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High STI Rate in IPERGAY PrEP Study,
But Concentrated in Subgroup
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AIDS 2020: 23rd International AIDS Conference Virtual, July 6-10, 2020
Mark Mascolini
New diagnoses (incidence) of bacterial sexually transmitted infections (STIs) proved high among men who have sex with men (MSM) enrolled in the IPERGAY PrEP trial [1]. Incidence jumped dramatically when the trial's double-blind phase ended, and 39% of participants accounted for 86% of all STIs.
The French IPERGAY trial established that Truvada PrEP taken before and after sex ("on-demand PrEP") protects MSM from HIV infection significantly better than placebo [2,3]. This analysis aimed to determine STI incidence during the study and to pinpoint behavioral risk factors for STIs during follow-up.
IPERGAY enrolled 429 French and Canadian MSM into a randomized, placebo-controlled trial that began in February 2012. An open-label extension phase ran from November 2014 to June 2016. Median follow-up stood at 23 months (range 0 to 51). Health workers screened men for syphilis, chlamydia, and gonorrhea at enrollment and every 6 months.
While 40% of participants had no STIs during follow-up, smaller minorities accounted for the bulk of recorded STIs: 39% of men accounted 86% of all STIs, 14% accounted for 48% of all STIs, and the same 14% had four or more STIs during the study period. STI incidence was high during the double-blind phase of the trial, at 64.3 per 100 person-years in 2014. When the open-label phase began, STI incidence swelled to 89.6 per 100 person-years, a two-thirds jump from 2014 (1.68-fold, 95% confidence interval [CI] 1.39 to 2.03). For the entire study, STI incidence stood at 74.6 per 100 person-years (95% CI 68.99 to 80.6).
A Cox proportional hazards regression model identified four independent predictors of an STI during follow-up at the following hazard ratios (and 95% CI):
-- STI at baseline: HR 1.45 (1.11 to 1.89), P = 0.007
-- 8 or more sex partners: HR 1.39 (1.07 to 1.82), P = 0.015
-- Use of chemsex drug GHB (gamma hydroxybutyrate): HR 1.53 (1.15 to 2.04), P = 0.004
-- Use of erectile drugs: HR 1.32 (1.01 to 1.74), P = 0.045
The IPERGAY investigators suggest findings like these can help pinpoint PrEP users at very high risk for STIs. Health workers can then target them for interventions including further screening for risk behaviors and simplified access to STI testing and treatment.
Earlier, IPERGAY investigators reported a substudy showing that doxycycline postexposure prophylaxis trimmed chances of a first bacterial STI in MSM participants [4].
References
1. Zeggagh J, Bauer R, Delaugerre C, et al. Incidence and risk factors for STIs among MSM on PrEP: a post-hoc analysis of the ANRS IPERGAY trial. AIDS 2020: 23rd International AIDS Conference Virtual. July 6-10, 2020. Abstract PDB0302.
2. 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;373:2237-2246. doi: 10.1056/NEJMoa1506273.
3. Molina JM, Charreau I, Spire B, et al. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017;4:e402-e410. doi: 10.1016/S2352-3018(17)30089-9.
4. Molina JM, Charreau I, Chidiac C, et al. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018;18:308-317. doi: 10.1016/S1473-3099(17)30725-9.
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