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

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 litera...

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Autores principales: Huang, Xiaojie, Hou, Jianhua, Song, Aixin, Liu, Xinchao, Yang, Xiaodong, Xu, Junjie, Zhang, Jing, Hu, Qinghai, Chen, Hui, Chen, Yaokai, Meyers, Kathrine, Wu, Hao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6131617/
https://www.ncbi.nlm.nih.gov/pubmed/30233355
http://dx.doi.org/10.3389/fphar.2018.00799
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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
author_facet Huang, Xiaojie
Hou, Jianhua
Song, Aixin
Liu, Xinchao
Yang, Xiaodong
Xu, Junjie
Zhang, Jing
Hu, Qinghai
Chen, Hui
Chen, Yaokai
Meyers, Kathrine
Wu, Hao
author_sort Huang, Xiaojie
collection PubMed
description 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.
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spelling pubmed-61316172018-09-19 Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis Huang, Xiaojie Hou, Jianhua Song, Aixin Liu, Xinchao Yang, Xiaodong Xu, Junjie Zhang, Jing Hu, Qinghai Chen, Hui Chen, Yaokai Meyers, Kathrine Wu, Hao Front Pharmacol Pharmacology 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. Frontiers Media S.A. 2018-09-04 /pmc/articles/PMC6131617/ /pubmed/30233355 http://dx.doi.org/10.3389/fphar.2018.00799 Text en Copyright © 2018 Huang, Hou, Song, Liu, Yang, Xu, Zhang, Hu, Chen, Chen, Meyers and Wu. http://creativecommons.org/licenses/by/4.0/ 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.
spellingShingle Pharmacology
Huang, Xiaojie
Hou, Jianhua
Song, Aixin
Liu, Xinchao
Yang, Xiaodong
Xu, Junjie
Zhang, Jing
Hu, Qinghai
Chen, Hui
Chen, Yaokai
Meyers, Kathrine
Wu, Hao
Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis
title Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis
title_full Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis
title_fullStr Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis
title_full_unstemmed Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis
title_short Efficacy and Safety of Oral TDF-Based Pre-exposure Prophylaxis for Men Who Have Sex With Men: A Systematic Review and Meta-Analysis
title_sort efficacy and safety of oral tdf-based pre-exposure prophylaxis for men who have sex with men: a systematic review and meta-analysis
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6131617/
https://www.ncbi.nlm.nih.gov/pubmed/30233355
http://dx.doi.org/10.3389/fphar.2018.00799
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