Updated HHS Pediatric Antiretroviral Therapy Guidelines Released

Date: April 8, 2021

The HHS Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV (the Panel) is pleased to announce the release of the updated Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

Key updates to the guidelines include the following:

  • In the section about Clinical and Laboratory Monitoring of Pediatric HIV Infection, the Panel has added content about the use of telemedicine visits and telehealth communication in the care of children with HIV, including information about the characteristics and requirements for in-person clinic visits vs. telemedicine visits.
  • Panel recommendations about initiating antiretroviral therapy in What to Start and treatment options in Management of Treatment Experienced Children have been updated based on recent Food and Drug Administration (FDA) approvals and new data. 
    • With the release of a new, dispersible tablet formulation of dolutegravir (DTG), DTG plus two nucleoside reverse transcriptase inhibitors (NRTIs) is now recommended as a Preferred antiretroviral (ARV) regimen for infants and young children (aged ≥4 weeks and weighing ≥3 kg) rather than being limited to children aged ≥3 years and weighing ≥25 kg. 
    • Bictegravir (BIC), which is available as a component of the fixed-dose combination (FDC) tablet bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy), is now recommended as a Preferred ARV regimen for children aged ≥6 years and weighing ≥25 kg.
    • The Panel now recommends raltegravir (RAL) plus 2 NRTIs as an Alternative integrase strand transfer inhibitor-based regimen for children aged ≥4weeks, rather than Preferred, because of its twice-daily dosing requirement and lower barrier to resistance compared to DTG or BIC. 
    • Although the FDA has approved abacavir (ABC) for use in infants aged ≥3 months, based on reassuring safety data, the Panel recommends ABC plus lamivudine or emtricitabine as a Preferred dual NRTI backbone for use in infants and children aged ≥1 month. 
    • With the ability to use ABC in infants and young children, zidovudine (ZDV) is now recommended as an Alternative NRTI for use in infants and children aged ≥1 month. 
  • Drug sections and Fixed-Dose Combination (FDC) Table 2 in Appendix A: Pediatric Antiretroviral Drug Information were reviewed and updated to include new FDA approvals; pediatric data, and dosing and safety information; plus new formulations and FDCs.

For a complete list of updates, please see What's New in the Guidelines. Additions and revisions are highlighted in yellow throughout the PDF version of the guidelines.

To view or download the guidelines, go to the Pediatric Guidelines section of Clinical Info’s website. The guideline tables and recommendations can also be downloaded as separate PDF files.

Clinical Info Welcomes Your Feedback

Feedback on the latest revisions to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection is welcome. Please send your comments with the subject line “Comments on the Pediatric Guidelines” to HIVinfo@NIH.gov by May 3, 2021.