FDA Clears Pan-Genotypic Vosevi for Chronic Hepatitis C

Megan Brooks


July 18, 2017

The US Food and Drug Administration (FDA) today approved Vosevi (Gilead Sciences) to treat adults with chronic hepatitis C virus (HCV) genotypes 1 through 6 without cirrhosis or with mild cirrhosis.

Vosevi is a once-daily single tablet that contains two previously approved drugs — the nucleotide analog nonstructural protein NS5B polymerase inhibitor sofosbuvir (400 mg) and the HCV NS5A inhibitor velpatasvir (100 mg) — and the newly approved pan-genotypic HCV NS3/4A protease inhibitor voxilaprevir (100 mg).

Vosevi is the first FDA-approved treatment for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit NS5A, the FDA said in a new release. 

The FDA granted Vosevi breakthrough therapy designations and priority review.

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

The safety and efficacy of Vosevi were evaluated in two phase 3 clinical trials that enrolled about 750 adults without cirrhosis or with mild cirrhosis.

The first trial compared 12 weeks of Vosevi treatment with placebo in adults with genotype 1 in whom treatment with an NS5A inhibitor had previously failed. Patients with genotypes 2, 3, 4, 5, or 6 all received Vosevi.

The second trial compared 12 weeks of Vosevi with sofosbuvir and velpatasvir in adults with genotypes 1, 2, or 3 in whom treatment with sofosbuvir, but not an NS5A inhibitor, had failed.

Results of both trials demonstrated that 96% to 97% of patients who received Vosevi had sustained viral response at 12 weeks, the FDA said.

The most common adverse reactions in patients taking Vosevi were headache, fatigue, diarrhea, and nausea.  The proportion of patients who permanently discontinued treatment because of adverse events was 0.2% for those who received Vosevi for 12 weeks.

Vosevi is contraindicated in patients taking the drug rifampin.

The FDA notes that patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation when taking direct-acting antivirals HCV infection.  The agency requires boxed warning for the drugs advising clinicians to screen patients for evidence of a past or current HBV infection before ordering antiviral treatment for HCV.

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