The role of tenofovir-based HIV pre-exposure prophylaxis in preventing HBV infection among men who have sex with men: insights from China.

IF 8.1 1区医学

Infectious Diseases of Poverty Pub Date : 2025-04-27 DOI:10.1186/s40249-025-01305-9

Zhen-Hao Wu, Yan-Yan Zhu, Xiao-Jie Huang, Shuo Chen, Zhen-Xing Chu, Hui Wang, Yao-Kai Chen, Yong-Jun Jiang, Hong Shang, Qing-Hai Hu

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引用次数: 0

Abstract

Background: Oral emtricitabine-tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP) demonstrates dual potential through antiviral activity against hepatitis B virus (HBV). While F/TDF lacks activity against hepatitis C virus (HCV), the use of F/TDF for HIV PrEP may elevate HCV risk through risk compensation. This study aims to investigate HBV/HCV incidence among men who have sex with men (MSM) using F/TDF-based HIV PrEP, addressing evidence gaps in low- and middle-income countries.

Methods: We conducted a secondary analysis of the China Real-World Oral Intake of PrEP (CROPrEP) study, a multicenter prospective cohort of MSM (F/TDF users/non-users) from Beijing, Shenyang, Shenzhen, and Chongqing. Participants underwent HBV/HCV testing at baseline and at the 12-month follow-up. Only HBV-susceptible (hepatitis B surface antigen-negative, hepatitis B surface and core antibody-negative) MSM were included in the secondary analysis, to calculate HBV incidence. The primary outcomes were HBV/HCV incidence rates at the 12-month follow-up. Bayesian Poisson regression identified HBV/HCV infection risk factors.

Results: The CROPrEP cohort prospectively recruited 1023 F/TDF users and 507 F/TDF non-users at baseline. This secondary analysis included 259 F/TDF users and 120 non-users identified as HBV-susceptible at baseline. At the 12-month of follow-up, no incident HBV infections occurred in the F/TDF users group, and only one incident HBV infection occurred in the F/TDF non-users group. The incidence of new HBV infections was 0.00/100 person-years (PY) [95% confidence interval (CI): 0.00-1.32] among HBV-susceptible F/TDF users and 0.77/100 PY (95% CI: 0.02-4.20) among HBV-susceptible F/TDF non-users. HBV incidence was reduced with F/TDF compared with no F/TDF [adjusted incidence rate ratio (aIRR): 0.00; 95% CI: 0.00-0.00]. HCV incidence among F/TDF users and non-users was 0.31/100 PY (95% CI: 0.06-0.90) and 0.00/100 PY (95% CI: 0.00-0.74) after 12 months, respectively. HCV incidence was lower in F/TDF non-users than in F/TDF users (aIRR: 0.00; 95% CI: 0.00-0.25).

Conclusions: This study suggests a potential benefit in reducing HBV incidence among MSM using F/TDF as HIV PrEP, highlighting the potential for integrated prevention strategies addressing both HIV and HBV risks in PrEP programmes.

Trial registration: ChiCTR, ChiCTR-IIN-17013762. Registered 8 December 2017, https://www.chictr.org.cn/showproj.html?proj=22916 .

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以替诺福韦为基础的HIV暴露前预防在男男性行为者中预防HBV感染的作用：来自中国的见解

背景：口服恩曲他滨-替诺福韦二氧吡酯富马酸酯（F/TDF）用于HIV暴露前预防（PrEP）显示出对乙型肝炎病毒（HBV）的双重抗病毒活性。虽然F/TDF缺乏抗丙型肝炎病毒（HCV）的活性，但在HIV PrEP中使用F/TDF可能通过风险补偿提高HCV风险。本研究旨在调查使用基于F/ tdf的HIV PrEP的男男性行为者（MSM）中HBV/HCV的发病率，解决低收入和中等收入国家的证据差距。方法：我们对中国真实世界口服PrEP （CROPrEP）研究进行了二次分析，这是一项来自北京、沈阳、深圳和重庆的MSM （F/TDF使用者/非使用者）的多中心前瞻性队列研究。参与者在基线和12个月随访时接受HBV/HCV检测。仅将HBV易感（乙型肝炎表面抗原阴性、乙型肝炎表面和核心抗体阴性）的男男性行为者纳入二次分析，计算HBV发病率。主要结局是12个月随访期间的HBV/HCV发病率。贝叶斯泊松回归确定HBV/HCV感染的危险因素。结果：CROPrEP队列在基线时前瞻性地招募了1023名F/TDF使用者和507名F/TDF非使用者。这项二次分析包括259名F/TDF使用者和120名基线时确定为hbv易感的非使用者。在12个月的随访中，F/TDF使用者组未发生HBV感染事件，而F/TDF非使用者组仅发生1例HBV感染事件。在HBV易感的F/TDF使用者中，新发HBV感染的发生率为0.00/100人年（PY）[95%可信区间（CI）： 0.00-1.32]，在HBV易感的F/TDF非使用者中，新发HBV感染的发生率为0.77/100人年（PY）（95% CI: 0.02-4.20）。与不加F/TDF组相比，加F/TDF组HBV发病率降低[校正发病率比（aIRR）： 0.00；95% ci: 0.00-0.00]。12个月后，F/TDF使用者和非使用者的HCV发病率分别为0.31/100 PY （95% CI: 0.06-0.90）和0.00/100 PY （95% CI: 0.00-0.74）。非F/TDF服用者的HCV发病率低于F/TDF服用者(aIRR: 0.00；95% ci: 0.00-0.25)。结论：本研究表明，使用F/TDF作为HIV PrEP降低MSM中HBV发病率的潜在益处，强调了在PrEP规划中解决HIV和HBV风险的综合预防策略的潜力。试验注册号：ChiCTR， ChiCTR- iin -17013762。2017年12月8日注册，https://www.chictr.org.cn/showproj.html?proj=22916。

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来源期刊

Infectious Diseases of Poverty INFECTIOUS DISEASES-

自引率

1.20%

发文量

368

期刊介绍： Infectious Diseases of Poverty is an open access, peer-reviewed journal that focuses on addressing essential public health questions related to infectious diseases of poverty. The journal covers a wide range of topics including the biology of pathogens and vectors, diagnosis and detection, treatment and case management, epidemiology and modeling, zoonotic hosts and animal reservoirs, control strategies and implementation, new technologies and application. It also considers the transdisciplinary or multisectoral effects on health systems, ecohealth, environmental management, and innovative technology. The journal aims to identify and assess research and information gaps that hinder progress towards new interventions for public health problems in the developing world. Additionally, it provides a platform for discussing these issues to advance research and evidence building for improved public health interventions in poor settings.