CDC Dear Colleague Message: Updated PrEP Guidelines

Content From: Demetre Daskalakis, MD, MPH, Director, Division of HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and PreventionPublished: December 08, 20214 min read


Cross-posted from Centers for Disease Control and Prevention

Demetre Daskalakis

Dear Colleague:

Today, the Centers for Disease Control and Prevention (CDC) published its updated ClinicalPractice Guideline for Preexposure Prophylaxis for HIV Prevention and Clinical Providers Supplement. The updated guideline and supplement reflect the latest science and are intended to help physicians effectively prescribe all FDA-approved pre-exposure prophylaxis (PrEP) medications to patients and increase PrEP use among all people who could benefit.

The overall goals of the revisions are to update existing guidance using the current evidence base, incorporate recent and potential FDA actions on PrEP medications, clarify specific aspects of clinical care, and improve usability and increase implementation of the guideline.

Key revisions to the guideline include:

  • A new recommendation for providers to inform all sexually active adults and adolescents about PrEP. This is intended to increase awareness of PrEP more broadly.
  • A recommendation that, in addition to taking a very brief history to identify persons with indications for PrEP, providers prescribe PrEP to anyone who requests it, even if they do not report specific HIV risk behaviors. This recommendation is intended to make PrEP available to people who may be apprehensive about sharing potentially stigmatized HIV risk behaviors with their provider.
  • A recommendation for F/TAF (Descovy) as an FDA-approved PrEP option for sexually active men and transgender women at risk of getting HIV, based on recent data showing its effectiveness for these populations.
  • A new section on prescribing bimonthly intramuscular injections of cabotegravir (CAB) for sexually active men and women who could benefit from PrEP, pending FDA data review and potential regulatory action.
  • Updated HIV testing recommendations that incorporate the latest and most effective methods for quickly detecting HIV infection among people using any PrEP medication.
    • Specifically, it includes a recommendation that providers now require the following for people who have taken oral PrEP in the last three months or who have received a CAB injection in the last 12 months:
      • a positive antigen/antibody test and a detectable HIV-1 RNA test to confirm an HIV infection before transitioning the patient to an HIV treatment regimen; or
      • a negative antigen/antibody test and an undetectable HIV-1 RNA test before confirming the absence of an HIV infection to continue prescribing PrEP.

Please note there are no changes to the guideline regarding populations for whom PrEP is recommended nor to the section of the guideline pertaining to recommended daily dosing regimens for oral PrEP. There are also no changes to the sections of the guideline regarding frequency of HIV and sexually transmitted infection (STI) testing for daily oral PrEP.

PrEP is one of the most powerful tools we have to prevent HIV transmission. Expanding access to PrEP will be critical to ending the HIV epidemic in the United States. CDC is committed to increasing the use of PrEP by funding high-impact HIV prevention programs for health departments and non-clinical and clinical community-based organizations around the country, including through the federal Ending the HIV Epidemic (EHE) in the U.S. initiative.

CDC programs are designed to increase PrEP awareness and demand by funding: local organizations to conduct community-based outreach to people who could benefit most including gay and bisexual men of color, people in the South, Black women, transgender women, and persons who inject drugs; education campaigns that increase awareness and combat stigma associated with PrEP use; and tools such as CDC’s PrEP Locator, which has information on public and private providers who offer PrEP.

CDC also aims to increase accessibility of PrEP through healthcare provider training, provider education campaigns, clinical guideline development, and by working with partners to offer PrEP and related services through primary care clinics, sexually transmitted disease (STD) clinics, TelePrEP services, pharmacies, and school-based health centers.

We have a once-in-a-generation opportunity to end the HIV epidemic in the United States, but to do so, we must maximize the use of effective prevention tools, such as PrEP. As the nation’s leading HIV prevention agency, CDC is committed to working with providers, partners, and communities across the country to increase the implementation of this updated guideline and increase the uptake of PrEP to reach our shared goal of reducing new HIV infections by 90% by 2030.


<Demetre Daskalakis>
Demetre C. Daskalakis, MD, MPH
Division of HIV Prevention
National Center for HIV, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention