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

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 .

Keywords: Bayesian Poisson regression; Hepatitis B virus; Hepatitis C virus; Incidence; Men who have sex with men; Pre-exposure prophylaxis.

Fig. 1

Study Profile. HBV-susceptible: HBsAg−, anti-HBc−, anti-HBs−. HBV hepatitis B virus, HCV hepatitis C virus, F/TDF emtricitabine-tenofovir disoproxil fumarate, HBsAg hepatitis B surface antigen, Anti-HBc antibody to hepatitis B core antigen, Anti-HBs antibody to hepatitis B surface antigen, Anti-HCV HCV antibody

Fig. 2

Incidence of HBV and HCV Infection. A HBV and HCV incidence rate in F/TDF users and F/TDF non-users. B Incidence rate ratio comparing HBV and HCV incidence in F/TDF users and F/TDF non-users. In Panel A, the I bars indicate 95% confidence intervals. F/TDF emtricitabine-tenofovir disoproxil fumarate, HBsAg hepatitis B surface antigen, Anti-HBc antibody to hepatitis B core antigen, Anti-HBs antibody to hepatitis B surface antigen, CI confidence interval, HBV hepatitis B virus, HCV hepatitis C virus