General Information

Vosevi is specifically indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1, 2, 3, 4, 5 or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor or genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

Side Effects

Adverse effects associated with the use of Vosevi may include, but are not limited to, the following:

Headache

Fatigue

Diarrhea

Nausea

The Vosevi label comes with a black box warning of the risk of hepatitis B virus reactivation in patients co-infected with HCV and HBV.

Dosing/Administration

Vosevi is supplied as a tablet for oral administration. Prior to the initiation of therapy, all patients should be tested for HBV infection by measuring HBsAg and anti-HBc. The recommended dosage is one tablet (400 mg of sofosbuvir, 100 mg of velpatasvir and 100 mg of voxilaprevir) taken orally once daily with food for 12 weeks.

Clinical Trial Results

FDA Approval

The FDA approval of Vosevi was based on four phase 3 studies. Two studies (POLARIS-1 and POLARIS-4) evaluated 12 weeks of the single tablet regimen in patients with hepatitis C genotypes 1-6 previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated eight weeks of Vosevi in DAA-naïve patients with hepatitis C genotypes 1-6. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with Vosevi (n=431/445) achieved the primary efficacy end point of SVR12. In POLARIS-2, 95 percent of patients with hepatitis C genotypes 1-6 with and without cirrhosis treated with Vosevi (n=477/501) achieved the primary efficacy end point of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and compensated cirrhosis treated with Vosevi (n=106/110) achieved the primary efficacy end point of SVR12.