Wu Zhen-Hao, Zhu Yan-Yan, Huang Xiao-Jie, Chen Shuo, Chu Zhen-Xing, Wang Hui, Chen Yao-Kai, Jiang Yong-Jun, Shang Hong, Hu Qing-Hai
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, NHC Key Laboratory of AIDS Prevention and Treatment, National Clinical Research Center for Laboratory Medicine, The First Hospital of China Medical University, China Medical University, Shenyang, 110001, China.
Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, 110001, China.
Infect Dis Poverty. 2025 Apr 27;14(1):31. doi: 10.1186/s40249-025-01305-9.
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 .
背景：口服恩曲他滨替诺福韦酯（F/TDF）用于HIV暴露前预防（PrEP）通过对乙型肝炎病毒（HBV）的抗病毒活性展现出双重潜力。虽然F/TDF对丙型肝炎病毒（HCV）缺乏活性，但使用F/TDF进行HIV PrEP可能通过风险补偿增加HCV感染风险。本研究旨在调查使用基于F/TDF的HIV PrEP的男男性行为者（MSM）中的HBV/HCV感染率，填补低收入和中等收入国家的证据空白。 方法：我们对中国真实世界PrEP口服摄入研究（CROPrEP）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。二次分析仅纳入HBV易感（乙肝表面抗原阴性、乙肝表面和核心抗体阴性）的MSM，以计算HBV感染率。主要结局是12个月随访时的HBV/HCV感染率。贝叶斯泊松回归确定HBV/HCV感染危险因素。 结果：CROPrEP队列在基线时前瞻性招募了1023名F/TDF使用者和507名F/TDF非使用者。这项二次分析纳入了259名在基线时被确定为HBV易感的F/TDF使用者和120名非使用者。在12个月随访时，F/TDF使用者组未发生新发HBV感染，F/TDF非使用者组仅发生1例新发HBV感染。HBV易感的F/TDF使用者中新发HBV感染率为0.00/100人年（PY）[95%置信区间（CI）：0.00 - 1.32]，HBV易感的F/TDF非使用者中为0.77/100 PY（95% CI：0.02 - 4.20）。与未使用F/TDF相比，使用F/TDF可降低HBV感染率[调整感染率比（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感染率分别为0.
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