European regulators have accepted an application from Gilead seeking permission to market tenofovir alafenamide as a single agent treatment for adults with chronic hepatitis B virus (HBV) infection.
Tenofovir alafenamide (TAF) is a novel, targeted prodrug of tenofovir with high antiviral efficacy similar to Gilead’s Viread (tenofovir disoproxil fumarate; TDF) at one-tenth of the dose. Because TAF enters cells more efficiently than TDF it can be given at a lower dose, massively reducing the amount of tenofovir present in the bloodstream.
According to Gilead, TAF also demonstrated in clinical trials improvements in surrogate laboratory markers of renal and bone safety compared to TDF, with patients experiencing a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48, highlighting further potential advantages.
More than 14 million people in Europe currently live with chronic hepatitis B infection and more than 1 million Europeans are newly infected with the virus each year.