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IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Clinical and Experimental Hepatology Pub Date : 2025-03-19 DOI:10.1016/j.jceh.2025.102541

Syed H. Ali , Muhammad H. Shah , Sakshi Roy , Hareesha R. Bharadwaj , Joecelyn K. Tan , Medha S. Rao , Muhtasim Fuad , Arjun Ahluwalia , Aditya Gaur , Priyal Dalal , Arkadeep Dhali , Harishankar Gopakumar

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引用次数: 0

摘要

背景和目标慢性乙型肝炎病毒仍是发展中国家肝病的一个重要病因，可导致肝细胞癌等后遗症。虽然恩替卡韦（ETV）是一线治疗药物，但其耐药率不断上升，凸显了探索可行替代药物的必要性。富马酸替诺福韦二吡呋酯（TDF）单药疗法和恩替卡韦加替诺福韦（TDF + ETV）联合疗法均可作为治疗手段，但二者的疗效存在争议。本荟萃分析旨在研究这两种疗法的优先性。方法我们在PubMed/Medline、Embase、Cochrane Central、Web of Science和中国国家知识基础设施中进行了全面的文献检索，检索时间从开始到2024年10月7日。我们考虑了对恩替卡韦耐药患者进行TDF单药治疗与TDF+ETV联合治疗的安全性和有效性比较的研究。提取了有关病毒学应答（VR）、病毒学突破、HbeAg血清转换、HbeAg/HbsAg血清清除和丙氨酸氨基转移酶正常化的数据。计算出相对风险（RR）及其相应的 95% 置信区间（CI），将其汇总并在随机效应模型中进行分析。结果9项研究符合标准，包括335名接受单一疗法的患者和352名接受联合疗法的患者。研究发现，TDF + ETV联合疗法略优于TDF单药疗法，在48周时可刺激VR（RR 1.081 95% CI：[1.001-1.167] P = 0.046，I2 = 0%）和HbeAg血清转换率（RR 1.711 95% CI：[1.005-2.913] P = 0.048，I2 = 0%）。结论在为期48周的治疗方案中，TDF+ETV的疗效略优于TDF单药治疗，且安全性极低。本综述已在 PROSPERO 数据库注册（ID：CRD42024581443）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Efficacy and Safety of Tenofovir Plus Entecavir Combination Therapy Versus Tenofovir Monotherapy in Chronic Hepatitis B Virus Patients With Resistance or Partial Response to Entecavir: A Systematic Review and Meta-analysis

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Background and objectives

Chronic hepatitis B virus remains a significant cause of liver disease in the developing world, leading to sequelae such as hepatocellular carcinoma. While entecavir (ETV) serves as a first-line treatment, its growing resistance rates underscore the need to explore viable alternatives. Tenofovir disoproxil fumarate (TDF) monotherapy and entecavir plus tenofovir (TDF + ETV) combination therapy are both employed as treatments, but one's efficacy over another is in question. This meta-analysis aims to investigate any primacy of either treatment.

Methods

We conducted a comprehensive literature search across PubMed/Medline, Embase, Cochrane Central, Web of Science, and China National Knowledge Infrastructure from inception till 7th October 2024. Studies comparing the safety and efficacy of TDF monotherapy versus TDF + ETV combination therapy in patients resistant to entecavir were considered. Data about the virologic response (VR), virologic breakthrough, HbeAg seroconversion, HbeAg/HbsAg seroclearance, and alanine aminotransferase normalization were extracted. Relative risks (RRs) and their corresponding 95% confidence intervals (CIs) were calculated, pooled, and analyzed in a random-effects model. P-value <0.05 was regarded as significant for all analyses.

Results

Nine studies, comprising 335 patients undergoing monotherapy and 352 patients undergoing combination therapy, satisfied the criteria. TDF + ETV combination therapy was found slightly advantageous to TDF monotherapy, stimulating a VR at 48 weeks (RR 1.081 95% CI: [1.001–1.167] P = 0.046, I2 = 0%), along with the HbeAg seroconversion rate (RR 1.711 95% CI: [1.005–2.913] P = 0.048, I2 = 0%). There were no significant adverse events in individual studies to warrant a meta-analysis.

Conclusions

TDF + ETV shows slightly better efficacy to TDF monotherapy over a 48-week treatment regimen, with minimal safety concerns. However, further high-quality studies like randomized controlled trials are needed to further solidify conclusions, with this meta-analysis only achieving borderline significances.