Pediatric HIV guidelines elevate dolutegravir, update breastfeeding management

Clinical takeaway: For full-term neonates weighing ≥2 kg, dolutegravir-based therapy is now the preferred initial antiretroviral regimen, while updated recommendations also expand guidance on breastfeeding, infant prophylaxis, and HIV diagnostic testing.

The Department of Health and Human Services (DHHS) has released a significant update to its Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, reflecting new evidence on antiretroviral therapy (ART), infant feeding, HIV diagnosis, and management of infants exposed to HIV.

“Beginning in 2026, the Panel will highlight key evidence gaps in individual guideline sections with a goal of motivating research that can close those gaps and improve the quality and impact of recommendations developed for children affected by HIV,” the guideline authors noted.

What’s changed

• Preferred initial ART for neonates now includes dolutegravir (DTG) plus zidovudine (ZDV) and either lamivudine (3TC) or emtricitabine (FTC) for full-term infants from birth to <30 days of age who weigh ≥2 kg.
• New neonatal dosing guidance supports use of DTG dispersible tablets (Tivicay PD), and the panel also supports use of ABC/DTG/3TC dispersible tablets (Triumeq PD) in eligible children, although these strategies are not yet FDA-approved.
• For infants at high risk of HIV acquisition, recommended 3-drug presumptive therapy now consists of ZDV/3TC plus either nevirapine (NVP) or DTG.
• Birth HIV nucleic acid testing is now recommended in nearly all exposed infants, except those considered low risk.
• Diagnostic testing recommendations for breastfed infants were revised; testing should continue during breastfeeding and include a final virologic test 3 months after breastfeeding ends.
• Guidance on infant feeding was updated to support counseling on breastfeeding, formula feeding, or donor milk when a parent has maintained viral suppression (<50 copies/mL) for at least 3 months before delivery.
• New recommendations address management of maternal viremia during breastfeeding, including cessation of breastfeeding when HIV RNA reaches ≥200 copies/mL or when significant concerns about adherence arise.
• Pediatric antiretroviral drug tables were updated with new dosing, safety, formulation, and FDA approval information, including approval of darunavir/cobicistat oral suspension tablets (Prezcobix PED) for certain children aged ≥3 years.

The updated guidance continues to emphasize integrase strand transfer inhibitor (INSTI)-based therapy across pediatric age groups. The panel also reinforced optimization of treatment regimens toward INSTI-based combinations in children and adolescents with sustained virologic suppression because of their favorable efficacy and safety profiles.

Additional updates include expanded recommendations for extended infant prophylaxis during breastfeeding and updated strategies for managing treatment failure, including use of regimens containing at least one agent with a high resistance barrier, such as a second-generation INSTI or boosted protease inhibitor.

The guideline also highlights the unique challenges faced by adolescents with perinatally acquired HIV, noting that suboptimal care may reduce life expectancy by an estimated 10 to 12 years compared with peers without HIV.

Overall, the update further shifts pediatric HIV management toward earlier use of potent INSTI-based regimens, individualized infant feeding counseling, and intensified monitoring of HIV-exposed infants, particularly during and after breastfeeding.

Source: Panel on Antiretroviral Therapy and Medical Management of Children Living With HIV. (2026 June 25) Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection