New Treatment for Hepatitis C Infection Approved
Olysio may cut down on side effects while achieving good responses in patients, experts say
Another expert was optimistic about the treatment.
Olysio "is an important new addition to the hepatitis C virus treatment regimens, offering improved efficacy, easier administration with once-a-day dosing and an improved side effect profile," said Dr. David Bernstein, chief of the division of hepatology at North Shore University Hospital in Manhasset, N.Y.
The clinical trials for Olysio also found that patients with a specific strain of the hepatitis C virus commonly found in the United States were less likely to respond to treatment with the drug. The drug's label therefore tells doctors to screen patients for the presence of this strain before beginning treatment with Olysio and to consider other treatments for patients with this strain.
Common side effects among patients who took the three-drug combo included sensitivity to light, itching and nausea. Some patients had severe light sensitivity that required hospitalization. Patients will be advised to limit their sun exposure and to use sun protective measures when taking Olysio with peginterferon-alfa and ribavirin, the FDA said.
Dieterich believes that patients now have more options than ever before in treating hepatitis C infection.
The approval of Olysio "represents the first once-daily protease inhibitor, which when used with interferon and ribavirin, has about an 80 percent success rate in curing hepatitis C in 24 weeks," he said. "This could be the beginning of the end for hepatitis C, if everyone that has it gets tested and treated, as the CDC recommends for baby boomers."
Olysio is marketed by Janssen Pharmaceuticals.