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FDA Expands Labeling for Epclusa® to Include Co-Infected Patients with HCV/HIV and Warning for HBV Reactivation

August 9, 2017
FDA Expands Labeling for Epclusa® to Include Co-Infected Patients with HCV/HIV and Warning for HBV Reactivation

The U.S. Food and Drug Administration (FDA) has approved expanded labeling for Epclusa®, a combination therapy for adults with chronic hepatitis C viral (HCV) infection. Manufactured by Gilead Sciences, Inc., Epclusa® encompasses two HCV therapies (Sofosbuvir/Velpatasvir) in a fixed-dose, orally administered tablet. The therapy first received FDA approval in June 2016 with an indication for all six major genotypes of the virus in patients with chronic HCV, both with and without cirrhosis. The expanded labeling will now also include patients co-infected with HIV.

The expanded FDA approval was based on data from the phase 3 ASTRAL-5 study designed to   evaluate 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. The data showed that 95% of these patients (101/106) reached a sustained virological response by exhibiting undetectable hepatitis viral loads 12 weeks after completing therapy.

“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,” said David Wyles, MD, Chief, Division of Infectious Disease, Denver Health Medical Center; Associate Professor of Medicine, University of Colorado School of Medicine. “With Epclusa, physicians have an important new treatment option for their HCV/HIV co-infected patients.”

The updated label for Epclusa® also includes an FDA-imposed “boxed warning” specific to the risk of hepatitis B viral (HBV) reactivation in patients who had been co-infected with HCV/HBV. The warning advises that all patients with evidence of current or prior HBV infection should be screened prior to initiating treatment with Epclusa®.

The boxed warning coincided with an FDA safety announcement issued in October 2016 about the risk of HBV becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines (including Epclusa®) for HCV. The impetus for the warning were a handful of cases of HBV reactivation in patients treated with DAA drugs, resulting in serious liver problems or death.

The National Hemophilia Foundation’s (NHF) Medical and Scientific Advisory Council has also issued a pair of recommendations relevant to HCV treatment and screening. Access these documents on the NHF website:

MASAC Recommendations on Treatment of Hepatitis C in Individuals with Hemophilia and Other Bleeding Disorders

MASAC Recommendations on Screening for Development of Hepatocellular Cancer in Patients with Hepatitis C

Source: Gilead press release dated August 1, 2017