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

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  1 , Jianhua Hou  1 , Aixin Song  1 , Xinchao Liu  2 , Xiaodong Yang  1 , Junjie Xu  3 , Jing Zhang  3 , Qinghai Hu  3 , Hui Chen  4 , Yaokai Chen  5 , Kathrine Meyers  6 , Hao Wu  1
Affiliations

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 et al. Front Pharmacol. .

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.

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Figures

Figure 1
Figure 1
Flow diagram of this systematic review and meta-analysis.
Figure 2
Figure 2
Forest plot for overall analysis of PrEP and HIV incidence (ER).
Figure 3
Figure 3
Forest plot for overall analysis of PrEP and HIV incidence (RR).
Figure 4
Figure 4
Forest plot for overall analysis of PrEP and any AEs (ER).
Figure 5
Figure 5
Forest plot for overall analysis of PrEP and grade 3 or 4 AEs (RR).
See this image and copyright information in PMC

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