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June 04, 2024
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CDC recommends clinicians counsel certain patients about doxy-PEP for STI prevention

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Key takeaways:

  • The CDC says clinicians should counsel gay, bisexual and other MSM and transgender women about doxy-PEP.
  • There are no recommendations for other populations because of a lack of evidence.

The CDC has published guidance recommending that providers counsel certain patients on the harms and benefits of doxycycline for post-exposure prophylaxis — or doxy-PEP — for the prevention of sexually transmitted infections.

The recommendations are based on promising evidence showing that doxy-PEP is effective at preventing STIs.

IDN0624Bachmann_Graphic_01_WEB
Derived from the CDC.

“No vaccines and few chemoprophylaxis options exist for the prevention of bacterial STIs (specifically syphilis, chlamydia, and gonorrhea),” Laura H. Bachmann, MD, chief medical officer of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, and colleagues wrote. “These infections have increased in the United States and disproportionately affect gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW).”

Although doxycycline, a broad-spectrum tetracycline antimicrobial, has already been proven as a good option for the prevention of infections such as malaria and Lyme disease, it has not been used to prevent STIs until recently.

Now, the CDC is recommending that providers counsel all gay, bisexual and other MSM and TGW with a history of at least one bacterial STI — specifically syphilis, chlamydia or gonorrhea — during the past 12 months about the benefits and harms of using doxycycline within 72 hours of oral, vaginal or anal sex.

They should also offer doxy-PEP through shared decision-making in the context of a “comprehensive sexual health approach,” including risk reduction counseling, STI screening and treatment, recommended vaccination and linkage to HIV PrEP, HIV care or other services as appropriate.

As part of the recommendation, a patient’s ongoing need for doxy-PEP should be assessed every 3 to 6 months.

Evidence supporting doxy-PEP

An open-label extension phase of the French IPERGAY study evaluated the efficacy doxy-PEP in a single cohort of 232 HIV-negative MSM and TGW taking PrEP for HIV prevention. Participants were randomly assigned to take either a single oral dose of 200 mg doxycycline, ideally within 24 hours but no later than 72 hours after having condomless anal or oral sex up to three times per week, or no medication prophylaxis. The study showed that patients who took doxy-PEP had a reduced risk for acquiring chlamydia and syphilis of 70% (HR = 0.3; 95% CI, 0.13-0.7) and 73% (HR = 0.27; 95% CI, 0.07-0.98), respectively, although researchers found no significant difference in rates of gonorrhea infections between the two groups.

Additionally, a randomized open-label clinical trial in San Francisco and Seattle enrolled 501 MSM and TGW who either had HIV or were taking HIV PrEP and had a history of condomless sex or one or more STIs during the previous 12 months. It showed that self-administered oral doxycycline significantly reduced the incidence of chlamydia, gonorrhea and syphilis. Specifically, the study demonstrated risk reductions for gonorrhea among people taking HIV PrEP (RR = 0.45; 95% CI, 0.34-0.65) and those with HIV infection (RR = 0.43; 95% CI, 0.26-0.71), as well as reduced risks for chlamydia (RR = 0.12; 95% CI, 0.05-0.25 and RR = 0.26; 95% CI, 0.12-0.57, respectively) and early syphilis (RR = 0.13; 95% CI, 0.03-0.59 and RR = 0.23; 95% CI, 0.04-1.29, respectively).

The French ANRS DOXYVAC study enrolled 502 MSM who were taking HIV PrEP for at least 6 months and had at least one STI in the 12 months before enrollment. The trial was ultimately stopped early because after it demonstrated that doxy-PEP was associated with significant reductions in gonorrhea (adjusted aHR = 0.49; 95% CI, 0.32-0.76), chlamydia (aHR = 0.11; 95% CI, 0.04-0.3) and syphilis (aHR = 0.21; 95% CI, 0.09-0.47).

While an additional study in Kenya assessed doxy-PEP use in cisgender women, researchers found the efficacy data to be lacking, so the CDC is not providing a recommendation on its use in that population. Similarly, insufficient data exist for cisgender heterosexual men, transgender men and other queer and nonbinary people, leading the CDC to leave these populations out of recommendations for now.

“The available evidence in the context of increased national incidence of syphilis, chlamydia and gonorrhea supports consideration of this approach for MSM and TGW at substantial risk for acquiring bacterial STIs,” the authors wrote. “These guidelines will be updated as additional data become available.”