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Front. Pharmacol. | 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

 Xiaojie Huang1,  Jianhua Hou1,  Aixin Song1,  Xinchao Liu2, Xiaodong Yang1, Junjie Xu3, Jiang Zhang3, Qinghai Hu3,  Hui Chen4, Yaokai Chen5, Kathrine Meyers6 and  Hao WU1*
  • 1Beijing Youan Hospital, Capital Medical University, China
  • 2Infectious Diseases Department, Peking Union Medical College Hospital, China
  • 3The First Affiliated Hospital of China Medical University, China
  • 4School of Biomedical Engineering, Capital Medical University, China
  • 5Chongqing Infectious Disease Medical Center, China
  • 6Aaron Diamond AIDS Research Center, 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<0.001and 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, Preexposure prophylaxis, TDF, Men who have sex with men, Meta-analysis

Received: 16 Apr 2018; Accepted: 03 Jul 2018.

Edited by:

Jean-Paul Deslypere, Besins Healthcare, Thailand

Reviewed by:

Kurt Neumann, Independent researcher
Gaurav Deshpande, HealthCore, Inc, United States  

Copyright: © 2018 Huang, Hou, Song, Liu, Yang, Xu, Zhang, Hu, Chen, Chen, Meyers and WU. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dr. Hao WU, Beijing Youan Hospital, Capital Medical University, Beijing, China, whdoc@sina.com