Epclusa - a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF/VEL; 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.
The combination of SOF/VEL for 12 weeks was authorised for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).
It is also the first single tablet regimen licensed for the treatment of patients with HCV genotype 2 and 3, without the need for RBV, said Gilead, noting that physicians may consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.
The therapy's green light follows an accelerated review procedure by the European Medicines Agency, and comes on the back for data from the Phase III ASTRAL trials, which 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.
"SOF/VEL offers an effective and generally tolerable choice which is ribavirin free for the majority of patients. For the first time we have a once-daily single tablet treatment option which works across all genotypes including genotype 3, which is often the least responsive to treatment," said Professor William Rosenberg, clinical lead for Viral Hepatitis, UCL Institute for Liver and Digestive Health, London.