The European Commission has approved once-daily tenofovir alafenamide (TAF) 25 mg (Vemlidy, Gilead Sciences) for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents aged 12 years and older weighing at least 35 kg.
The action follows a positive opinion in November 2016 by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Gilead Sciences' tenofovir disoproxil fumarate (TDF) (Viread) has potent antiviral activity in patients with chronic HBV infection, but long-term use has been associated with renal side effects and 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 one tenth that of Viread, the company explained in a news release.
Because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes in comparison with TDF, it can be given at a lower dose, which means there is less tenofovir in the bloodstream. "By reducing exposure to tenofovir, TAF is associated with improved renal and bone laboratory safety parameters compared to TDF in clinical trials," the company said.
"As the first new treatment for chronic hepatitis B to be approved in Europe in nearly a decade, this approval marks a step forward in the management of a progressive, life-threatening disease affecting 13 million Europeans," Pietro Lampertico, MD, PhD, head of gastroenterology and hepatology at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Italy, said in the release.
"Treating a lifelong disease such as chronic hepatitis B can present challenges as patients age, and the improvements in bone and renal laboratory safety parameters demonstrated by TAF compared to TDF allows it to provide an important new option for patients," he noted.
The approval of Vemlidy in Europe was based on 48-week data from two international phase 3 studies (Study 108 and Study 110) that included 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.
In both studies, Vemlidy proved noninferior to Viread, as determined on the basis of the percentage of patients with chronic HBV infection whose plasma HBV DNA levels were lower than 29 IU/mL at 48 weeks of therapy.
In an integrated analysis of both studies, patients receiving Vemlidy experienced improvements in certain bone and renal laboratory parameters compared to patients treated with Viread. In addition, for patients taking Vemlidy, rates of normalization of blood serum alanine aminotransferase levels were numerically higher.
Both drugs were generally well tolerated; rates of discontinuation because of adverse events were around 1%. The most common adverse events 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.
The US Food and Drug Administration approved Vemlidy in November 2016 for treatment of adults with chronic HBV infection with compensated liver disease, as reported by Medscape Medical News.
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Cite this: Europe Clears Tenofovir Alafenamide (Vemlidy) for Chronic HBV - Medscape - Jan 13, 2017.