Gilead’s Epclusa gets expanded indication

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Gilead’s Epclusa gets expanded indication

By David Salazar - 08/04/2017

SILVER SPRING, Md. — Gilead Sciences’s Epclusa single-tablet hepatitis C treatment this week got approval from the Food and Drug Administration for an expanded indication. The drug is now approved for use in patients with hepatitis C that are co-infected with HIV.

“HCV co-infection remains a major cause of morbidity in HIV-infected individuals,” said Dr. David Wyles, Denver Health Medical Center’s infectious disease division president said. “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. … With Epclusa, physicians have an important new treatment option for their HCV/HIV co-infected patients.”

Epclusa carries a boxed warning about the risk of hepatitis B virus reactivation in co-infected patients. The FDA approved the drug in 2016 to treat adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin.