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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
UNITED STATES: Olysio, New Hepatitis C Therapy, Approved by FDA
Staff Writer
February 5, 2014
Gastroenterology & Endoscopy News (02.04.2014) Aids Weekly Plus

Gastroenterology & Endoscopy News reported that the US Food and Drug Administration (FDA) recently approved Janssen Therapeutics’ Olysio (simeprevir) to treat adults with chronic hepatitis C virus (HCV) genotype 1 infection. The drug is used in combination with pegylated interferon-alfa (PEG-IFN) and ribavirin to tend treatment-naïve patients and patients who did not respond to previous therapy. According to Edward Cox, MD, director of the Office of Antimicrobial Products at the FDA’s Center for Drug Evaluation and Research, this is the third FDA-approved protease inhibitor for treating chronic HCV. As part of the approval, the FDA cited safety and efficacy data from more than 2,000 patients in placebo-controlled clinical trials with treatment-naïve and relapsed patients or those for whom earlier PEG-IFN treatment had failed. The participants received PEG-IFN, ribavirin, and simeprevir; or placebo. In the trials, a higher percentage of patients treated with simeprevir achieved sustained virologic response compared with the control group. The most common side effects were itching, nausea, and skin rash. Some participants experienced severe photosensitivity and had to be hospitalized. The FDA cautions pregnant women or those planning to become pregnant not to take simeprevir. It also requires physicians to screen patients for NS3 Q80K polymorphism before beginning treatment, as the drug efficacy is reduced in patients with HCV genotype 1a and this polymorphism. Physicians should use a different HCV therapy for these patients.

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