Switching to Besifovir in Patients with Chronic Hepatitis B Receiving Tenofovir Disoproxil Fumarate: A Randomized Trial.

IF 14 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical and Molecular Hepatology Pub Date : 2025-01-17 DOI:10.3350/cmh.2024.0819

Hyung Joon Yim, Yeon Seok Seo, Ji Hoon Kim, Won Kim, Young Kul Jung, Jae Young Jang, Sae Hwan Lee, Yun Soo Kim, Chang Wook Kim, Hyoung Su Kim, Jae-Jun Shim, Eun-Young Cho, In Hee Kim, Byung Seok Lee, Jeong-Hoon Lee, Byung Seok Kim, Jeong Won Jang, Hyun Woong Lee, Jung Hyun Kwon, Moon Young Kim, Do Seon Song, Jung Gil Park, Yoon Seok Lee, Eileen L Yoon, Han Ah Lee, Seong Hee Kang, Jin Mo Yang

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引用次数: 0

Abstract

Background/aims: Besifovir (BSV) showed comparable antiviral activity superior safety profiles to tenofovir disoproxil fumarate (TDF) in treatment-naïve chronic hepatitis B (CHB). However, no data are available regarding the antiviral efficacy and safety of BSV in patients with CHB who switched from long-term TDF to BSV. This study aimed to evaluate the outcome of a 48-week BSV therapy in patients with CHB who switched from long-term TDF treatment.

Methods: In this non-inferiority trial, 153 CHB patients treated with TDF for ≥48 weeks who had hepatitis B virus (HBV) DNA <20 IU/mL were randomized to receive either BSV 150 mg or TDF 300 mg for 48 weeks.

Results: The per-protocol analysis included 130 patients (BSV group, 64; TDF group, 66). The median duration of TDF use before enrollment was 4.14 years. After 48 weeks, 100.0% and 98.5% patients in the BSV and TDF groups, respectively, met the primary endpoint (HBV DNA <20 IU/mL), demonstrating the non-inferior antiviral efficacy of BSV to TDF (95% CI -0.01 to 0.04; P=1.000), with a predefined margin of -0.18. The mean percentage changes in estimated glomerular filtration rates were slightly better in the BSV group (1.67±11.73%) than in the TDF group (-1.24±11.02%). The BSV group showed a significant improvement in bone turnover biomarkers compared to the TDF group; accordingly, hip and spine bone mineral density increased in the BSV group.

Conclusions: In patients with CHB receiving long-term TDF, switching to BSV may improve renal and bone safety with non-inferior antiviral efficacy compared to that of maintaining TDF. ClinicalTrials.gov Identifier: NCT04202536.

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接受富马酸替诺福韦二氧吡酯治疗的慢性乙型肝炎患者改用贝西福韦：一项随机试验

背景/目的：贝西福韦（BSV）在treatment-naïve慢性乙型肝炎（CHB）中显示出与富马酸替诺福韦二氧吡酯（TDF）相当的抗病毒活性和更高的安全性。然而，对于从长期TDF转为BSV的CHB患者，没有关于BSV抗病毒疗效和安全性的数据。本研究旨在评估从长期TDF治疗转为慢性乙型肝炎患者48周BSV治疗的结果。方法：在这项非劣效性试验中，153例接受TDF治疗≥48周的乙型肝炎病毒（HBV） DNA的CHB患者。结果：按方案分析包括130例患者(BSV组，64例；TDF组，66)。入组前使用TDF的中位持续时间为4.14年。48周后，BSV组和TDF组分别有100.0%和98.5%的患者达到了主要终点（HBV DNA）。结论：与维持TDF相比，长期接受TDF治疗的CHB患者，改用BSV治疗可改善肾脏和骨骼安全性，且抗病毒疗效不差。ClinicalTrials.gov标识符：NCT04202536。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Molecular Hepatology Medicine-Hepatology

CiteScore

15.60

自引率

9.00%

发文量

审稿时长

10 weeks

期刊介绍： Clinical and Molecular Hepatology is an internationally recognized, peer-reviewed, open-access journal published quarterly in English. Its mission is to disseminate cutting-edge knowledge, trends, and insights into hepatobiliary diseases, fostering an inclusive academic platform for robust debate and discussion among clinical practitioners, translational researchers, and basic scientists. With a multidisciplinary approach, the journal strives to enhance public health, particularly in the resource-limited Asia-Pacific region, which faces significant challenges such as high prevalence of B viral infection and hepatocellular carcinoma. Furthermore, Clinical and Molecular Hepatology prioritizes epidemiological studies of hepatobiliary diseases across diverse regions including East Asia, North Asia, Southeast Asia, Central Asia, South Asia, Southwest Asia, Pacific, Africa, Central Europe, Eastern Europe, Central America, and South America. The journal publishes a wide range of content, including original research papers, meta-analyses, letters to the editor, case reports, reviews, guidelines, editorials, and liver images and pathology, encompassing all facets of hepatology.