FDA Approves Hep C Drug

The FDA today granted approval for Vosevi to treat adult patients with chronic hepatitis C virus (HCV) genotypes 1 to 6 without cirrhosis or mild cirrhosis.

Vosevi is a fixed-dose, combination tablet containing sofosbuvir and velpatasvir, as well as the new drug voxilaprevir, according to a press release.

The approval was based on safety and efficacy data of Vosevi in 2, phase 3 clinical trials that included approximately 750 adults with mild cirrhosis or without cirrhosis.

The first 12-week trial compared Vosevi with placebo in adults with HCV genotype 1 who previously failed treatment with an NS5A inhibitor. Patients with genotypes 2, 3, 4, 5, or 6 all received Vosevi, according to the release.

In the second trial, investigators examined Vosevi versus sofosbuvir and velpatasvir in adults with HCV genotypes 1, 2, or 3 who previously failed treatment with sofosbuvir, but not an NS5A inhibitor drug.

The results of both clinical trials showed that 96% to 97% of patients administered Vosevi had no viral detection 12 weeks after treatment, suggesting that the infection had been cured, according to the release.

The most common adverse events observed with Vosevi were headache, fatigue, diarrhea, and nausea.

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

Recommendations for Vosevi vary depending on a patient’s viral genotype and prior treatment history. Approximately 75% of Americans with HCV have genotype 1; 20% to 25% have genotypes 2 or 3, respectively; and a small proportion of patients have genotypes 4, 5, or 6.