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NOVEMBER 18, 2016

FDA Approves Gilead’s Vemlidy To Treat Chronic HBV

By IDSE News Staff

The FDA approved tenofovir alafenamide (TAF; Vemlidy, Gilead) 25 mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

TAF will have a boxed warning regarding the risks for lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of HBV.
TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of