Switching to tenofovir disoproxil fumarate vs continuing treatment in patients with chronic hepatitis B who maintain long-term virological response to entecavir therapy: A randomized trial

Journal of Medical Virology
Ayako Iida-UenoNorifumi Kawada

Abstract

No controlled trial in patients with chronic hepatitis B virus (HBV) infection on long-term entecavir (ETV) treatment, comparing switching to tenofovir disoproxil fumarate (TDF) with continuing the therapy, has been reported. Twenty-seven nucleos(t)ide-naïve patients with chronic HBV who underwent ETV therapy for ≥5 years and maintained virological response were included and randomized into two groups: one group continued ETV, and the other switched to TDF, in a 1:2 ratio. The primary endpoint was changed from baseline in serum hepatitis B surface antigen (HBsAg) level at week 48. The baseline characteristics were not different between nineteen patients in the TDF group and eight patients in the ETV group. Mean decreases in HBsAg level at week 48 were 0.023 and 0.042 log10  IU/mL in the TDF and ETV groups, respectively (P = 0.94). The mean drops in hepatitis B core-related antigens were also not different between the TDF and ETV groups at week 48 (P = 0.80). HBV DNA was sustainedly <2.1 log 10  copies/mL in all patients throughout the study period. In contrast, the mean aminotransferase levels were significantly higher in the TDF group than in the ETV group at weeks 12, 24, and 36, although being within the reference range. Est...Continue Reading

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Citations

Jun 10, 2020·JGH Open : an Open Access Journal of Gastroenterology and Hepatology·Nobuharu TamakiNamiki Izumi
Jan 7, 2021·Liver International : Official Journal of the International Association for the Study of the Liver·Zhong-Bin LiDong Ji
Jan 26, 2021·JGH Open : an Open Access Journal of Gastroenterology and Hepatology·Norio ItokawaKatsuhiko Iwakiri
Jan 21, 2022·European Journal of Gastroenterology & Hepatology·Takashi KumadaJunko Tanaka

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