Clinicalinfo: Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection (update: june 2026)

Summary of Key Updates (June 25, 2026)

The Panel updated the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, with revisions focused on prevention, diagnosis, and treatment of HIV in infants and children.

Key changes include:

• Infant Feeding and Prevention

  • Breastfeeding is now considered an option, alongside formula or donor milk, if maternal ART is consistent and viral load is suppressed (<50 copies/mL for ≥3 months before delivery).
  • No evidence shows increased HIV risk with formula supplementation in this context.
  • Specific guidance is provided for breastfeeding management in cases of breast conditions (e.g., mastitis).

• Diagnosis of HIV in Infants and Children

  • Concerns about non-subtype B HIV-1 have been removed.
  • Testing schedules have been updated, with the final test recommended 3 months after stopping breastfeeding.
  • New, more sensitive HIV RNA assays are included.
  • Testing tables have been simplified.

• Initial Antiretroviral Therapy (ART)

  • Preferred regimen for neonates (≥2 kg, <30 days) is now dolutegravir (DTG) plus a ZDV-based backbone (ZDV + 3TC or FTC).
  • New dosing guidance for DTG dispersible tablets in neonates is included.
  • The “What Not to Start” section has been integrated into treatment recommendations.

• Management of HIV-Exposed Infants

  • Updated recommendations for three-drug presumptive treatment in high-risk infants (ZDV/3TC + NVP or DTG).
  • Birth HIV testing is recommended in most scenarios.
  • Extended prophylaxis during breastfeeding should continue until 4 weeks after last exposure or resolution of maternal viremia concerns.
  • Breastfeeding should be stopped if maternal viremia (≥200 copies/mL) occurs.

• Pediatric ARV Drug Information

  • Updated with new formulations, dosing, and safety data.
  • New approvals include darunavir/cobicistat formulations for children.
  • Some DTG- and ABC-based pediatric formulations are supported by the Panel despite not yet being FDA-approved.
  • Cobicistat standalone formulation has been discontinued.

Additional information to the following link: https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/whats-new