FDA approves Vemlidy (tenofovir alafenamide), (TAF), a treatment for chronic hepatitis B virus infection.- Gilead Sciences
Gilead Sciences, Inc. announced that the FDA has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B.
Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF) 300mg. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, Vemlidy improved renal and bone laboratory safety parameters compared to Viread.
Comment:TAF is already approved as part of Gilead's combination HIV treatment Genvoya (emtricitabine/cobicistat/elvitegravir/tenofovir alafenamide).
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