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AIDS:
doi: 10.1097/QAD.0b013e32836158b0
Clinical Science

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

Shapiro, Roger L.a,b,c; Kitch, Douglasd; Ogwu, Anthonyc; Hughes, Michael D.d; Lockman, Shahinb,c,e; Powis, Kathleenb,c,f; Souda, Sajinic; Moffat, Clairec; Moyo, Sikhulilec; McIntosh, Kennethg; van Widenfelt, Erikc; Zwerski, Sherylh; Mazhani, Loetoi; Makhema, Josephb,c; Essex, Maxb,c

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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.

© 2013 Lippincott Williams & Wilkins, Inc.

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