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

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

JOURNAL=Frontiers in Pharmacology

VOLUME=9

YEAR=2018

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2018.00799

DOI=10.3389/fphar.2018.00799

ISSN=1663-9812

ABSTRACT=<p><bold>Background:</bold> 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.</p><p><bold>Methods:</bold> 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).</p><p><bold>Results:</bold> 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%, <italic>p</italic> &lt; 0.001, RR = 0.244, 95% CI 0.111–0.537, <italic>p</italic> &lt; 0.001 and grade 3 or 4 AEs, ER = 13.0%, 95% CI 9.9–16.9%, <italic>p</italic> &lt; 0.001, RR = 1.059, 95% CI 0.824–1.362, <italic>p</italic> = 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%; <italic>p</italic> &lt; 0.001). Most studies found no association between PrEP use and self-reported sexual behavior.</p><p><bold>Conclusion:</bold> 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.</p>