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Meta-Analysis
. 2016 Jul 31;30(12):1973-83.
doi: 10.1097/QAD.0000000000001145.

Effectiveness and safety of oral HIV preexposure prophylaxis for all populations

Virginia A Fonner  1 , Sarah L Dalglish, Caitlin E Kennedy, Rachel Baggaley, Kevin R O'Reilly, Florence M Koechlin, Michelle Rodolph, Ioannis Hodges-Mameletzis, Robert M Grant
Affiliations
Meta-Analysis

Effectiveness and safety of oral HIV preexposure prophylaxis for all populations

Virginia A Fonner et al. AIDS. .

Abstract

Objective: Preexposure prophylaxis (PrEP) offers a promising new approach to HIV prevention. This systematic review and meta-analysis evaluated the evidence for use of oral PrEP containing tenofovir disoproxil fumarate as an additional HIV prevention strategy in populations at substantial risk for HIV based on HIV acquisition, adverse events, drug resistance, sexual behavior, and reproductive health outcomes.

Design: Rigorous systematic review and meta-analysis.

Methods: A comprehensive search strategy reviewed three electronic databases and conference abstracts through April 2015. Pooled effect estimates were calculated using random-effects meta-analysis.

Results: Eighteen studies were included, comprising data from 39 articles and six conference abstracts. Across populations and PrEP regimens, PrEP significantly reduced the risk of HIV acquisition compared with placebo. Trials with PrEP use more than 70% demonstrated the highest PrEP effectiveness (risk ratio = 0.30, 95% confidence interval: 0.21-0.45, P < 0.001) compared with placebo. Trials with low PrEP use did not show a significantly protective effect. Adverse events were similar between PrEP and placebo groups. More cases of drug-resistant HIV infection were found among PrEP users who initiated PrEP while acutely HIV-infected, but incidence of acquiring drug-resistant HIV during PrEP use was low. Studies consistently found no association between PrEP use and changes in sexual risk behavior. PrEP was not associated with increased pregnancy-related adverse events or hormonal contraception effectiveness.

Conclusion: PrEP is protective against HIV infection across populations, presents few significant safety risks, and there is no evidence of behavioral risk compensation. The effective and cost-effective use of PrEP will require development of best practices for fostering uptake and adherence among people at substantial HIV risk.

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Figures

Fig. 1
Fig. 1
Disposition of study citations during searching and screening process.
Fig. 2
Fig. 2
Depicts the fitted meta-regression line of the relationship between trial-level PrEP adherence and PrEP's effectiveness in preventing HIV acquisition.
See this image and copyright information in PMC

References

    1. UNAIDS. The GAP Report. Geneva, Switzerland: UNAIDS; 2014.
    1. World Health Organization. Guidance on preexposure oral prophylaxis (prep) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV. Geneva, Switzerland: WHO; 2012. - PubMed
    1. World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. Geneva, Switzerland: WHO; 2014. - PubMed
    1. World Health Organization. Guideline on when to start antiretroviral therapy and on preexposure prophylaxis for HIV. Geneva, Switzerland: WHO; 2015. - PubMed
    1. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009; 6:e1000097. - PMC - PubMed