The FDA has approved Gilead Sciences’ Vosevi for the treatment of adults with chronic hepatitis C virus genotypes 1-6, without cirrhosis or with mild cirrhosis.
Those with chronic hepatitis C virus (HCV) genotypes 1-6 (with mild cirrhosis or without cirrhosis) now have a new treatment option. The US Food and Drug Administration (FDA) just approved a new treatment option: Gilead Sciences’
fixed-dose, combination tablet,
The Centers for Disease Control and Prevention (CDC) estimates that a staggering 2.7 to 3.9 million individuals in the United States suffer from chronic HCV. With new infections occurring every day—particularly in light of the ongoing opioid epidemic—a new treatment option is particularly welcome.
Vosevi is a combination 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,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research commented in the statement.
Vosevi’s safety and efficacy were evaluated in two phase 3 clinical trials that enrolled around 750 adults with mild cirrhosis or without cirrhosis at all.
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.
In both trials, the majority of patients (96% to 97%) who took Vosevi had no detectable virus in their blood 12 weeks after finishing treatment, suggesting that the patients’ infection had been cured.
Vosevi is contraindicated for patients taking the drug rifampin. The most common adverse reactions were headache, fatigue, diarrhea and nausea.