3-year Treatment of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate for Chronic HBV Infection in China
Jinlin Hou, Qin Ning, Zhongping Duan, You Chen, Qing Xie, Fusheng Wang, Lunli Zhang, Shanming Wu, Hong Tang, Jun Li, Feng Lin, Yongfeng Yang, Guozhong Gong, John F. Flaherty, Anuj Gaggar, Shuyuan Mo, Cong Cheng, Grégory Camus, Chengwei Chen, Yan Huang, Jidong Jia, Mingxiang Zhang
Abstract
BACKGROUND AND AIMS: Tenofovir alafenamide (TAF) has similar efficacy to tenofovir disoproxil fumarate (TDF) but with improved renal and bone safety in chronic hepatitis B patients studied outside of China. We report 3-year results from two phase 3 studies with TAF in China (Clinicaltrials.gov: NCT02836249 and NCT02836236). METHODS: Chinese hepatitis B e antigen (HBeAg)-positive and -negative chronic hepatitis B patients with viremia and elevated alanine aminotransferase were randomized 2:1 to TAF or TDF treatment groups and treated in a double-blind fashion for 144 weeks (3 years). Efficacy responses were assessed by individual study while safety was assessed by a pooled analysis. RESULTS: =0.014) and less percentage change in bone mineral density vs. TDF at hip (-0.95% vs. -1.93%) and spine (+0.35% vs. -1.40%). CONCLUSIONS: In chronic hepatitis B patients from China, TAF treatment provided efficacy similar to TDF but with better renal and bone safety at 3 years.