FDA Approves Vemlidy to Treat Chronic Hepatitis B Virus Infection

The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ Vemlidy (tenofovir alafenamide, TAF) 25 mg once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Approval was based upon data from two international Phase III studies (Studies 108 and 110) conducted over a 48-week period among 1,298 treatment-naive and treatment-experienced adult patients with chronic HBV infection. Study 108 treated 425 HBeAg-negative patients with either Vemlidy or Viread (an HIV drug approved to treat HBV in 2008), and Study 110 randomized and treated 837 HBeAg-positive patients with either Vemlidy or Viread. Both studies met their primary endpoint of noninferiority to Viread based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy. But, Vemlidy also demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with Viread. And, patients in the Vemlidy arm experienced numerically higher rates of normalization of blood serum alanine aminotransferase levels.