Efficacy and Safety of Switching from Entecavir to Tenofovir Alafenamide in Chronic Hepatitis B: A Multicenter Randomized Trial in Korea
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background/Aims: Tenofovir alafenamide (TAF) has emerged as a safe and effective alternative to entecavir (ETV) in the management of chronic hepatitis B (CHB). We aimed to evaluate the efficacy and safety of switching to TAF compared with maintaining ETV in patients with CHB who had achieved virologic suppression on ETV. Methods: In this multicenter, randomized, open-label, active-controlled, noninferiority clinical trial conducted at 13 Korean centers, 196 CHB patients who had experienced virologic suppression after ≥24 weeks of ETV therapy were randomized 1:1 to switch to TAF (n=95) or continue on ETV (n=101). The primary endpoint was the proportion of patients with hepatitis B virus (HBV) DNA <29 IU/mL at week 48 (per-protocol set). Secondary endpoints included alanine aminotransferase (ALT) normalization, hepatitis B surface antigen and hepatitis B e antigen serologic responses, and safety outcomes. Results: Among 188 patients in the per-protocol set (89 TAF, 99 ETV), the HBV suppression rate at week 48 was 100.0% in the TAF group and 99.0% in the ETV group (difference, 1.03%; one-sided 97.5% confidence interval, -0.96 to infinity). ALT normalization rates at week 48 were comparable between groups (55.0% in TAF vs 38.7% in ETV; p=0.26; American Association for the Study of Liver Diseases criteria). Hepatitis B e antigen seroconversion rates were also similar at week 48 (0.0% vs 12.5%; p=0.21). Safety profiles, including renal function, did not significantly differ between the two groups. Conclusions: Switching from ETV to TAF was noninferior to continuing ETV in maintaining virologic suppression, with comparable biochemical, serologic, and safety outcomes. (ClinicalTrials. gov identifier NCT06000657).
Source: Gut and Liver
DOI: 10.5009/gnl250479
Authors: Hyunjae Shin, Moon Haeng Hur, Yang Hyun Baek, Chun Kyon Lee, Yong Kyun Cho, June Sung Lee, Jae Yoon Jeong, Yong Jin Jung, Ja Kyung Kim, Moon Young Kim, Yeon Seok Seo, Woo Jin Chung, Moon Soo Koh, Jeong-Han Kim, Yun Bin Lee, Eun Ju Cho, Jeong-Hoon Lee, Su Jong Yu, Jung-Hwan Yoon, Yoon Jun Kim
Institutions: Seoul National University, Dong-A University Hospital, Dong-A University, National Health Insurance Service Ilsan Hospital, Kangbuk Samsung Hospital, Sungkyunkwan University, Inje University Ilsan Paik Hospital, Ewha Womans University, Ewha Womans University Mokdong Hospital, Seoul Metropolitan Government, SNUH SMG-SNU Boramae Medical Center, Yonsei University, Konkuk University, Konkuk University Medical Center, Yongin Severance Hospital, Wonju Severance Christian Hospital, Korea University Anam Hospital, Keimyung University Daegu Dongsan Hospital, Keimyung University Dongsan Hospital, Dongguk University Ilsan Hospital
Language: English
Topic: Hepatitis B Virus Studies
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
Funder: Daewoong Pharmaceutical Company
OpenAlex ID: W7155179786
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