What are the CDC guidelines on preexposure prophylaxis (PrEP) against HIV infection?

Updated: Oct 08, 2019
  • Author: Alejandro Delgado, MD; Chief Editor: Michael Stuart Bronze, MD  more...
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PrEP treatment guidelines include:

  • Acute and chronic HIV infection must be excluded by symptom history and HIV testing immediately before PrEP is prescribed; evidence level IA

  • The only medication regimen approved by the FDA and recommended for PrEP with all the populations specified in the CDC guideline is daily TDF 300 mg coformulated with FTC 200 mg (Truvada); evidence level IA

  • TDF alone has shown substantial efficacy and safety in trials with IDUs and heterosexually active adults and can be considered as an alternative regimen for these populations, but not for MSM, among whom its efficacy has not been studied; evidence level IC

  • Use of other ART medications for PrEP, either in place of or in addition to TDF/FTC (or TDF) is not recommended; evidence level IIIA

  • Oral PrEP for coitally-timed or other noncontinuous daily use is not recommended; evidence level IIIA

Based on the iPrEx results, interim CDC guidelines were issued in January 2011 for emtricitabine/tenofovir for use as PrEP among men who have sex with men (MSM) who continue to engage in high-risk behaviors. The use of tenofovir/emtricitabine may be considered on a case-by-case basis, with the clinician fully explaining the limitations of such an intervention. These guidelines only applied to MSM who continue to engage in high-risk behavior and did not apply to other at-risk populations (eg, injection drug users, heterosexuals, or serodiscordant couples). [4]

When considering MSM for initiation of PrEP medications, it is important to evaluate for inconsistent use of other effective risk-reduction measures (eg, condom use), as well as ascertain that the risk for HIV acquisition is high (eg, frequent partner change or concurrent partners in a geographic setting with high HIV prevalence); these patients might benefit most from the addition of PrEP to their HIV prevention regimen. PrEP should not be started in persons with signs or symptoms of acute viral infection unless HIV-uninfected status is confirmed by HIV RNA testing or a repeat antibody test performed after the viral syndrome resolves to reduce the risk of transmission of drug resistance.

Following the publication of final results from the TDF2 and Partners PrEP trials in August 2012, the CDC published interim guidance to help clinicians safely and effectively provide PrEP for heterosexually-active adults. This guidance included recommendations similar to those for MSM, as well as new recommendations relevant to women who may become pregnant while taking PrEP and to serodiscordant couples. [5]

Results from a randomized controlled trial showed tenofovir disoproxil fumarate (TDF, Viread) 300 mg/day was effective in reducing the acquisition of HIV infection among injecting drug users (IDUs). [18] Based on these findings, the CDC updated its interim guidance for PrEP and now recommends that tenofovir/emtricitabine (TDF/FTC, Truvada) be considered as one of several prevention options for persons at very high risk for HIV acquisition through the injection of illicit drugs. [6]

TDF/FTC was FDA-approved for PrEP against sexual HIV acquisition by MSM, and in heterosexually-active serodiscordant women and men in July 2012 and contains the same dose of tenofovir used in the June 2013 trial by Choopanya et al. Although use of TDF/FTC without sexual HIV acquisition is considered off-label, prevention services for IDUs target both injection and sexual risk behaviors, and therefore the CDC recommends the combination product.

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