Epclusa receives FDA approval for HIV/HCV coinfection in all genotypes
Gilead Sciences announced the FDA approval of Epclusa for the treatment of hepatitis C genotypes 1 through 6 in patients coinfected with HIV, according to a press release.
“Epclusa has already helped further simplify HCV treatment among mono-infected patients, and we are pleased that HCV/HIV coinfected patients can benefit from this pan-genotypic single tablet regimen,” John F. Milligan, PhD, president and CEO of Gilead Sciences, said in the release. “This approval advances the commitment we’ve made to the HCV and HIV communities to deliver innovative new treatments that address their unmet medical needs.”
Epclusa (sofosbuvir/velpatasvir) previously received regulatory approval for treating adults with HCV genotypes 1 through 6 without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin on June 28, 2016.
The safety profile of Epclusa for HIV/HCV coinfected patients was like that observed in patients with HCV, according to study results. Common adverse events included fatigue and headache. The drug’s label includes a warning regarding the risk for hepatitis B reactivation in HCV/HBV coinfected patients.