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Postexposure Doxycycline to Prevent
Bacterial Sexually Transmitted Infections
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The oral antibiotic doxycycline prevented the acquisition of sexually transmitted infections (STIs) when tested among men who have sex with men (MSM) and transgender women who took the medication within 72 hours of having condomless sex, according to findings published today in the New England Journal of Medicine. Specifically, the post-exposure approach, termed doxy-PEP, resulted in a two-thirds reduction in the incidence of syphilis, gonorrhea, and chlamydia among the study participants, all of whom reported having an STI within the previous year. However, the research also revealed a slight increase in antibacterial resistance that requires further exploration, the authors found. The research was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
"Effective methods for preventing sexually transmitted infections are badly needed," said Hugh Auchincloss, M.D., NIAID acting director. "This is an encouraging finding that could help reduce the number of sexually transmitted infections in populations most at-risk."
"Given its demonstrated efficacy in several trials, doxy-PEP should be considered as part of a sexual health package for men who have sex with men and transwomen if they have an increased risk of STIs," according to Annie Luetkemeyer, M.D., professor of infectious diseases at Zuckerberg San Francisco General Hospital at UCSF, and co-principal investigator of the study. "It will be important to monitor the impact of doxy-PEP on antimicrobial resistance patterns over time and weigh this against the demonstrated benefit of reduced STIs and associated decreased antibiotic use for STI treatment in men at elevated risk for recurrent STIs."
"We need new, effective STI prevention methods and three studies have now demonstrated that doxy-PEP significantly reduces gonorrhea, chlamydia and syphilis. In the next several years during the implementation of doxy-PEP, we need to learn about maximizing equitable access and impact," said Dr. Connie Celum, Professor of Global Health and Medicine at the University of Washington and co-principal investigator of the DoxyPEP Study.
NIH-funded study finds doxycycline reduces sexually transmitted infections by two-thirds
04/06/2023 05:00 PM EDT
April 6, 2023
NEJM Luetkemeyer et al.
Abstract
Background
Interventions to reduce sexually transmitted infections (STIs) among men who have sex with men (MSM) are needed.
Methods
We conducted an open-label, randomized study involving MSM and transgender women who were taking preexposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection (PrEP cohort) or living with HIV infection (persons living with HIV infection [PLWH] cohort) and who had had Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), or syphilis in the past year. Participants were randomly assigned in a 2:1 ratio to take 200 mg of doxycycline within 72 hours after condomless sex (doxycycline postexposure prophylaxis) or receive standard care without doxycycline. STI testing was performed quarterly. The primary end point was the incidence of at least one STI per follow-up quarter.
Results
Of 501 participants (327 in the PrEP cohort and 174 in the PLWH cohort), 67% were White, 7% Black, 11% Asian or Pacific Islander, and 30% Hispanic or Latino. In the PrEP cohort, an STI was diagnosed in 61 of 570 quarterly visits (10.7%) in the doxycycline group and 82 of 257 quarterly visits (31.9%) in the standard-care group, for an absolute difference of -21.2 percentage points and a relative risk of 0.34 (95% confidence interval [CI], 0.24 to 0.46; P<0.001). In the PLWH cohort, an STI was diagnosed in 36 of 305 quarterly visits (11.8%) in the doxycycline group and 39 of 128 quarterly visits (30.5%) in the standard-care group, for an absolute difference of -18.7 percentage points and a relative risk of 0.38 (95% CI, 0.24 to 0.60; P<0.001).
The incidences of the three evaluated STIs were lower with doxycycline than with standard care; in the PrEP cohort, the relative risks were 0.45 (95% CI, 0.32 to 0.65) for gonorrhea, 0.12 (95% CI, 0.05 to 0.25) for chlamydia, and 0.13 (95% CI, 0.03 to 0.59) for syphilis, and in the PLWH cohort, the relative risks were 0.43 (95% CI, 0.26 to 0.71), 0.26 (95% CI, 0.12 to 0.57), and 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 gonorrhea culture available, tetracycline-resistant gonorrhea occurred in 5 of 13 in the doxycycline groups and 2 of 16 in the standard-care groups.
Conclusions
The combined incidence of gonorrhea, chlamydia, and syphilis was lower by two thirds with doxycycline postexposure prophylaxis than with standard care, a finding that supports its use among MSM with recent bacterial STIs. (Funded by the National Institutes of Health; DoxyPEP ClinicalTrials.gov number,
NCT03980223. opens in new tab.)
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