Gilead's Sovaldi-based combination therapy for hepatitis C has been cleared for use by the US Food and Drug Administration to treat all six types of the virus, potentially eliminating the need for genotype testing.
Epclusa - a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (approved as Sovaldi) and the pan-genotypic NS5A inhibitor velpatasvir - is the first all-oral, pan-genotypic, single tablet regimen cleared for the treatment of adults with genotype 1-6 chronic HCV.
It is also the first single tablet regimen cleared to treat patients with HCV genotype 2 and 3, without the need for ribavirin.
Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin for patients with decompensated cirrhosis (Child-Pugh B or C).
Clearance comes after data from the Phase III ASTRAL trials showed that, of the 1,035 patients treated with the combination for 12 weeks - 21 percent of which had compensated cirrhosis and 28 percent of which had failed prior treatments - 98 percent achieved the primary efficacy endpoint of a sustained virologic response.
"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," said Ira Jacobson, chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Epclusa clinical trials.
"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."
Epclusa is also currently being reviewed by regulators in Europe, where it recently won support for approval from the European Medicines Agency's Committee for Medicinal Products for Human Use.