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The PrEP Guidelines Center

Review the latest recommendations with

David Malebranche, MD, MPH and Ariel Watriss, MSN, NP-C

Dr. Malebranche (he/him/his), an internal medicine specialist with expertise in sexual health and HIV/STI prevention and treatment, is a clinician at the AIDS Healthcare Foundation Health Care Center in midtown Atlanta

Ariel Watriss (she/her/hers) is a college health nurse practitioner at Tufts University in Boston, and a renowned sexual health clinician and educator

SUMMARY:

The Centers for Disease Control and Prevention (CDC) makes recommendations for the use of PrEP as biomedical HIV prevention. Based on a systematic review of the literature through June 2017, these evidence-based guidelines offer a practical approach to identifying patients who would be appropriate candidates for PrEP, ordering relevant tests and laboratory procedures, and how to conduct initial and follow-up visits for patients. Given the evolving nature of PrEP research, these recommendations will be revised and updated for clinical practice on a regular basis. This section will also review other supportive guidelines and statements from ACOG and USPSTF

General Guidelines for PrEP 

Safety and Efficacy

PrEP, when used as indicated, has been determined to be safe and effective in the prevention of HIV transmission among diverse populations

  • Men who have sex with men and transgender women: 92% to 100% reduction in HIV transmission in clinical trials and real-world analysis
  • Heterosexual women and men – 63% to 93% reduction in HIV transmission
  • Persons who Inject Drugs (PWID) – 73.5% reduction in HIV transmission
  • Adolescents who weigh over 35kg – over 95% reduction in HIV transmission

Eligibility

The United States Prevention Services Task Force (USPSTF) recommends offering PrEP with effective antiretroviral therapy to persons at high risk of HIV acquisition

  • FDA approved when one pill taken once a day
  • Either F/TDF 200/300mg (Truvada) or F/TAF 200/25 (Descovy) are currently approved for use
  • Insurance must provide medication coverage for preventive services with Grade A recommendation

CDC Guidelines for Screening Eligibility

The CDC describes patients falling into categories of “risk groups” with regards to which of your patients would be good candidates for PrEP. We caution against seeing patients as levels of “risk,” particularly when it comes to sexual health. What it involves is taking a good sexual history and documenting what behavioral choices they make, then offering PrEP as an option for HIV prevention.

PrEP is for people without HIV who could be exposed to HIV from sex or injection drug use.

CDC recommends the following should be assessed for PrEP including:

  • Sexually active gay and bisexual men without HIV
  • Sexually active heterosexual men and women without HIV
  • Sexually active transgender persons without HIV
  • Persons without HIV who inject drugs
  • Persons who have been prescribed non-occupational post-exposure prophylaxis (PEP) and report behaviors that could expose them to HIV, or who have used multiple courses of PEP

For sexually active adults and adolescents:

  • Anal or vaginal sex in the past 6 months; and
  • HIV-positive sexual partner (especially if partner has unknown or detectable viral load); or
  • Recent bacterial STI; or
  • History of inconsistent or no condom use with sexual partner(s)

For Persons who inject drugs:

  • HIV-positive injecting partner; or
  • Shares drug preparation or injection equipment

All persons eligible for PrEP:

  • Documented negative HIV test result before prescribing PrEP; and
  • No signs/symptoms of acute HIV infection; and
  • Normal renal function; and
  • No contraindicated medications

Note: While the CDC compartmentalizes “risk groups” as listed above, clinicians should remember that sexual health does not fit neatly into static compartments. Sexuality and sexual behavior are fluid, and individuals may change their partners, behavior, and condom use over time and situations.

Other Considerations

Follow-up

Patients taking PrEP can be followed closely by medical staff who are both clinical and non-clinical to assure proper usage and safety

  • Current recommended follow-up every three months
  • Use of in-person and telemedicine visits
  • Specific laboratory testing is indicated upon initial visit and subsequent follow-up

Women’s Health

The American College of Obstetricians and Gynecologists (ACOG) recommends providers working with women at risk of HIV transmission be aware and up to date on this preventative health tool and encourage strong adherence as key to its effectiveness

Future Directions

Future delivery systems of PrEP are in various stages of clinical development and research and will likely become available as options in the future:

  • Long acting injectables
  • Implants
  • Long-acting oral agents
  • Patches

Learn More – Primary Sources:

CDC Guidelines Pre-Exposure Prophylaxis

National Clinician Consulting Center: PrEP: Pre-Exposure Prophylaxis

National Institute of Health (NIH): Pre-Exposure Prophylaxis (PrEP)

NIH guidelines for clinicians on PrEP among individuals who are trying to conceive or are pregnant, postpartum, or breastfeeding

World Health Organization (WHO) compendium of PrEP publications

ACOG: Preexposure Prophylaxis for the Prevention of Human Immunodeficiency Virus

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

David Malebranche, MD, MPH serves on the PrEP speakers bureau for Gilead Sciences, Inc 

Ariel Watriss, MSN, NP-C has no relevant financial relationships to disclose