HIV transmission and 24-month survival in a randomized trial of HAART to prevent MTCT during pregnancy and breastfeeding in Botswana

Objectives: HAART for prevention of mother-to-child HIV transmission (MTCT) may impact long-term survival of women and children. Design: Randomized clinical trial. Methods: HIV-infected pregnant women with CD4(+) cell count at least 200 cells/mu l were randomly assigned to abacavir, zidovudine, lamivudine (arm A) or lopinavir-ritonavir, zidovudine-lamivudine (arm B) from week 26 to 34 gestation through planned weaning by 6 months postpartum. Women with baseline CD4(+) cell count less than 200 cells/mu l received nevirapine-zidovudine-lamivudine indefinitely (Obs arm), as did randomized women later qualifying for treatment. Results: Among 560 randomized and 170 observational women enrolled, there were 14 deaths (1.9%) - one antenatally (Obs), three from delivery to 6 months postpartum (1 arm A, 2 Obs), and 10 from 6 to 24 months postpartum (5 arm A, 3 arm B, 2 Obs). Time to death or CD4(+) cell count below 200 cells/mu l was shorter in arm A vs. B (P=0.03). Of the 709 live-born children, 97% breastfed for a median of 5.8 months. Of 37 (5.2%) deaths by 24 months, nine were before breastfeeding initiated (3 arm A, 2 arm B, 4 Obs); six while breastfeeding (1 arm A, 2 arm B, 3 Obs); and 22 after weaning (9 arm A, 11 arm B, 2 Obs). Only eight children (1.1%) were HIV-infected at 24 months (6 arm A, 1 arm B, 1 Obs), all before 6 months. Conclusion: Low MTCT was maintained through extended follow-up in all arms. Disease progression appeared slower after discontinuing protease inhibitor-based HAART, but a concerning number of maternal deaths occurred after stopping either regimen. Strategies to improve maternal and child survival in the postintervention period are required. (C) 2013 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins