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The combined incidence of gonorrhea, chlamydia, and syphilis was cut by two-thirds among men who have sex with men (MSM) and transgender women who were taking doxycycline post-exposure prophylaxis (doxy-PEP), according to the results of a randomized trial published today in the New England Journal of Medicine.
The open-label randomized trial involved 501 MSM and transgender women (67% White, 30% Hispanic or Latino, 11% Asian or Pacific Islander, 7% Black) who were taking post-exposure prophylaxis against HIV (the PrEP cohort) or were persons living with HIV (the PLWH cohort) and had had gonorrhea, chlamydia, or syphilis infections in the past year.
The participants were randomly assigned in a 2:1 ratio to take 200 milligrams of doxycycline within 72 hours of condomless sex or receive standard care. Participants underwent quarterly sexually transmitted infection (STI) testing, and the primary outcome was the incidence of at least one STI per quarter.
The incidences of the three evaluated STIs were lower with doxycycline than with standard care. In the PrEP cohort (327 participants), the incidence of gonorrhea fell by 55% (relative risk [RR], 0.45; 95% confidence interval [CI], 0.32 to 0.65), chlamydia by 88% (RR, 0.12; 95% CI, 0.05 to 0.25), and syphilis by 87% (RR, 0.13; 95% CI, 0.03 to 0.59) among those taking doxycycline. In the PLWH cohort (174 participants), incidence fell by 47% (RR, 0.43; 95% CI, 0.26 to 0.71), 74% (RR, 0.26; 95% CI, 0.12 to 0.57), and 77% (RR, 0.23; 95% CI, 0.04 to 1.29), respectively.
Five grade 3 adverse events and no serious adverse events were attributed to doxycycline. Of the participants with available gonorrhea cultures, tetracycline-resistant gonorrhea occurred in 5 of 13 in the doxycycline groups and 2 of 16 in the standard-care groups.
The efficacy of the intervention led the data and safety monitoring board to stop the trial early in May 2022 and recommend that all participants be offered doxy-PEP. The results were initially announced at the 2022 International AIDS Conference.
“These results showed effectiveness of doxy-PEP among MSM regardless of HIV status in a socioeconomically and racially diverse population,” the trial investigators wrote.
