CDC Response to Doxy-PEP data presented at 2022 International AIDS Conference

July 27, 2022 – CDC Response to presentation of Doxy-PEP clinical trial data at 2022 International AIDS Conference

More tools are needed in the nation’s fight against bacterial STIs given the increasing burden of gonorrhea, chlamydia, and syphilis infections in the U.S. We are encouraged by the initial data from the NIH-funded study on the use of doxycycline post-exposure prophylaxis (doxy-PEP) to prevent these infections. The first look at the data presented at the 2022 International AIDS Conference showed doxy-PEP demonstrated significant effectiveness and tolerability against these common STIs in gay and bisexual men and transgender women with HIV or taking HIV pre-exposure prophylaxis (PrEP) over the course of this study.

The findings indicate this approach has the potential to be an additional option to prevent these bacterial STIs among some individuals at substantial risk for repeated STI acquisition. We look forward to seeing additional data from the study to evaluate the potential individual and public health risks of doxy-PEP. For example, participant data on the change in doxycycline resistance in other common bacteria found in or on the body, including staph.

Further review of the data presented, and potentially additional analyses, will be needed to develop clinical guidance on the safe and effective use of this strategy for bacterial STI prevention among gay and bisexual men and transgender women. It will be critical to provide guidance that will maximize effectiveness for STI prevention, while minimizing both individual and potential public health risks.

We must move quickly to implement powerful STI prevention strategies. And it is our public health imperative to develop responsible guidance, based on a careful consideration of all available data and public health risks and benefits – we cannot take short cuts when it comes to people’s health.

In the coming months, CDC in collaboration with trial investigators and other partners, will be reviewing the data, both to develop interim clinical guidance, as well as to outline key additional research questions moving forward.

Research questions on this topic will address:

• Clarifying frequency/population with which desired efficacy is reached
• Understanding the individual health risks vs. benefits
• Weighing the public health risks vs. benefits
• Determining optimal groups for this targeted intervention

Considerations for individuals and healthcare providers of gay or bisexual men or transgender women currently evaluating doxy-PEP as an STI prevention strategy can be found at CDC STD treatment guidelines website.

While bacterial STIs have been increasing for nearly a decade, we know that some population groups, including gay and bisexual men, continue to experience a higher burden of infection. These disparities are tied to a range of factors, many of them longstanding, such as lack of access to regular medical care, discrimination, and stigma, which continue to stand in the way of quality sexual healthcare for everyone who needs it.

Doxy-PEP as a targeted intervention for bacterial STIs has the potential to reduce STI acquisition and transmission. To reduce health disparities, it will be critical for providers and the public health community to consider existing barriers to sexual health services and prioritize considerations for equitable access to this potential prevention strategy. This includes seeking out new information as it becomes available and engaging in shared decision-making with patients who may benefit from doxy-PEP.