The results of Short-term of Tenofovir alafenamide treatment in patients with chronic hepatitis B virus infection / Монголын Анагаах Ухаан

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 efficacy 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 efficacy endpoint was the proportion of patients with HBV-DNA<29IU/ml at weeks 24 and 48. Other prespecified efficacy endpoints were the proportion of patients with HBsAg seroconversion to antiHBs at weeks 24 and 48. Study protocol approved at Ethical review Committee of “Ach” Medical University in January 2019 (#19/01/06).@*Results@#The primary efficacy endpoint, an HBV-DNA<29IU/ml at weeks 48 and was achieved by 251 (79.9%) of 314 patients receiving TAF, which was non-inferior to the 113(74.8%) of 151 patients receiving TDF who had an HBV-DNA<29IU/ml. After 48 weeks of treatment, patients receiving TAF hed significantly smaller reductions in bone mineral density(BMD) compared with patients receiving TDF. At weeks 48, median changes in eGFR were signifi-cantly smaller in the TAF recipients compared with the TDF recipients.@*Conclusion@#TAF treatment has the same efficacy 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.