: January 2014