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Complera well-tolerated as PEP in MSM
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A single-tablet regimen of Complera was well-tolerated by men who have sex with men as daily HIV post-exposure prophylaxis, according to recent findings.
In the open-label, nonrandomized trial, researchers evaluated 100 MSM referred for possible post-exposure prophylaxis (PEP) at four centers in Sydney and Melbourne, Australia. Participants were aged 18 years or older, HIV-uninfected and eligible for PEP due to unprotected anal intercourse with a known HIV-positive individual. They were given a single-tablet regimen (STR) of Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate, Gilead Sciences; FTC/RPV/TDF) once daily with meals for 28 days. Participants were followed for 12 weeks and attended up to seven study visits.
The study’s primary endpoint was the proportion of participants who prematurely discontinued PEP (before day 28) or primary HIV infection up to week 12. Secondary endpoints included compliance to treatment regimen and regimen safety.
The researchers found that FTC/RPV/TDF yielded a 92% completion rate (95% CI, 85%-96%), with premature discontinuation attributable to loss to follow-up (6%), adverse event (1%) and study burden (1%). None of the tested participants (n = 70) contracted HIV by the final study visit.
Adherence as measured by pill count was 98.6%, and self-reported adherence was 98.5%. The self-reported rate of taking all doses with food was 86%, and of the subset tested for plasma concentrations, 88% had plasma tenofovir concentrations that reflected full compliance ( > 40 ng/mL). At least one clinical adverse event occurred in 88 participants; four were grade 3+, and 56 participants experienced at least one laboratory adverse event, four of which were grade 3+ that may have been related to the treatment regimen.
According to the researchers, the completion and adherence rates seen in their analysis compared favorably with previous PEP studies.
“STR FTC/RPV/TDF was well-tolerated as once-daily PEP, with high levels of adherence and completion,” the researchers wrote. “Other STRs should be evaluated as PEP.” – by Jen Byrne
Disclosure: Foster reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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