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Vosevi (sofosbuvir, velpatasvir, and voxilaprevir)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved July 2017

Specific Treatments:

hepatitis C

General Information

Vosevi is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, velpatasvir, an HCV NS5A inhibitor, and voxilaprevir, an HCV NS3/4A protease inhibitor.

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. 

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 a duration of 12 weeks.

Clinical Results

FDA Approval

The FDA approval of Vosevi was based on four Phase III 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 8 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 endpoint 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 endpoint 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 endpoint of SVR12.

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. 

Mechanism of Action

Vosevi is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, velpatasvir, an HCV NS5A inhibitor, and voxilaprevir, an HCV NS3/4A protease inhibitor.

Additional Information

For additional information regarding Vosevi or hepatitis C, please visit http://www.vosevi.com/

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