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Abstract #3429 - Plenary
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Session: 4.5: Plenary (Plenary) on Wednesday @ 09.00-11.00 in C103 Chaired by Kai Jonas, Lucie Cluver, Catherine Hankins
Authors: Presenting Author: Prof Sheena McCormack - MRC Clinical Trials Unit , United Kingdom
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Aim: Europe was well aware of the ongoing epidemic in gay and other men who have sex
with men (MSM) when iPrEX reported a 44% reduction in HIV incidence in MSM and
transgender women (Grant et al, NEJM, 2010). In fact, the data gathered over the
preceding decade suggested that new infections might be increasing in MSM, in
spite of widespread access to treatment and good control of viral load in those on
antiretroviral therapy. However, we were cautious about launching PrEP
programmes (McCormack et al, Int J STI&AIDS 2012). There were a number of
concerns, not least of all the cost of drug and that MSM taking PrEP would abandon
other risk reduction strategies which would increase their risk of being exposed to
HIV and potentially undermine effectiveness. Although sub-group analysis in iPrEX
and other PrEP trials suggested that biological efficacy could be very high, the
population benefit was modest as a large proportion of trial participants did not take
the trial drug.
Two European trials were launched in 2012 (iPerGay and PROUD) and the results
provide two clear messages: HIV incidence was higher than expected in MSM who
came forward to access PrEP, and they were willing to take Truvada to reduce their
risk of HIV so the population benefit was substantial (86% reduction in HIV incidence
in both trials). The effectiveness of PrEP exceeded the expectation of the
researchers, and was the largest benefit reported in intent to treat analyses (CROI 2015). iPerGay demonstrated that Truvada was highly effective when MSM were
advised to take PrEP before and after sex. The control group was given placebo as it
was necessary to control for behaviour in this design. In contrast, PROUD was an
open-label study comparing PrEP to no-PrEP in order to assess the effectiveness
when MSM knew they were taking a drug that reduced their risk of HIV ie taking
account of any behaviour change. Those on PrEP continued to report condom use
amongst their risk reduction strategies, and there was no difference in other sexually
transmitted infections between the groups.
There is no doubt of the potential that PrEP has to reverse the epidemic. To realise
the full benefit, PrEP will need to be provided during periods of risk, and be
embedded in a comprehensive risk reduction package that includes support for
behaviour change. This will require effective partnerships between community
organisations working with at risk populations, clinicians providing sexual health and
HIV services, epidemiologists and public health policy makers. PROUD and iPerGay
have sparked interest, but in many European countries the partnerships necessary to
deliver PrEP will be new, and demonstration projects will help to build these
successfully, ensuring that we do reverse the current epidemic trend.
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