Safety of tenofovir alafenamide (TAF)

Abstract

Introduction: Worldwide, an estimated two billion people have evidence of HBV infection, and approximately 240 million have CHB. In this study, a representative group of Mongolian adults was tested for hepatitis B virus (HBV) in 2017. The latest data shows that 11.1% of Mongolian adult population are infected with HBV. Goal: Evaluate the efÏcacy and safety of tenofovir alafenamide treatment in patients with chronic hepatitis B. Materials and Methods: The clinical trials have evaluated TAF in HBeAg-positive and HBeAg-negative chronic HBV patients. The trials have similar design and randomized, single blind, non-inferiority studies. The primary efÏcacy endpoint was the proportion of patients with HBV-DNA<29IU/ml at weeks 48 and 96. Other prespecified efÏcacy endpoints were the proportion of patients with HBsAg seroconversion to antiHBs at weeks 48 and 96. Results: The primary efÏcacy endpoint, an HBV-DNA<29IU/ml at weeks 96 and was achieved by 294 (95.7%) of 307 patients receiving TAF, which was non-inferior to the 136(92.5%) of 147 patients receiving TDF who had an HBVDNA<29IU/ml. After 96 weeks of treatment, patients receiving TAF had significantly smaller reductions in bone mineral density (BMD) compared with patients receiving TDF. At weeks 96, median changes in eGFR were significantly smaller in the TAF recipients compared with the TDF recipients. Conclusion: TAF treatment has the same efÏcacy as TDF treatment. However, TAF treatment demonstrates more safety profile compared with TDF treatment. Patients receiving TAF had a significantly smaller median decrease in eGFR, by Cockcroft-Gault equation, than patients receiving TDF.