The drug was granted priority review and breakthrough therapy status by the FDA.
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Vosevi for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis.
The drug is an amalgamation of 2 previously approved drugs — sofosbuvir and velpatasvir – plus a new drug called voxilaprevir. It is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir, or other drugs for HCV that inhibit NS5A proteins, the FDA said in a statement.
The drug was given priority review, which is granted to drugs that, if approved, would markedly improve the safety or efficacy of a treatment of a serious condition. It was also given breakthrough therapy status, which is granted to drugs that could demonstrate a substantial improvement over available therapies.
“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,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Vosevi’s safety and efficacy were evaluated in 2 phase 3 clinical trials that enrolled about 750 adults without cirrhosis or with mild cirrhosis.
In both trials, 96-97% of patients who took Vosevi had no detectable virus in their blood 12 weeks after finishing treatment, suggesting that the patients’ infection had been cured.
The first trial compared 12 weeks of Vosevi treatment with placebo in adults with genotype 1 who had previously failed treatment with an NS5A inhibitor drug. Patients with genotypes 2, 3, 4, 5, or 6 all received Vosevi.
The second trial compared 12 weeks of Vosevi treatment with the previously approved drugs that comprise two thirds of Vosevi’s makeup — sofosbuvir and velpatasvir – in adults with genotypes 1, 2 or 4 who had previously failed treatment with sofosbuvir but not an NS5A inhibitor drug.
Vosevi is contraindicated for patients taking the drug rifampin. The most common adverse reactions were headache, fatigue, diarrhea and nausea.
According to the Centers for Disease Control and Prevention (CDC), an estimated 2.7 to 3.9 million people in the United States have chronic HCV. There are at least 6 distinct HCV genotypes, which are genetically distinct groups of the virus. Knowing the strain of the virus can help inform treatment recommendations, the statement read.