Safety and Efficacy of Starting Antiretroviral Therapy in the First Week of Life

Clin Infect Dis. 2021 Feb 1;72(3):388-393. doi: 10.1093/cid/ciaa028.


Background: Early antiretroviral therapy (ART) is recommended for infants with human immunodeficiency virus (HIV) infection. However, few antiretroviral options are available for neonates.

Methods: The Early Infant Treatment Study in Botswana tested HIV-exposed infants within 96 hours of birth, and HIV-infected infants started nevirapine (NVP) 6 mg/kg twice daily, zidovudine (ZDV), and lamivudine (3TC) at age < 7 days. NVP trough concentrations were tested at 1 and 2 weeks. NVP was switched to ritonavir-boosted lopinavir (LPV/r) at week 2, 3, 4, or 5 according to delivery gestational age.

Results: Forty HIV-infected infants started ART at median age 2 days (range, 1-5 days). NVP trough concentrations were highly variable and below therapeutic target (3000 ng/mL) for 50% of 2-week measurements; concentrations did not correlate with viral decline at weeks 2, 4, or 12. Two deaths unrelated to ART occurred through 24 weeks. Only 1 unscheduled treatment modification was required. Within 4 weeks of transition to LPV/r, 9 (22.5%) had transient HIV RNA increases, likely due to poor LPV/r palatability. At 12 weeks, 22 (55%) of 40 were <40 copies/mL (93% <400 copies/mL); by 24 weeks, 27 of 38 (71%) were < 40 copies/mL (84% < 400 copies/mL). HIV-1 RNA response at 12 and 24 weeks did not differ by baseline HIV RNA or other factors.

Conclusions: NVP/ZDV/3TC started in the first week of life was safe and effective, even when trough NVP levels were below target. Transient viral increases occurred following transition to LPV/r, but by 12 and 24 weeks most children achieved and maintained viral suppression.

Clinical trials registration: NCT02369406.

Keywords: Botswana; combination antiretroviral drugs; early infant treatment; efficacy; safety.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Anti-HIV Agents* / therapeutic use
  • Botswana
  • Child
  • Child, Preschool
  • HIV Infections* / drug therapy
  • Humans
  • Infant
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical
  • Lamivudine / therapeutic use
  • Nevirapine / adverse effects
  • Zidovudine / therapeutic use


  • Anti-HIV Agents
  • Lamivudine
  • Zidovudine
  • Nevirapine

Associated data