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

Abstract

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/µl 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/µl 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/µl 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.

Trial registration: ClinicalTrials.gov NCT00270296.

Conflict of interest statement

No authors have a commercial or other association that might pose a conflict of interest (e.g., pharmaceutical stock ownership, consultancy, advisory board membership, relevant patents, or research funding).

Figures

Figure 1. Enrollment and Follow-up of Study Participants

* One woman had a live twin and a stillborn twin and was categorized as having a live delivery. One woman died 18 days after delivery of a stillborn, and one woman died 12 months after delivery of a stillborn.

Figure 2. Maternal Survival (A), Child Survival (B), Maternal HAART Status (C), and Child Breastfeeding Status (D), by Study Arm*

* Note: the range for the vertical axis is 0.9–1.0 in panels A and B, and 0–1.0 in panels C and D.