Pharma Marking – FDA Approves Vosevi For Hepatitis C

The FDA has recently given approval to Gilead Sciences for the use of the company’s Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets to re-treat adults who suffer from chronic hepatitis C virus infection, or HCV.

According to reports, the single-tablet regimen is effective in most patients; two studies supported the claim that about 96% of patients involved in these studies who were treated with the drug achieved the primary endpoint of SVR12. SVR stands for ;sustained viral response,’ and the number following the abbreviation indicates the minimum number of weeks hepatitis C remains undetectable following the end of treatment.

The U.S. Food and Drug Administration approved Vosevi based on data from POLARIS-1 and POLARIS-4 studies. These 12-week studies involved patients with chronic hepatitis C virus infection, including those who do not have cirrhosis and those with compensated cirrhosis.

John Milligan, CEO and President at Gilead said, “The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible.”

The three ingredients in Vosevi (sofosbuvir, velpatasvir, voxilaprevir) are direct-acting antiviral agents; this is the first time the FDA has given approval of any form of voxilaprevir. According to the FDA’s Center for Drug Evaluation and Research Office of Antimicrobial Products Director, Edward Cox, MD direct-acting antiviral drugs work by preventing the hepatitis C virus from multiplying, and frequently cure HCV.

The three-drug combo will hopefully be successful in patients whose first line of treatment didn’t work.

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