Gilead Sciences Inc.'s updated labeling for Epclusa has been approved by the U.S. Food and Drug Administration.
Epclusa is an all-oral, pan-genotypic, once-daily single tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) infection. The updated labeling allows the drug to be used on patients co-infected with HIV.
“HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded use, Epclusa provides co-infected patients with a much needed one-pill-a-day regimen that works across all HCV genotypes and is compatible with widely-used antiretroviral regimens,” David Wyles, chief of the Division of Infectious Disease at the Denver Health Medical Center, said in a statement. “With Epclusa, physicians have an important new treatment option for their HCV/HIV co-infected patients.”
Gilead first received regulatory approval for Epclusa in June 2016. The drug was then used to treat adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin.
“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,” Dr. John Milligan, Gilead’s president and CEO, said.
With the new approval, the company noted the drug carries a risk of reactivating hepatitis B virus (HBV) in HCV/HBV co-infected patients.