The Panel on Antiretroviral Therapy and Medical Management of Children Living With HIV has reviewed and updated the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, including three sections developed in collaboration with the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. 

Preventing HIV Transmission During Infant Feeding  

• If antiretroviral therapy (ART) is taken consistently and the viral load is maintained at a level of <50 copies/mL (i.e., undetectable viral load) for at least three months prior to delivery, the Panels recommend counseling about the options of formula feeding, use of banked donor milk, or breastfeeding. 

Diagnosis of HIV Infection in Infants and Children  

• The Panels revised the recommended timing of virologic diagnostic testing for infants with perinatal HIV exposure who are being breastfed. The last test should be performed three months after cessation of breastfeeding and at least two weeks after completion of infant antiretroviral prophylaxis.  

What to Start: Antiretroviral Treatment Regimens Recommended for Initial Therapy in Infants and Children With HIV 

• The preferred regimen for initial ART in full-term infants from birth to age <30 days who weigh ≥2 kg is now the second-generation integrase inhibitor dolutegravir (DTG) in combination with a nucleoside reverse transcriptase inhibitor backbone of zidovudine (ZDV) plus either lamivudine (3TC) or emtricitabine (FTC). 

• Studies have established dosing guidelines for DTG pediatric dispersible tablets in neonates.  

Antiretroviral Management of Infants With In Utero, Intrapartum or Breastfeeding Exposure to HIV Infection  

• Three-drug presumptive treatment for infants with high risk of HIV acquisition now consists of ZDV/3TC plus nevirapine (NVP) or DTG.  

• The Panel recommends that extended ARV prophylaxis during breastfeeding, when used, be continued until either four weeks after the last exposure to breast milk or four weeks after concerns about maternal virologic suppression have resolved (BIII).  

• If a maternal HIV RNA level of ≥200 copies/mL (viremia) develops or there is presumed viremia (e.g., reports of nonadherence to ARVs) during breastfeeding, the Panels recommend cessation of breastfeeding. If the infant was not receiving ARV prophylaxis, a three-drug ARV regimen should be given for four weeks. If the infant was receiving ARV prophylaxis with 3TC or NVP, the decision to either continue the single-drug prophylaxis or initiate treatment with a three-drug regimen should be based on maternal RNA level and other factors (AII). 

Appendix A: Pediatric Antiretroviral Drug Information  

• The FDA approved use of darunavir and cobicistat (Prezcobix PED) tablets for oral suspension for children aged ≥3 years and weighing ≥15 kg to <25 kg for use in combination with other ARV drugs (see Cobicistat).