U.S. Food and Drug Administration Approves Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
Who Approved this:
The US Food and Drug Administration has approved tenofovir alafenamide (Vemlidy, Gilead Sciences) 25 mg once daily, for treatment of adults with chronic hepatitis B virus (HBV) infection with compensated liver disease, the company announced.
Gilead Sciences’ tenofovir disoproxil fumarate (Viread), it has potent antiviral activity in patients with chronic HBV infection, when use this for long time it has renal side effects and cause reduced bone mineral density in some patients.
Vemlidy is a targeted prodrug of tenofovir that has antiviral efficacy similar to that of Viread at a dose less than 1/10th that of Viread, the company notes.
Data Uses for Approval
Vemlidy’s approval was based on 48-week data from two international phase 3 studies (Study 108 and Study 110) among 1298 treatment-naive and treatment-experienced adults with chronic HBV infection.
Study 108 randomly assigned and treated 425 HBeAg-negative patients with either Vemlidy or Viread; Study 110 randomly assigned and treated 873 HBeAg-positive patients with either Vemlidy or Viread.
Results of the studies
In both studies, Vemlidy proved noninferior to Viread, as determined on the basis of the percentage of patients with chronic hepatitis B with plasma HBV DNA levels lower than 29 IU/mL at 48 weeks of therapy.
In an integrated analysis of both studies, patients receiving Vemlidy had improvements in certain bone and renal laboratory parameters compared to patients treated with Viread. Patients taking Vemlidy also had numerically higher rates of normalization of blood serum alanine aminotransferase levels.
Both drugs were generally well tolerated; rates of discontinuation because of adverse events were around 1%. The most commonly noted adverse effects in both studies included headache, abdominal pain, fatigue, cough, nausea, and back pain. The rates of these events were similar for patients taking Vemlidy or Viread.
Vemlidy carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of hepatitis B.