FDA Approves HCV Treatment Vosevi for Previously Treated Patients

The FDA recently approved Vosevi—a fixed-dose combination tablet containing FDA-approved sofosbuvir and velpatasvir, and a new drug, voxilaprevi—to treat adults with the hepatitis C virus (HCV) who do not have cirrhosis (liver disease).

Vosevi will be the first approved treatment for patients who have been treated with the direct-acting antiviral drug sofosbuvir or any other treatment that targets the NS5A protein.

“Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past.”

The FDA approval includes the treatment of hepatitis C genotypes 1-6 that are genetically distinct versions of the virus. Approximately, 75% of Americans with HCV have genotype 1; 20% to 25% have genotypes 2 or 3; and the small number of remaining patients have genotypes 4, 5, or 6. By identifying the genotype, more specific treatment recommendations of Vosevi can be made.

Approximately 750 adults with the HCV participated in two Phase 3 clinical trials in order to test the safety and effectiveness of Vosevi. The first trial, over the course of 12 weeks, compared genotype 1 patients, who received a placebo and had previously received an unsuccessful NS5A inhibitor, with patients with genotype 2, 3, 4, 5 or 6 who all received Vosevi. The second trial included a comparison of Vosevi and the previously approved drugs sofosbuvir and velpatasvir in patients with genotypes 1, 2, or 3 who had an unsuccessful treatment with sofosbuvir.

The trial revealed 96% to 97% of patients who received Vosevi had no detection of the virus at 12 weeks following the treatment—demonstrating a potential cure.