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Review
. 2017 Apr;40(4):273-283.
doi: 10.1007/s40264-017-0505-6.

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns

Raymond A Tetteh  1   2 , Barbara A Yankey  3 , Edmund T Nartey  4   5 , Margaret Lartey  6 , Hubert G M Leufkens  7   8 , Alexander N O Dodoo  4
Affiliations
Review

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns

Raymond A Tetteh et al. Drug Saf. 2017 Apr.

Abstract

Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www.clinicaltrials.gov " and scholar.google, using combination search terms 'pre-exposure prophylaxis', 'safety concerns in the use of pre-exposure prophylaxis', 'truvada use as PrEP', 'guidelines for PrEP use', 'HIV pre-exposure prophylaxis' and 'tenofovir' to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits observed in clinical trials are maintained in real-world use.

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Conflict of interest statement

Funding

No sources of funding were used to assist in the preparation of this review.

Conflict of interest

Raymond A. Tetteh, Barbara A. Yankey, Edmund T. Nartey, Margaret Lartey, Hubert G.M. Leufkens, and Alexander N.O. Dodoo have no conflicts of interest that are directly relevant to the content of this review.

Ethics approval

Ethical approval for the study was not obtained as it was a review of published work.

Figures

Fig. 1
Fig. 1
Chart of search strategy for clinical trials on pre-exposure prophylaxis based on tenofovir (TDF), emtricitabine (FTC) and a TDF/FTC combination. AVAC Aids Vaccine Advocacy Coalition
See this image and copyright information in PMC

References

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    1. Weinhardt LS, Carey MP, Johnson BT, Bickham NL. Effects of HIV counseling and testing on sexual risk behavior: a meta-analytic review of published research, 1985–1997. Am J Public Health. 1999;89(9):1397–1405. doi: 10.2105/AJPH.89.9.1397. - DOI - PMC - PubMed
    1. Castilla J, Del Romero J, Hernando V, et al. Effectiveness of highly active antiretroviral therapy in reducing heterosexual transmission of HIV. J Acquir Immune Defic Syndr. 2005;40(1):96–101. doi: 10.1097/01.qai.0000157389.78374.45. - DOI - PubMed
    1. Kirby T, Thornber-Dunwell M. Uptake of PrEP for HIV slow among MSM. Lancet. 2014;383(9915):399–400. doi: 10.1016/S0140-6736(14)60137-9. - DOI - PubMed
    1. Molina JM, Capitant C, Spire B, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med. 2015;373(23):2237–2246. doi: 10.1056/NEJMoa1506273. - DOI - PubMed

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