The FDA today approved Gilead Sciences' sofosbuvir and velpatasvir (Epclusa) for the treatment of adult patients with chronic hepatitis C virus both with and without cirrhosis.
The FDA today approved Gilead Sciences’ sofosbuvir and velpatasvir (Epclusa) for the treatment of adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis.
The agency also permitted the drug to be used in combination with ribavirin in patients with moderate to severe cirrhosis.
Gilead initially filed the new drug application (NDA) for Epclusa in October 2015; this NDA was later granted priority review status in January 2016.
Notably, the drug is the first and only FDA-approved HCV treatment able to treat all 6 major genotypes.
“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 FDA’s Office of Antimicrobial Products, in a press release.
The FDA based its nod on the results of 3 late-stage trials in which the safety and efficacy of Epclusa were evaluated in a total of 1558 HCV patients without cirrhosis or with mild cirrhosis. Researchers found no traces of virus in the blood of 95% to 99% of patients who received the drug, indicating that these participants’ infections had been cured.
In an additional clinical trial, the use of Epclusa was associated with the elimination of the virus in 94% of patients with moderate-to-severe cirrhosis.
Adverse events reported by trial participants treated with Epclusa include headache and fatigue. The FDA recommended against taking the drug alongside amiodarone, as serious slowing of the heart rate and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral.