20th International AIDS Conference - Melbourne, Australia


THPE196 - Poster Exhibition

Risk assessment and eligibility for pre-exposure prophylaxis to prevent HIV infection among men who have sex with men

I. Zablotska, A. Grulich

The University of New South Wales, The Kirby Institute, Sydney, Australia

Background: Four randomized trials have demonstrated the preventative efficacy of daily oral pre-exposure prophylaxis (PrEP). PrEP effectiveness depends on two interrelated factors: (1) ability to correctly identify individuals and conditions for effective PrEP, and (2) adherence to the medication schedule. While daily oral TDF/FTC (Truvada) is licensed by the US Food and Drug Administration (FDA) as PrEP, including for men who have sex with men (MSM), behavioural eligibility criteria for PrEP are not well defined.
Methods: We reviewed the existent guidelines, peer-reviewed literature and protocols of the ongoing PrEP clinical trials and demonstration projects for their eligibility criteria and behavioural risk-assessment procedures to identify MSM eligible for daily PrEP.
Results: Clinical guidance on PrEP has been issued in the US (2011) and South Africa (2012), but neither covers the behavioural eligibility criteria nor recommends risk assessment tools. Regulatory and normative guidance, specifically US FDA approval of Truvada for PrEP (2012) and WHO (2012), identify eligible populations but not the behavioural eligibility criteria. In the completed clinical trials poor adherence to daily PrEP can be partly explained by suboptimal match of this medication schedule to MSM behavioural patterns. Among 14 ongoing PrEP trials and demonstration projects, an array of behavioural eligibility criteria is used ranging from very broad (e.g., “>1 sex partner for anal intercourse in 12 months”) to more detailed criteria which assess sexual partnerships, practices known to facilitate HIV transmission, and/or indicators of the ongoing risk exposure. Only the New York State clinical guidelines (January 2014) recommend a detailed risk assessment tool, based on the understanding of the local HIV epidemic.
Conclusions: Daily Truvada has a proven potential to reduce chances of HIV infection in MSM, but it is likely to be difficult for PrEP prescribers to identify MSM who can benefit from it. Other successful medications and schedules may become available in the future. Implementation research needs to develop specific behavioural eligibility criteria and risk assessment tools based on the understanding of current HIV epidemics among MSM. PrEP guidelines and HIV prevention programs should include specific recommendations on who is eligible for and can benefit from PrEP.

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