Public Comment Period for Doxy PEP Guidelines

Cross-posted from: CDC Division of STD Prevention

Dear Colleagues,

CDC has developed draft guidelines on the use of sexually transmitted infection (STI) post-exposure prophylaxis with doxycycline (Doxy PEP) for preventing some bacterial STIs. Beginning Monday, October 2, the agency will request public input on the draft. Comments can be shared for 45 days on Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention. An informational presentation about the draft guidelines is available online.

The 2021 CDC STI Treatment Guidelines included a systematic review of the available literature on STI PEP and concluded that further studies were necessary to determine whether it would be an effective strategy for bacterial STI prevention. Since that time, promising results from several randomized trials on STI PEP indicated the need to re-address this topic. The new guidelines will offer an important resource for healthcare providers to inform the use of Doxy PEP for preventing bacterial STI infections.

STIs are pervasive and increasing rapidly in the U.S., and Doxy PEP has demonstrated substantial benefit in reducing new chlamydia, gonorrhea, and syphilis infections. Doxy PEP can benefit the health of some gay, bisexual, and other men who have sex with men, and transgender women who have increased chances of getting an STI. When offered, Doxy PEP should be implemented in the context of comprehensive sexual health. These draft guidelines represent a new approach to addressing STI prevention.

Once complete, the updated clinical guidelines for healthcare providers will inform the use of Doxy PEP for preventing bacterial STI infections. However, our work isn’t over after the guidelines are finalized. Important questions remain about the effectiveness of this approach for other populations, as well as potential long-term development of antimicrobial resistance and impacts on the microbiome. Given potential unknowns, CDC is calling for long-term monitoring and evaluation as more data become available.

Transparency and public feedback are crucial for effective public health and clinical guidelines, and broad, diverse perspectives will strengthen and improve the quality and use of the first new STI prevention tool in decades.

This step is part of a comprehensive process for ensuring the best possible guidelines, which has included:

• Development of immediate considerations for the use of Doxy PEP in July 2022.
• External and internal consultationsExit Disclaimer (PDF, 3.52MB) with experts.
• Review of the DoxyPEP trial resultsExit Disclaimer published in April 2023.
• Cross-agency review of proposed guidelines.

CDC now needs your input on the guidelines, and we are listening during this public comment period.

Thank you for your continued support.

Leandro Mena, MD, MPH, FIDSA
Director
Division of STD Prevention
National Center for HIV, Viral Hepatitis, STD and TB Prevention
Centers for Disease Control and Prevention