The FDA announced on July 18 that it has approved a new drug combination to treat adults with chronic hepatitis C virus (HCV) genotypes 1 through 6 who have mild or no cirrhosis.
The fixed-dose tablet, Vosevi, combines the previously approved drugs sofosbuvir and velpatasvir with a new drug, voxilaprevir. It is the first treatment approved for patients who have been previously treated with sofosbuvir or other HCV drugs that inhibit nonstructural protein 5A (NS5A). Its safety and efficacy were tested in two clinical trials of about 750 adults with mild or no cirrhosis.
The first trial compared 12 weeks of placebo versus treatment with the drug in adults with HCV genotype 1 who had previously had treatment failure with an NS5A inhibitor, whereas patients with other genotypes all received the drug. The other trial compared 12 weeks of the new combination drug with sofosbuvir and velpatasvir in participants with HCV genotypes 1, 2, and 3 who had previously had treatment failure with sofosbuvir but not an NS5A inhibitor.
Overall, 96% to 97% of patients who received the new combination drug had no virus detected in their blood 12 weeks after completing treatment. Treatment recommendations for the drug vary based on the patient's viral genotype and treatment history. Due to concerns about hepatitis B virus (HBV) reactivation in co-infected patients, clinicians should screen for current or prior HBV infection before starting treatment with Vosevi, according to the FDA.
The most common adverse reactions in patients taking the drug were headache, fatigue, diarrhea, and nausea. The drug is contraindicated in patients taking rifampin.