Notice2023-21725
Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention; Request for Comment and Informational Presentation
Primary source
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Published
October 2, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on proposed guidelines for the use of doxycycline post-exposure prophylaxis (PEP) for prevention of bacterial sexually transmitted infections (STI). The proposed guidelines for bacterial STI prevention include post-exposure prophylaxis with doxycycline (doxycycline PEP) because it has demonstrated benefit in reducing chlamydia, gonorrhea, and syphilis infections and represents a new approach to addressing STI prevention in populations at increased risk for these infections. Doxycycline PEP, when offered, should be implemented in the context of a comprehensive sexual health approach including risk reduction counseling, STI screening and treatment, recommended vaccination, and linkage to HIV pre-exposure prophylaxis (PrEP), HIV care, or other services, as appropriate. The purpose of the proposed guidelines is to provide updated clinical guidance for healthcare providers to inform the use of doxycycline PEP for preventing bacterial STI infections. CDC has made available a pre- recorded informational presentation to provide information about the studies considered when developing the proposed guideline, explain the public comment process, and provide an overview of important monitoring for antibiotic use and antibiotic resistance that the agency will be considering to address potential risks.
Full Text
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<title>Federal Register, Volume 88 Issue 189 (Monday, October 2, 2023)</title>
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[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67754-67755]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21725]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2023-0080]
Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis
for Bacterial Sexually Transmitted Infection (STI) Prevention; Request
for Comment and Informational Presentation
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) announces the opening of
a docket to obtain comment on proposed guidelines for the use of
doxycycline post-exposure prophylaxis (PEP) for prevention of bacterial
sexually transmitted infections (STI). The proposed guidelines for
bacterial STI prevention include post-exposure prophylaxis with
doxycycline (doxycycline PEP) because it has demonstrated benefit in
reducing chlamydia, gonorrhea, and syphilis infections and represents a
new approach to addressing STI prevention in populations at increased
risk for these infections. Doxycycline PEP, when offered, should be
implemented in the context of a comprehensive sexual health approach
including risk reduction counseling, STI screening and treatment,
recommended vaccination, and linkage to HIV pre-exposure prophylaxis
(PrEP), HIV care, or other services, as appropriate. The purpose of the
proposed guidelines is to provide updated clinical guidance for
healthcare providers to inform the use of doxycycline PEP for
preventing bacterial STI infections. CDC has made available a pre-
recorded informational presentation to provide information about the
studies considered when developing the proposed guideline, explain the
public comment process, and provide an overview of important monitoring
for antibiotic use and antibiotic resistance that the agency will be
considering to address potential risks.
DATES: Written comments must be received on or before November 16,
2023. An Informational Presentation has been pre-recorded and is
available at <a href="https://npin.cdc.gov/">https://npin.cdc.gov/</a>.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0080 by either of the methods listed below. Do not submit comments by
email. CDC does not accept comments by email.
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: [Division of STD Prevention, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop US12-2, Atlanta,
GA 30329, Attn: Docket No. CDC-2023-0080].
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to <a href="http://regulations.gov">http://regulations.gov</a>, including any personal
information provided. For access to the docket to read background
documents or comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
The informational presentation can be accessed at <a href="https://npin.cdc.gov/">https://npin.cdc.gov/</a>.
FOR FURTHER INFORMATION CONTACT: John R. Papp, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop U12-3, Atlanta,
GA 30329; Telephone: 404-639-8000; Email: <a href="/cdn-cgi/l/email-protection#4c263b3c7a0c2f282f622b233a"><span class="__cf_email__" data-cfemail="711b060147311215125f161e07">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: CDC's proposed guidelines for the use of
post-exposure prophylaxis with doxycycline for bacterial STI prevention
in the United States is available under the Supporting and Related
Materials tab in the docket for this notice, Docket No. CDC-2023-0080,
on <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data. In addition, CDC
invites comments specifically on the following questions proposed in
this Notice:
<bullet> Based on the evidence presented in the full guidelines
document (see the Supporting and Related Materials tab in the docket),
does the evidence support the proposed guidelines for the use of post-
exposure prophylaxis with doxycycline for bacterial STI prevention,
including but not limited to risks and benefits? If not, please state
the reason why and, if available, provide additional evidence for
consideration.
<bullet> Are CDC's proposed guidelines for the use of post-exposure
prophylaxis with doxycycline bacterial STI prevention clearly written?
If not, what changes do you propose to make it clear?
<bullet> If implemented as currently drafted, do you believe the
proposed guidelines for the use of post-exposure prophylaxis with
doxycycline for bacterial STI prevention would result in improved
prevention of bacterial STIs in the United States? If not, please
provide an explanation and supporting data or evidence.
