Combination treatment for hepatitis C approved by FDA
The US Food and Drug Administration (FDA) has approved the use of the combination treatment Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis.
Vosevi is a fixed-dose, combination tablet containing two previously approved drugs, sofosbuvir and velpatasvir, and a new drug, voxilaprevir. It is the first treatment to be approved for patients who have previously been treated with sofosbuvir or other HCV drugs that work by inhibiting a protein called NS5A.
FDA Center for Drug Evaluation and Research Office of Antimicrobial Products director, Edward Cox, said: “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.”
The safety and efficacy of Vosevi was evaluated in two phase III clinical trials that enrolled around 750 adults without cirrhosis or with mild cirrhosis. In both trials, it was found that 96–97% of patients who received the combination drug had no virus detected in the blood 12 weeks after finishing treatment, suggesting a cure.
The most common adverse reactions of Vosevi included headache, fatigue, diarrhoea and nausea, and it is contraindicated in patients taking rifampin.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203228
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