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Issue No. 8 | April 14, 2020

News and Features

HHS Pediatric Antiretroviral Treatment Guidelines Updated

The Department of Health and Human Services (HHS) Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV (the Panel) has released an updated version of the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

The key updates to the guidelines include: 

  • In When to Initiate Therapy in Antiretroviral-Naive Children, the Panel now recommends rapid initiation of antiretroviral therapy (ART) for all children, not just those aged <1 year. Rapid initiation is defined as initiating therapy immediately or within days of HIV diagnosis. Because the Panel no longer makes recommendations about when to initiate ART based on a child’s age (either <1 year of age or ≥1 year of age), Table A has been deleted and the data that support rapid initiation have been grouped by outcome. The Panel acknowledges that, on a case-by-case basis, initiation of ART may be deferred based on a patient’s clinical or psychosocial factors. The Panel highlights medical factors, including HIV signs and symptoms, that should be considered when clinicians, patients, and caregivers make collaborative decisions about whether to defer treatment.
  • The text and Table 7 in What to Start: Regimens Recommended for Initial Therapy of Antiretroviral-Naive Children have been updated following Food and Drug Administration (FDA) approval of cobicistat (COBI) for pediatric use. The Panel also now recommends atazanavir (ATV) boosted with COBI (ATV/c) or darunavir (DRV) boosted with COBI (DRV/c) plus two nucleoside reverse transcriptase inhibitors as Alternative protease inhibitor-based initial regimens for children and adolescents aged ≥12 years with a sexual maturity rating of 1 to 3 who weigh ≥35 kg or ≥40 kg, respectively.
  • Throughout the guidelines, the Panel refers to the Adult and Adolescent Antiretroviral Guidelines and the Perinatal Guidelines for guidance about the use of dolutegravir and other antiretroviral (ARV) drugs in people of childbearing potential and those who are pregnant or who are trying to conceive.
  • The Panel has changed the term “empiric HIV therapy” to “presumptive HIV therapy” in Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection and throughout the guidelines to be consistent with the terminology used by the World Health Organization. The Panel recommends presumptive HIV therapy for infants who are at a higher risk of perinatal HIV acquisition.
  • Table 11 and Table 12 have been revised to clarify the ARV regimens and the duration and dosing of ARV drugs that are used for presumptive HIV therapy. The two-drug regimen that was used in NICHD-HPTN 040/PACTG 1043 for infants who were at a higher risk of HIV acquisition is no longer included in Tables 11 and 12; this regimen is described in the text instead.
  • The Panel added a new subsection to Special Considerations for Antiretroviral Therapy Use in Adolescents with HIV entitled Special Considerations for Adolescents with HIV Who Are Sexual Minorities.
  • Table 15a includes updated information about neuropsychiatric symptoms and other central nervous system manifestations that are associated with the use of integrase strand transfer inhibitors. Information on bictegravir has also been added to the table. Information about the association between ARV drugs and weight gain has been added to Table 15h, and the table has been renamed Antiretroviral Therapy-Associated Adverse Effects and Management Recommendations—Lipodystrophies and Weight Gain.
  • The drug sections and Appendix A, Table 2 were updated to include new pediatric data and dosing and safety information, plus new drug formulations and fixed-dose combination (FDC) drugs. Raltegravir (RAL) HD is now recommended for use in children and adolescents weighing ≥40 kg who are treatment naive or who are virologically suppressed on an initial dose of RAL 400 mg twice daily. Although lopinavir/ritonavir is not approved by the FDA for use in neonates before a postmenstrual age of 42 weeks and a postnatal age of at least 14 days, the Panel now provides some guidance for situations where no alternatives are available for neonates who have not met these age thresholds.
  • The ATV, DRV, and COBI drug sections have been updated to reflect recent FDA approvals and updated Panel recommendations. COBI (Tybost) is now approved by the FDA for use with ATV in children and adolescents weighing ≥35 kg and for use with DRV in children and adolescents weighing ≥40 kg. The FDC tablet DRV/c/emtricitabine/tenofovir alafenamide (Symtuza) is now approved by the FDA for use in children and adolescents weighing ≥40 kg. Although coformulated ATV/c (Evotaz) and DRV/c (Prezcobix) are not approved by the FDA for use in children, the Panel does recommend using these FDC tablets in pediatric patients weighing ≥35 kg or ≥40 kg, respectively, based on FDA approvals of the individual component drugs.

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.

AIDSinfo 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 ARV Guidelines” to by April 28, 2020.