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FDA approves drug for hepatitis C

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FDA approved on July 18 a fixed-dose combination tablet (Vosevi—Gilead Sciences) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis. The treatment contains two previously approved drugs—sofosbuvir and velpatasvir—as well as a new drug, voxilaprevir.

FDA approved on July 18 a fixed-dose combination tablet (Vosevi—Gilead Sciences) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis. The treatment contains two previously approved drugs—sofosbuvir and velpatasvir—as well as a new drug, voxilaprevir. The combination drug is the first treatment approved for patients who have been previously treated with sofosbuvir or other drugs for HCV that inhibit the NS5A protein. "Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past," said Edward Cox, MD, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. Two Phase III clinical trials involving about 750 adults without cirrhosis or with mild cirrhosis were used to demonstrate the safety and efficacy of sofosbuvir–velpatasvir–voxilaprevir. According to the results of the trials, 96%–97% of patients who received the treatment had no virus detected in the blood 12 weeks after completing treatment, suggesting that the patients' HCV infection had been cured. The most frequent adverse reactions in patients taking sofosbuvir–velpatasvir–voxilaprevir were headache, fatigue, diarrhea, and nausea.

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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm

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