Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir

Summary

Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA \<69 IU/mL) effects. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.

Timeline

Start

2023-08-28

Primary completion

2025-02-03

Completion

2025-02-03

Outcome

Met primary endpoint

paper Switching from ETV to TAF was noninferior to continuing ETV in maintaining virologic suppression, with comparable biochemical, serologic, and safety outcomes. PMID 42015653 ↗

Publications

• Shin H, Hur MH, Baek YH, Lee CK, Cho YK, Lee JS, Jeong JY, Jung YJ, Kim JK, Kim MY, Seo YS, Chung WJ, Koh MS, Kim JH, Lee YB, Cho EJ, Lee JH, Yu SJ, Yoon JH, Kim YJ. Efficacy and Safety of Switching from Entecavir to Tenofovir Alafenamide in Chronic Hepatitis B: A Multicenter Randomized Trial in Korea. Gut Liver. 2026 Apr 22. doi: 10.5009/gnl250479. Online ahead of print.

Drugs

Indications