The Department of Health and Human Services (HHS) Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV (the Panel) revised several sections of the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection to update content and recommendations about the use of the antiretroviral drugs bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) and dolutegravir in children and adolescents. The updates are summarized below.
- Table 7. Antiretroviral Regimens Recommended for Initial Therapy for HIV Infection in Children, Figure 1, and the associated text now include new recommendations for the use of bictegravir and dolutegravir in children:
- The fixed-dose combination (FDC) tablet Biktarvy is now a Preferred integrase strand transfer inhibitor (INSTI)-based regimen for adolescents aged ≥12 years and weighing ≥25 kg (AI) and an Alternative INSTI-based regimen for children aged ≥6 years and weighing ≥25 kg (AI).
- Dolutegravir plus two nucleoside reverse transcriptase inhibitors is now an Alternative INSTI-based regimen for children aged ≥3 years and weighing ≥20 kg to <25 kg (AI*). It was previously recommended only for children weighing ≥25 kg. Data are limited on the efficacy and safety of administering dolutegravir to children weighing ≥20 kg to <25 kg and dolutegravir pharmacokinetics vary more among children in this weight group than among those weighing ≥25 kg.
- Table 8. Advantages and Disadvantages of Antiretroviral Components Recommended for Initial Therapy in Children now includes information about Biktarvy.
- Bictegravir was removed from this section following Food and Drug Administration (FDA) approval for the use of Biktarvy in children and adolescents weighing ≥25 kg.
- Table 16. Examples of Changes in Antiretroviral Regimen Components for Children with Sustained Virologic Suppression has been updated to reflect revised recommendations for the use of bictegravir and dolutegravir.
- Certain drug sections and Tables 1 and 2 were updated to include new pediatric data and dosing information for bictegravir and dolutegravir, including a new FDC tablet.
- Bictegravir, which is available only in the FDC tablet Biktarvy, is now approved by the FDA for use in children and adolescents weighing ≥25 kg.
- Based on recent data, the dosing recommendations for dolutegravir have been revised to allow use in children weighing ≥20 kg, although dolutegravir is not approved by the FDA for use in children weighing <30 kg. A new table in this section compares FDA, European Medicines Agency (EMA), World Health Organization (WHO), and Panel dosing recommendations for dolutegravir. Dolutegravir/lamivudine (Dovato), a new FDC tablet that has been approved for use in adults, was added to the Dolutegravir and Lamivudine sections and to Tables 1 and 2.
- The Emtricitabine and Tenofovir Alafenamide sections have been updated to reflect changes in the dosing recommendations for FDC tablets that contain bictegravir or dolutegravir.
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 ARV Guidelines section of AIDSinfo’s website. The guideline tables and recommendations can also be downloaded as separate PDF files.