Long-term efficacy and safety of switching from entecavir to tenofovir alafenamide
- 1Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan
Abstract
Aim of the study: While entecavir (ETV) is widely used for chronic hepatitis B (CHB) treatment, tenofovir alafenamide (TAF), which efficiently delivers the active compound to hepatocytes while maintaining lower circulating drug levels, has recently been introduced as an alternative treatment option. However, the clinical implications of switching to TAF in patients who have already achieved sustained viral suppression with ETV remain uncertain. Therefore, this study aimed to clarify the long-term efficacy and safety of switching to TAF in patients with CHB who were stable with long-term ETV treatment.
Material and methods: This prospective observational study included nucleoside analogue-naïve patients with genotype C CHB receiving long-term ETV therapy, who either continued ETV therapy (n = 31) or switched to TAF (n = 46). The primary endpoint was the longitudinal change in hepatitis B surface antigen (HBsAg) levels over 384 weeks. Secondary outcomes included changes in biochemical parameters, fibrosis marker dynamics, and renal safety indicators.
Results: After 384 weeks, no significant reduction in HBsAg levels was observed in the ETV and TAF groups (–0.575 ±0.151 and –0.531 ±0.160 log IU/ml, respectively; p = 0.675). Changes in alanine aminotransferase, Mac-2 binding protein glycosylation isomer, HB core-related antigen, and renal function indicators showed comparable trends between the groups. The urinary β2-microglobulin/creatinine ratio increased significantly only among patients who continued ETV.
Conclusions: Among patients with genotype C CHB who achieved virological suppression during prolonged ETV therapy, switching to TAF was associated with antiviral outcomes comparable to those observed with continued ETV administration. However, TAF therapy was associated with a more stable profile of renal tubular injury markers.
Related
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- Bictegravir/emtricitabine/tenofovir alafenamide for HIV: a meta-analysis of efficacy across treatment-naïve and experienced populations and comparative effectiveness versus dolutegravir/lamivudine
- Season-adjusted longitudinal changes in serum 25-hydroxyvitamin D during pegylated interferon add-on to ongoing tenofovir alafenamide therapy in chronic hepatitis B: a real-world cohort study
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BibTeX
@article{hagiwara2026longterm,
title = {{Long-term efficacy and safety of switching from entecavir to tenofovir alafenamide}},
author = {Satoru Hagiwara and Takuya Matsubara and Naoya Omaru and Natsuki Okai and Yoriaki Komeda and Kazuomi Ueshima and Yasunori Minami and Masahiro Takita and Masahiro Morita and Hirokazu Chishina and Naoshi Nishida and Masatoshi Kudo},
journal = {Clinical and Experimental Hepatology},
year = {2026},
month = sep,
doi = {10.5114/ceh.2026.164768},
url = {https://doi.org/10.5114/ceh.2026.164768},
note = {CC BY-NC-SA 4.0},
}
RIS
TY - JOUR
TI - Long-term efficacy and safety of switching from entecavir to tenofovir alafenamide
AU - Satoru Hagiwara
AU - Takuya Matsubara
AU - Naoya Omaru
AU - Natsuki Okai
AU - Yoriaki Komeda
AU - Kazuomi Ueshima
AU - Yasunori Minami
AU - Masahiro Takita
AU - Masahiro Morita
AU - Hirokazu Chishina
AU - Naoshi Nishida
AU - Masatoshi Kudo
PY - 2026
DA - 2026/09/30
JO - Clinical and Experimental Hepatology
DO - 10.5114/ceh.2026.164768
UR - https://doi.org/10.5114/ceh.2026.164768
AB - Aim of the study: While entecavir (ETV) is widely used for chronic hepatitis B (CHB) treatment, tenofovir alafenamide (TAF), which efficiently delivers the active compound to hepatocytes while maintaining lower circulating drug levels, has recently been introduced as an alternative treatment option. However, the clinical implications of switching to TAF in patients who have already achieved sustained viral suppression with ETV remain uncertain. Therefore, this study aimed to clarify the long-term efficacy and safety of switching to TAF in patients with CHB who were stable with long-term ETV treatment. Material and methods: This prospective observational study included nucleoside analogue-naïve patients with genotype C CHB receiving long-term ETV therapy, who either continued ETV therapy (n = 31) or switched to TAF (n = 46). The primary endpoint was the longitudinal change in hepatitis B surface antigen (HBsAg) levels over 384 weeks. Secondary outcomes included changes in biochemical parameters, fibrosis marker dynamics, and renal safety indicators. Results: After 384 weeks, no significant reduction in HBsAg levels was observed in the ETV and TAF groups (–0.575 ±0.151 and –0.531 ±0.160 log IU/ml, respectively; p = 0.675). Changes in alanine aminotransferase, Mac-2 binding protein glycosylation isomer, HB core-related antigen, and renal function indicators showed comparable trends between the groups. The urinary β2-microglobulin/creatinine ratio increased significantly only among patients who continued ETV. Conclusions: Among patients with genotype C CHB who achieved virological suppression during prolonged ETV therapy, switching to TAF was associated with antiviral outcomes comparable to those observed with continued ETV administration. However, TAF therapy was associated with a more stable profile of renal tubular injury markers.
SN - 2392-1099
SN - 2449-8238
ER -