A combination of tenofovir and alafenamide got FDA approval for treatment of hepatitis B viral infection with compensated liver disease.
Adults with chronic hepatitis B infection and compensated liver disease will soon be able to take a better drug, tenofovir-alafenamide, (Vemlidy/Gilead) the US Food and Drug Administration (FDA) ruled today in approving the drug combo.
The drug is a "novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth of tenofovir disoproxil fumarate (Viread/Gilead) which is given at a 300 mg dose.
The announcement was made by Gilead.
The new drug is to be taken as a daily 25 mg pill.
It comes with a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B.
Because of the lower dose, the new drug is less likely to cause renal or bone problems.
The FDA relied on data from two international phase 3 trials. One enrolled treatment-naive adults and the other treatment experienced adults. In the two studies both groups were randomized to Vemlidy or Viread.
There were few adverse events and among those were headache, abdominal pain, fatigue, ought, nausea, and back pain. Those occurred at similar rates regardless of which drug patients took.