Tenofovir alafenamide (TAF) approved in US to treat hepatitis B with EU set to follow
29 November 2016. Related: Hepatitis coinfection.
Simon Collins, HIV i-Base
On 10 November 2016, tenofovir alafenamide (TAF) was approved by the US FDA for the treatment of chronic hepatitis B (HBV) infection in adults and adolescents (>12 years and >35 kgs body weight). [1]
Approval was based on similar efficacy to tenofovir-DF (245 mg) but with improved safety based on kidney and bone markers.
However, for HIV positive patients, TAF needs to be used in combination with other HBV drugs.
The recommended dosage is 25 mg (one tablet) taken orally once daily with food
No dosage adjustment of TAF is required in patients with mild, moderate, or severe renal impairment. TAF is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute)
For full details please refer to the full prescribing information.
Also, on 11th November the scientific committee for the European Medicines Agency gave a positive opinion recommending approval in the European Union. [2] The EU press statement notes that “TAF as a single-agent for HBV is an investigational product and its safety and efficacy have not yet been established.” [2]
TAF is manufactured by Gilead Sciences and has the brand name Vemlidy for the HBV indication.
References:
- Gilead press statement. U.S. Food and Drug Administration approves Gilead’s Vemlidy for the treatment of chronic hepatitis B virus infection.
http://www.gilead.com/news/press-releases/2016/11/us-food-and-drug-administration-approves-gileads-vemlidy-tenofovir-alafenamide-for-the-treatment-of-chronic-hepatitis-b-virus-infection - Gilead press statement. European CHMP adopts positive opinion for Gilead’s Vemlidy for the treatment of chronic hepatitis B virus infection. (11 November 2016).
http://www.gilead.com/news/press-releases/2016/11/european-chmp-adopts-positive-opinion-for-gileads-vemlidy-tenofovir-alafenamide-taf-for-the-treatment-of-chronic-hepatitis-b-virus-infection