Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis

Xiaojie Huang; Jianhua Hou; Aixin Song; Xinchao Liu; Xiaodong Yang; Junjie Xu; Jing Zhang; Qinghai Hu; Hui Chen; Yaokai Chen; Kathrine Meyers; Hao Wu

doi:10.3389/fphar.2018.00799

Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis

Front Pharmacol. 2018 Sep 4:9:799. doi: 10.3389/fphar.2018.00799. eCollection 2018.

Authors

Xiaojie Huang¹, Jianhua Hou¹, Aixin Song¹, Xinchao Liu², Xiaodong Yang¹, Junjie Xu³, Jing Zhang³, Qinghai Hu³, Hui Chen⁴, Yaokai Chen⁵, Kathrine Meyers⁶, Hao Wu¹

Affiliations

¹ Center for Infectious Diseases, Beijing You'an Hospital, Capital Medical University, Beijing, China.
² Infectious Diseases Department, Peking Union Medical College Hospital, Beijing, China.
³ Key Laboratory of AIDS Immunology of National Health and Family Planning Commission, Department of Laboratory Medicine, The First Affiliated Hospital, China Medical University, Shenyang, China.
⁴ School of Biomedical Engineering, Capital Medical University, Beijing, China.
⁵ Department of Infectious Diseases, Chonging Public Health Medical Center, Chongqing, China.
⁶ The Aaron Diamond AIDS Research Center, New York, NY, United States.

Abstract

Background: Pre-exposure prophylaxis (PrEP) is used as an HIV prevention method by people at substantial risk of HIV infection. This systematic review and meta-analysis evaluates current clinical evidence for use of oral TDF-based PrEP among men who have sex with men. Methods: A comprehensive literature search in PubMed, web of science, Google Scholar and ClinicalTrials.gov was performed. A random-effects meta-analysis was conducted using the event rate (ER) for estimation of the incidence of HIV and grade 3 or 4 adverse events (AE) among PrEP arm and using risk ratio (RR) for comparison of incidence of HIV and grade 3 or 4 AE between PrEP recipients and PrEP non-users. Blood-based adherence levels were also divided into three categories with reference to previous meta-analysis. Subgroup meta-analysis was also performed to evaluate whether blood-based adherence levels moderated the effect of TDF-based PrEP on HIV incidence. Narrative review was used due to inconsistent measurements of risk behavior and drug resistance. This review is registered on the PROSPERO database (CRD42017077965). Results: Fourteen studies were included in the review. Oral TDF-based PrEP significantly reduced HIV incidence with minimum drug resistance and tolerable safety risks (HIV incidence, ER = 1.1%, 95% CI 0.6-2.0%, p < 0.001, RR = 0.244, 95% CI 0.111-0.537, p < 0.001 and grade 3 or 4 AEs, ER = 13.0%, 95% CI 9.9-16.9%, p < 0.001, RR = 1.059, 95% CI 0.824-1.362, p = 0.653). Oral TDF-based PrEP was more effective in reducing HIV incidence with high levels of blood-based PrEP adherence (ER, 0.4%) compared to moderate adherence (2.9%; p < 0.001). Most studies found no association between PrEP use and self-reported sexual behavior. Conclusion: Oral TDF-based PrEP is an effective intervention to prevent against HIV infection among MSM. Well-designed implementation science studies that integrate sociobehavioral and biomedical interventions are needed to identify optimal PrEP delivery models in different populations to translate biomedical efficacy into real-world efficacy.

Keywords: HIV; TDF; men who have sex with men; meta-analysis; pre-exposure prophylaxis.