FDA Approves Single-Tablet HCV Regimen

The Food and Drug Administration (FDA) has approved Vosevi (sofosbuvir, velpatasvir, voxilaprevir; Gilead) for the retreatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis who were previously treated with an NS5A inhibitor-containing regimen or in adults with genotype 1a or 3 who were previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

Vosevi combines sofosbuvir, a HCV NS5B polymerase inhibitor, velpatasvir, a HCV NS5A inhibitor, with voxilaprevir, a pangenotypic NS3/4A protease inhibitor.

The approval of Vosevi is supported by data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotypes 1a and 3 with or without compensated cirrhosis who had failed prior treatment with a sofosbuvir-containing regimen that did not include an NS5A inhibitor. 

Data from both studies showed that 96–97% of Vosevi-treated patients had no virus detection in the blood 12 weeks after completing treatment (SVR12), suggesting cure of infection. The most frequent adverse reactions associated with Vosevi were headache, fatigue, diarrhea, and nausea. Less than 1% (0.2%) of patients who received Vosevi permanently discontinued treatment due to adverse events. 

Vosevi carries a Boxed Warning regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV co-infected patients. 

Vosevi will be available as 400mg/100mg/100mg strength fixed-dose tablets.

Reference

US Food and Drug Administration approves Gilead’s Vosevi™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for re-treatment of adults with chronic hepatitis C virus [press release]. Foster City, California: Gilead. Published July 18, 2017. Accessed July 24, 2017.

This article originally appeared on MPR