<bullet> How can these proposed guidelines most effectively reach
and be received by populations who would benefit from this
intervention?
Please note that comments received, including attachments and other
supporting materials, are part of the public record and are subject to
public disclosure. Comments will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Therefore, do not include any information in your
comment or supporting materials that you consider confidential or
inappropriate for public disclosure. If you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be on public display. CDC will
review all submissions and may choose to redact, or withhold,
submissions containing private or proprietary information such as
Social Security numbers, medical information, inappropriate language,
or duplicate/near duplicate examples of a mass-mail campaign.
Background
Incidence of sexually transmitted infections (STIs) caused by
Neisseria gonorrhoeae (causative agent of gonorrhea), Chlamydia
trachomatis (causative agent of chlamydia), and Treponema pallidum
(causative agent of syphilis) continues to increase in the United
States. Novel approaches are needed to address the STI epidemic,
especially for populations disproportionately affected (1). Post-
exposure prophylaxis (PEP) involves taking a medication to prevent an
infection after a possible exposure and is a common strategy for
prevention of HIV and other infections. PEP is a form of
chemoprophylaxis and distinct from pre-exposure prophylaxis (PrEP)
which involves taking a medication before exposure occurs. Doxycycline,
a broad-spectrum tetracycline antibiotic, is used as pre- or post-
exposure prophylaxis to prevent infections such as malaria and Lyme
disease (2). Doxycycline is well
[[Page 67755]]
absorbed and tolerated, with a half-life of approximately 12 hours (3).
Adverse effects most associated with doxycycline are photosensitivity
and gastrointestinal symptoms including esophageal erosion and
ulceration (4). Most adverse effects resolve when the medication is
stopped. Doxycycline is the recommended treatment regimen for chlamydia
and an alternative treatment for syphilis in non-pregnant patients with
severe penicillin allergy or when penicillin is not available (5).
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 (5). Since that time, promising
results from several randomized trials on doxycycline PEP indicated the
need to re-address this topic (6, 7). The new guidelines will offer an
important resource for healthcare providers to inform the use of
doxycycline PEP for preventing bacterial STI infections. CDC plans to
use multiple surveillance systems to monitor impacts of the proposed
guidelines including potential impacts on antibiotic use and antibiotic
resistance in both STI and non-STI pathogens.
All comments received will be carefully reviewed and considered.
The proposed guidelines are also undergoing peer review. All comments
will be addressed in the final guidelines and the proposed guidelines
will be revised as appropriate. CDC will publish another notice
announcing the availability of the final guidelines.
References
1. STI National Strategic Plan, 2021-2025 [internet]. Available
from: <a href="http://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html">www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html</a>.
2. Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna
D, et al. Prophylaxis with single-dose doxycycline for the
prevention of Lyme disease after an Ixodes scapularis tick bite. N
Engl J Med. 2001 Jul 12;345(2):79-84.
3. Peyriere H, Makinson A, Marchandin H, Reynes J. Doxycycline in
the management of sexually transmitted infections. J Antimicrob
Chemother. 2018 Mar 1;73(3):553-63.
4. Sloan B, Scheinfeld N. The use and safety of doxycycline hyclate
and other second-generation tetracyclines. Expert Opin Drug Saf.
2008 Sep;7(5):571-7.
5. Workowski K, Bachmann L, Chan P, Johnston C, Muzny C, Park I, et
al. Sexually Transmitted Infections Treatment Guidelines, 2021.
MMWR. 2021; 70:1-187.
6. Luetkemeyer AF, Donnell D, Dombrowski JC, Cohen S, Grabow C,
Brown CE, et al. Postexposure Doxycycline to Prevent Bacterial
Sexually Transmitted Infections. N Engl J Med. 2023 Apr
6;388(14):1296-306.
7. Jean-Michel Molina, Beatrice Bercot, Lambert Assoumou, Algarte-
Genin Michele, Emma Rubenstein, Gilles Pialoux, et al. ANRS 174
DOXYVAC: An Open-Label Randomized Trial to Prevent STIs in MSM on
PrEP. CROI [internet]. 2023 Feb 19; Seattle, Washington. Available
from: <a href="https://www.croiconference.org/abstract/anrs-174-doxyvac-an-open-label-randomized-trial-to-prevent-stis-in-msm-on-prep/">https://www.croiconference.org/abstract/anrs-174-doxyvac-an-open-label-randomized-trial-to-prevent-stis-in-msm-on-prep/</a>.
Dated: September 27, 2023.
Kathryn L. Wolff,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2023-21725 Filed 9-29-23; 8:45 am]
BILLING CODE 4163-18-P
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