HealthDay News — The FDA has approved simeprevir (Olysio, Janssen) as a treatment for adults with chronic hepatitis C infection.
The new drug is indicated for use with two other antiviral medications — peginiterferon-alfa and ribavirin — in patients with cirrhosis but whose liver is still functioning, those who haven’t been treated for hepatitis C previously and those who haven’t responded to other therapies. It should not be administered by itself, the FDA specified.
“[Simeprevir] is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research said in a press release.
Simeprevir’s approval was based on results from five clinical studies involving 2,026 patients that showed that simeprevir plus peginterferon-alfa and ribavirin was safe and effective.
Study results indicated 80% of treatment-naive participants assigned to simeprevir plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared with 50% assigned to placebo (peginterferon-alfa and ribavirin alone).
In one of the studies with treatment-experienced participants whose infection returned (prior relapsers), 79% in the treatment group achieved sustained virologic response compared with 37% of controls.
Common side effects included rash, itching and nausea. Noting the potential for serious reactions involving light exposure, the FDA is warning patients to avoid the sun and to use sunscreen and other protective measures during treatment.