Posted by Michael Wonder on 03 Aug 2017
U.S. FDA approves expanded labeling for Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C in patients co-infected with HIV
1 August 2017 - New data for first approved pan-genotypic once-daily single tablet regimen for chronic hepatitis C virus infection.
Gilead today announced that the U.S. FDA has approved updated labeling for Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen for the treatment of adults with chronic hepatitis C virus infection, to include use in patients co-infected with HIV.
Epclusa received regulatory approval for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin, in the United States on 28 June 2016.
The supplemental new drug application was supported by data from the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of treatment with Epclusa in 106 subjects with genotype 1-4 HCV infection who were co-infected with HIV and on stable antiretroviral therapy. In the study, 95% (101/106) of patients achieved the primary endpoint of SVR12, defined as an undetectable viral load 12 weeks after completing therapy.
