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

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

Author Information

aDivision of Infectious Diseases, Beth Israel Deaconess Medical Center

bDepartment of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, Massachusetts, USA

cBotswana–Harvard AIDS Institute Partnership for HIV Research and Education, Gaborone, Botswana

dDepartment of Biostatistics, Harvard School of Public Health

eDepartment of Medicine, Division of Infectious Diseases, Brigham and Women's Hospital

fDepartments of Medicine and Pediatrics, Massachusetts General Hospital

gDivision of Infectious Diseases, Children's Hospital, Boston, Massachusetts

hNational Institutes of Health, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA

iUniversity of Botswana School of Medicine, Gaborone, Botswana.

Correspondence to Roger Shapiro, MD, MPH, Associate Professor of Medicine, Beth Israel Deaconess Medical Center, Division of Infectious Diseases, 110 Francis St, Suite GB, Boston, MA 02215, USA. Tel: +1 617 771 0040; fax: +1 617 632 0766; e-mail: rshapiro@hsph.harvard.edu

Received 29 January, 2013

Revised 11 March, 2013

Accepted 16 March, 2013

These data have been presented in part as: Shapiro RL, Kitch D, Hughes M, Ogwu, A, Lockman S, Souda S, Powis K, Moyo S, Makhema J, Essex M, and Mma Bana Study Team. Increased Maternal and Infant Mortality following Completion of HAART and Breastfeeding at 6 Months Postpartum in a Randomized PMTCT Trial: Botswana, the Mma Bana Study. 18th Conference on Retroviruses and Opportunistic Infections, Boston, Feb 27–Mar 2, 2011. Poster 747.

© 2013 Lippincott Williams & Wilkins, Inc.