CDC PrEP Guidelines

Among patients who have taken oral PrEP or have received injectable PrEP, the addition of qualitative or quantitative HIV-1 RNA to HIV antibody/antigen testing is recommended to optimize the determination of HIV status. In recent clinical trials of injectable PrEP, it was found that PrEP drugs may delay the timing of antibody development, and thus additional testing is required to confirm HIV status.2 Therefore, updated CDC guidance incorporates HIV-1 RNA testing at specified time points to increase the likelihood of detecting acute infection and facilitate the timely transition from PrEP to antiretroviral therapy where necessary.3

Labcorp’s CDC-compliant PrEP panels

  Sex Assigned at Birth PrEP Type Test No. Test Name HIV RNA* HIV Ag/Ab Syphilis CT/NG
(Urine)
HCV HBV eGFR β-hCG
Initiate PrEP (Baseline) Male Oral 254842 PrEP, Male, Oral Baseline + HIV RNA X X X X X X X  
Injectable 254972 PrEP, Male, Injectable Baseline + HIV RNA X X X X X X    
Female Oral 254855 PrEP, Female, Oral Baseline + HIV RNA X X X X X X X X
Injectable 254988 PrEP, Female, Injectable Baseline + HIV RNA X X X X X X   X
Manage PrEP (Monitor) Male

Oral

254868 PrEP, Male, Oral Monitor + HIV RNA X X X X        
Injectable 254736 PrEP, Male, Injectable Monitor + HIV RNA X X X X        
Female Oral 254880 PrEP, Female, Oral Monitor + HIV RNA X X X X       X
Injectable 254801 PrEP, Female, Injectable Monitor + HIV RNA X X X X       X

Legacy Panels without the recommended HIV RNA

  Sex Assigned at Birth PrEP Type Test No. Test Name HIV RNA* HIV Ag/Ab Syphilis CT/NG
(Urine)
HCV HBV eGFR β-hCG

Manage PrEP (Monitor) without HIV RNA

(Optional)

Male Oral 254892 PrEP, Male, Oral Monitor (No HIV RNA) X X X X        
Injectable 254937 PrEP, Male, Injectable Monitor (No HIV RNA) X X X X        
Female Oral 254905 PrEP, Female, Oral Monitor (No HIV RNA) X X X X       X
Injectable 254951 PrEP, Male, Injectable Monitor (No HIV RNA) X X X X       X

 

 

 

Additional PrEP-Related Testing

 

PrEP Guidelines by the CDC

For Oral PrEP Testing

  • Prior to initiation (Baseline Panel)
  • Every 3 months (Monitor Panel)
  • Renal function testing at baseline and every 6 months for patients taking oral TDF/FTC, >50 years of age or eCrCL <90
  • Lipid evaluation in persons taking FTC/TAF

For Injectable PrEP Testing

  • Prior to initiation (Baseline Panel)
  • 1 month follow up (Monitor Panel)
  • Every 2 months (Monitor Panel)

PrEP Insurance Coverage

Out of pocket costs can be a burden to preventive care. PrEP services received a Grade A recommendation from the United States Preventive Services Task Force (USPSTF). This means for commercial health insurances and Medicaid expansion programs, the Affordable Care Act requires PrEP services to be covered with no cost sharing before any deductible and without coinsurance or copayment*.4

When you order Labcorp's CDC-compliant PrEP panels, we will bill the tests in accordance with the no cost-sharing policy set forth by the Affordable Care Act, which can help minimize your patients' out-of-pocket costs.

 

References:

  1. US Public Health Service; Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 A clinical practice guideline. Available at https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed December 22, 2022.
  2. Marzinke MA, Grinsztejn B, Fogel JM, et al. Characterization of human immunodeficiency virus (HIV) infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. Infect Ds. 2021;
  3. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States-2021 Update Clinical Practice Guideline, US Public Health Service and the Centers for Disease Control
  4. National Alliance of State & Territorial AIDS Directors (NASTAD). NASTAD PrEP Coverage Brief: PrEP Services Covered with No Cost-Sharing. https://nastad.org/sites/default/files/2021-11/PDF-NASTAD-PrEP-Coverage-Brief.pdf. Accessed December 22, 2022.