6/28/23, 1:21 AM DoxyPEP Pathway Feedback Search Clinical Topics Home Studies DoxyPEP DoxyPEP Disease Disease Chlamydia trachomatis infection Syphilis infection Trial question What is the role of doxycycline postexposure prophylaxis among MSM and transgender women with recent bacterial STIs? Study design Multi-center Open label RCT Population Characteristics of study participants 4.0% female N = 501 96.0% male 501 patients (19 female, 482 male) Inclusion criteria: MSM and transgender women with bacterial STIs in the previous 12 months Key exclusion criteria: tetracycline allergy; receipt of medications with drug interactions with doxycycline; plan for receipt of doxycycline for an extended period Interventions N=339 doxycycline (at a dose of 200 mg within 72 hours of condomless sex) N=162 standard care (standard of care without the use of doxycycline) Primary outcome Any sexually transmitted infections per follow-up quarter, in pre-exposure prophylaxis cohort https://web.pathway.md/studies/recy6c1gUyrRv4Txw 1/2 6/28/23, 1:21 AM DoxyPEP Pathway 31.9 % 31.9 23.9 % 15.9 % Significant decrease 10.7 8.0 % NNT = 5 0.0 % Doxycycline Standard care Significant decrease in any STIs per follow-up quarter, in pre-exposure prophylaxis cohort (10.7% vs. 31.9%; RR 0.34, 95% CI 0.24 to 0.46) Secondary outcomes Significant decrease in STIs per follow-up quarter, in persons living with human immunodeficiency virus infection cohort (11.8% vs. 30.5%; RR 0.38, 95% CI 0.24 to 0.6) Borderline significant decrease in gonorrhea infection in pre-exposure prophylaxis cohort (9.1% vs. 20.2%; RR 0.45, 95% CI 0.32 to 0.65) Borderline significant decrease in chlamydia infection in pre-exposure prophylaxis cohort (1.4% vs. 12.1%; RR 0.12, 95% CI 0.05 to 0.25) Safety outcomes No significant difference in adverse events. Conclusion In MSM and transgender women with bacterial STIs in the previous 12 months, doxycycline was superior to standard care with respect to any STIs per follow-up quarter, in pre-exposure prophylaxis cohort. Reference Anne F Luetkemeyer, Deborah Donnell, Julia C Dombrowski et al. Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections. N Engl J Med. 2023 Apr 6;388(14):1296-1306. Open reference URL https://web.pathway.md/studies/recy6c1gUyrRv4Txw 2/2