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
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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