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 act...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.展开更多
基金The study was funded by the Fund of National Natural Science Foundation of China(82073620,82473696)the program of Department of Science and Technology of Liaoning Province Project for the High-Quality Scientific and Technological Development of China Medical University(2022JH2/20200074)+1 种基金the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences(2023-PT320-01)the Public Health Talent Grant by Beijing Municipal Health Commission(Global Health Governance-02-12).
文摘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.
