Adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis can now be prescribed Epclusa. The Food and Drug Administration approved the fixed-dose combination tablet is the first treatment that controls genotypes 1-6 of HCV.
“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.
Epclusa, which contains sofosbuvir and velpatasvir, is manufactured by Gilead Sciences, located in Foster City, Calif. Before approval, the drug was evaluated for 12 weeks in three phase III clinical trials that included 1,558 patients diagnosed without cirrhosis and patients with compensated cirrhosis. Twelve weeks after finishing treatment, 95%-99% of patients who received Epclusa had no signs of infection. Epclusa cured the condition, which means no sign of the virus was detected in any of the patients’ blood. In addition, 267 patients were studied for the safety and efficacy of Epclusa, 87 of whom took Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detected in the blood 12 weeks after finishing treatment.
Side effects of Epclusa include headache and fatigue. Epclusa also carries a warning not to use with certain drugs that may reduce the effective amount of Epclusa.