FDA Approval for Gilead's New Treatment for HCV

A combination of sofosbuvir and velpatasvir (Epclusa) that is effective against all 6 major forms of the hepatitis C virus (HCV) has received the FDA’s consent to market.

The treatment, developed by Gilead Science’s Inc, is approved for adults with chronic HCV infection, with and without cirrhosis. Patients who have moderate to severe cirrhosis, also known as decompensated cirrhosis, need to include ribavirin in their regimen.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Sofosbuvir, a polymerase inhibitor, was initially developed for use in combination with peginterferon and ribavirin for the treatment of patients infected with genotypes 1 or 4 of HCV, and with ribavirin alone for use in patients with genotype 2 and 3. Additionally, the combination of sofosbuvir with daclatasvir (Daklinza) has been approved for patients with genotype 3 infections, and the treatment regimen is free of interferon and ribavirin. In the United States, about 75% of those infected with HCV have genotype 1, 2-%-25% have genotypes 2 or 3, and a very small fraction have genotypes 4, 5, or 6.

According to the FDA release, safety and efficacy results of Epclusa were reported based on 3 12-week phase 3 trials conducted in over 1500 individuals without cirrhosis or with compensated cirrhosis. The virus could no longer be detected in 95%-99% of patients 12 weeks following treatment. In 267 patients with decompensated cirrhosis, 94% of patients treated with Epclusa had no detectable levels of HCV in their bloodstream at 12 weeks following treatment.

Headache and fatigue were the most commonly reported side effects of the treatment. Additionally, individuals for whom ribavirin is contraindicated should undergo this treatment. A drug-drug interaction between amiadarone, sofosbuvir, and another HCV-directed antiviral has been reported, which can result symptomatic bradycardia and might need pacemaker intervention. The label also carries a warning on other drug-drug interactions that could reduce the bioavailability of Epclusa.

The drug is expected to cost $74,760 for 12 weeks.