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In the IPERGAY trial, MSM were to take two pills two to 24 hours before first sexual activity, followed by one pill taken daily until 48 hours after the last sexual activity. The RCT phase of IPERGAY found an 86% reduced risk of HIV infection among MSM in the on-demand PrEP group compared to those in a placebo group (two participants in the PrEP arm became infected). Men in the RCT phase of this study had sex frequently and – as a result – took their pills on a regular basis (four pills a week on average). IPERGAY continued as an open-label extension with all participants offered on-demand PrEP. Results from the open-label phase showed that one more HIV transmission occurred in 362 participants, over 515 person-years of follow-up (equivalent to following 515 people for one year). None of the three participants who became infected over the entire course of the study had PrEP detected in their blood, which means they were likely not adherent. On-demand PrEP has only been evaluated in MSM and is not recommended for people who have vaginal sex or people who inject drugs.
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