Antiretroviral Regimens in Pregnancy and Breast-Feeding in Botswana

N Engl J Med. 2010 Jun 17;362(24):2282-94. doi: 10.1056/NEJMoa0907736.

Abstract

Background: The most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown.

Methods: We randomly assigned 560 HIV-1-infected pregnant women (CD4+ count, > or = 200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir-ritonavir plus zidovudine-lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine.

Results: The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI group, 93% in the protease-inhibitor group, and 94% in the observational group) or throughout the breast-feeding period (92% in the NRTI group, 93% in the protease-inhibitor group, and 95% in the observational group). By 6 months of age, 8 of 709 live-born infants (1.1%) were infected (95% confidence interval [CI], 0.5 to 2.2): 6 were infected in utero (4 in the NRTI group, 1 in the protease-inhibitor group, and 1 in the observational group), and 2 were infected during the breast-feeding period (in the NRTI group). Treatment-limiting adverse events occurred in 2% of women in the NRTI group, 2% of women in the protease-inhibitor group, and 11% of women in the observational group.

Conclusions: All regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%. (ClinicalTrials.gov number, NCT00270296.)

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Antiretroviral Therapy, Highly Active* / adverse effects
  • Breast Feeding*
  • CD4 Lymphocyte Count
  • Female
  • Follow-Up Studies
  • HIV Infections / drug therapy
  • HIV Infections / transmission*
  • HIV Protease Inhibitors / therapeutic use
  • HIV-1* / genetics
  • HIV-1* / isolation & purification
  • Humans
  • Infant
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Male
  • Neutropenia / chemically induced
  • Nevirapine / therapeutic use
  • Patient Compliance
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy*
  • RNA, Viral / blood
  • Risk Factors
  • Viral Load / drug effects
  • Young Adult
  • Zidovudine / therapeutic use

Substances

  • HIV Protease Inhibitors
  • RNA, Viral
  • Zidovudine
  • Nevirapine

Associated data

  • ClinicalTrials.gov/NCT00270296