First Drug for All Major Hepatitis C Genotypes Approved by FDA

The FDA today approved Epclusa to treat patients with chronic hepatitis C virus (HCV) with and without cirrhosis.

Gilead's Epclusa is a combination of sofosbuvir and the new drug velpatasvir. This is the first treatment approved to treat the 6 major genotypes of HCV.

“The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype,” Ira Jacobson, MD, principal investigator in the Epclusa clinical trials, said in a press release. “Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens.”

A phase 3 clinical trial that evaluated the treatment included 1558 patients without cirrhosis or with mild cirrhosis.

Researchers found that 95% to 99% of patients had viral suppression after 12 weeks. They also found that 94% of patients with moderate-to-severe cirrhosis had viral suppression after 12 weeks.

For patients with moderate-to-severe cirrhosis, Epclusa was approved in combination with ribavirin.

The most common side effects of the drug are headache and fatigue, according to the FDA.

“Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens,” said John Milligan, PhD, president and CEO of Gilead. “As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.”

Epclusa carries a warning for symptomatic bradycardia after incidents of pacemaker intervention were reported when amiodarone was administered with sofosbuvir in combination with another HCV direct-acting antiviral. The co-administration of amiodarone with Epclusa is not recommended.

Epclusa also carries a warning for use with certain drugs that may decrease the amount of Epclusa in the blood, leading to diminished efficacy.

“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.