FDA Approves Vosevi for Hepatitis C Patients Who Failed Earlier Treatments

New single-tablet regiment indicated for genotypes 1 to 6

A new weapon in the arsenal of hepatitis C treatments seeks to help patients whose disease has so far resisted a cure, according to Gilead Sciences.

The FDA has approved Vosevi, a fixed-dose, single-tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg. It’s indicated for the retreatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The FDA approval covers adults without cirrhosis or with mild cirrhosis.

“Direct-acting antiviral [DAA] regimens have transformed HCV treatment and have allowed health care providers the fortunate opportunity to cure many patients. However, for patients who require retreatment, there remains an unmet clinical need for an effective and well-tolerated option,” said Ira Jacobson, MD, Chairman of the Department of Medicine at Mount Sinai Beth Israel in New York City and a principal investigator in the Vosevi clinical trials. “Treatment with Vosevi resulted in high cure rates in clinical studies of patients who were not previously cured with several widely-prescribed DAA regimens and will provide physicians with an important new therapeutic option that could offer hope for their hardest-to-treat patients.”

Vosevi contains the previously approved drugs sofosbuvir and velpatasvir and a new drug, voxilaprevir.

The approval of Vosevi is supported by data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1–6 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. In these populations across the two studies, 340 of the 353 patients treated with Vosevi (96%) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

The most common adverse events (at least 10% of patients) among patients who received Vosevi were headache, fatigue, diarrhea, and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2% for subjects who received Vosevi for 12 weeks.

Approximately 75% of Americans with HCV have genotype 1; 20–25% have genotypes 2 or 3; and a small number of patients are infected with genotypes 4, 5 or 6.

Vosevi has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients.

Sources: Gilead Sciences; July 18, 2017; FDA; July 18, 2017