DoxyPEP
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
96.0% male
N = 501
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
10.7%
31.9%
31.9 %
23.9 %
15.9 %
8.0 %
0.0 %
Doxycycline
Standard
care
Significant
decrease ▼
NNT = 4
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 HIV infection cohort (11.8% vs. 30.5%; RR 0.38, 95% CI 0.24 to 0.6).
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).
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.
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