Alimentary pharmacology & therapeutics · 2026
Superior Efficacy of Tenofovir Alafenamide Compared With Entecavir in Reducing Hepatitis B Surface Antigen: A Multicentre Propensity Score-Matched Study Using Linear Mixed-Effects Models.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Kumada Takashi, Atsukawa Masanori, Itokawa Norio, Arai Taeang, Toyoda Hidenori, Tsubota Akihito, Watanabe Tsunamasa, Chuma Makoto, Matsuura Kentaro, Hiraoka Atsushi, Tada Toshifumi, Takaguchi Koichi, Kato Keizo, Abe Hiroshi, Tani Joji, Ishikawa Toru, Ogawa Chikara, Asano Toru, Oikawa Tsunekazu, Matsumoto Yoshihiro, Akita Tomoyuki, Tanaka Junko
Аннотация
BACKGROUND AND AIMS: Entecavir and tenofovir alafenamide fumarate are potent nucleos(t)ide analogues used to treat chronic hepatitis B; however, their differential effects on hepatitis B surface antigen expression decline remain unclear. In this multicentre study, we aimed to examine the hepatitis B surface antigen-reducing effects.
METHODS: Treatment-naïve chronic hepatitis B patients who received entecavir (n = 491) or tenofovir alafenamide fumarate (n = 463) were enrolled. After 1:1 propensity score matching for sex, baseline hepatitis B surface antigen, hepatitis B e-antigen status, hepatitis B virus deoxyribonucleic acid, fibrosis-4 score, and the presence of hepatocellular carcinoma, data from 334 patients per group were analysed. Linear mixed-effects models were used to assess longitudinal changes over 4 years.
RESULTS: Tenofovir alafenamide fumarate was associated with a greater decline in hepatitis B surface antigen compared to entecavir, with significant differences at 1, 3, and 4 years. Its superiority was most pronounced in patients aged < 65 years, those without cirrhosis, those with baseline hepatitis B surface antigen ≥ 3.0 log IU/mL, those with either negative or positive hepatitis B e-antigen, and those with baseline hepatitis B virus deoxyribonucleic acid < 4.4 log IU/mL. Both treatments achieved comparable virological suppression and alanine aminotransferase normalisation. The estimated glomerular filtration rate showed a transient decline with tenofovir alafenamide fumarate in year 1, which subsequently diminished and may partly reflect the inhibition of tubular creatinine secretion.
CONCLUSIONS: This evidence supports personalised treatment selection for functional cure.
TRIAL REGISTRATION: The UMIN Clinical Trials Registry 000034362.
METHODS: Treatment-naïve chronic hepatitis B patients who received entecavir (n = 491) or tenofovir alafenamide fumarate (n = 463) were enrolled. After 1:1 propensity score matching for sex, baseline hepatitis B surface antigen, hepatitis B e-antigen status, hepatitis B virus deoxyribonucleic acid, fibrosis-4 score, and the presence of hepatocellular carcinoma, data from 334 patients per group were analysed. Linear mixed-effects models were used to assess longitudinal changes over 4 years.
RESULTS: Tenofovir alafenamide fumarate was associated with a greater decline in hepatitis B surface antigen compared to entecavir, with significant differences at 1, 3, and 4 years. Its superiority was most pronounced in patients aged < 65 years, those without cirrhosis, those with baseline hepatitis B surface antigen ≥ 3.0 log IU/mL, those with either negative or positive hepatitis B e-antigen, and those with baseline hepatitis B virus deoxyribonucleic acid < 4.4 log IU/mL. Both treatments achieved comparable virological suppression and alanine aminotransferase normalisation. The estimated glomerular filtration rate showed a transient decline with tenofovir alafenamide fumarate in year 1, which subsequently diminished and may partly reflect the inhibition of tubular creatinine secretion.
CONCLUSIONS: This evidence supports personalised treatment selection for functional cure.
TRIAL REGISTRATION: The UMIN Clinical Trials Registry 000034362.