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Breastfeeding Plus Infant Zidovudine Prophylaxis for 6 Months vs Formula Feeding Plus Infant Zidovudine for 1 Month to Reduce Mother-to-Child HIV Transmission in Botswana
A Randomized Trial: The Mashi Study
Ibou Thior, MD, MSc;
Shahin Lockman, MD, MSc;
Laura M. Smeaton, MSc;
Roger L. Shapiro, MD, MPH;
Carolyn Wester, MD;
S. Jody Heymann, MD, PhD;
Peter B. Gilbert, PhD;
Lisa Stevens, MD;
Trevor Peter, PhD, MPH;
Soyeon Kim, DSc;
Erik van Widenfelt, BSc;
Claire Moffat, MBChB, MPH;
Patrick Ndase, MBChB;
Peter Arimi, MBChB;
Poloko Kebaabetswe, PhD;
Patson Mazonde, MBChB;
Joseph Makhema, MBChB;
Kenneth McIntosh, MD;
Vladimir Novitsky, MD, PhD;
Tun-Hou Lee, DSc;
Richard Marlink, MD;
Stephen Lagakos, PhD;
Max Essex, DVM, PhD; for the Mashi Study Team
JAMA. 2006;296:794-805.
Context Postnatal transmission of human immunodeficiency virus-1 (HIV) via breastfeeding reverses gains achieved by perinatal antiretroviral interventions.
Objective To compare the efficacy and safety of 2 infant feeding strategies for the prevention of postnatal mother-to-child HIV transmission.
Design, Setting, and Patients A 2 x 2 factorial randomized clinical trial with peripartum (single-dose nevirapine vs placebo) and postpartum infant feeding (formula vs breastfeeding with infant zidovudine prophylaxis) interventions. In Botswana between March 27, 2001, and October 29, 2003, 1200 HIV-positive pregnant women were randomized from 4 district hospitals. Infants were evaluated at birth, monthly until age 7 months, at age 9 months, then every third month through age 18 months.
Intervention All of the mothers received zidovudine 300 mg orally twice daily from 34 weeks' gestation and during labor. Mothers and infants were randomized to receive single-dose nevirapine or placebo. Infants were randomized to 6 months of breastfeeding plus prophylactic infant zidovudine (breastfed plus zidovudine), or formula feeding plus 1 month of infant zidovudine (formula fed).
Main Outcome Measures Primary efficacy (HIV infection by age 7 months and HIV-free survival by age 18 months) and safety (occurrence of infant adverse events by 7 months of age) end points were evaluated in 1179 infants.
Results The 7-month HIV infection rates were 5.6% (32 infants in the formula-fed group) vs 9.0% (51 infants in the breastfed plus zidovudine group) (P = .04; 95% confidence interval for difference, –6.4% to –0.4%). Cumulative mortality or HIV infection rates at 18 months were 80 infants (13.9%, formula fed) vs 86 infants (15.1% breastfed plus zidovudine) (P = .60; 95% confidence interval for difference, –5.3% to 2.9%). Cumulative infant mortality at 7 months was significantly higher for the formula-fed group than for the breastfed plus zidovudine group (9.3% vs 4.9%; P = .003), but this difference diminished beyond month 7 such that the time-to-mortality distributions through age 18 months were not significantly different (P = .21).
Conclusions Breastfeeding with zidovudine prophylaxis was not as effective as formula feeding in preventing postnatal HIV transmission, but was associated with a lower mortality rate at 7 months. Both strategies had comparable HIV-free survival at 18 months. These results demonstrate the risk of formula feeding to infants in sub-Saharan Africa, and the need for studies of alternative strategies.
Trial Registration clinicaltrials.gov Identifier: NCT00197587
Author Affiliations: Department of Immunology and Infectious Diseases (Drs Thior, Lockman, Shapiro, Wester, Stevens, and Peter; Mr van Widenfelt; and Drs Makhema, Novitsky, Lee, Marlink, and Essex); Department of Biostatistics (Ms Smeaton, Drs Kim and Lagakos); and Department of Society, Human Development and Health (Dr Heymann), Harvard School of Public Health, Boston, Mass; Botswana–Harvard School of Public Health AIDS Initiative Partnership for HIV Research and Education, Bontleng, Gaborone, Botswana (Drs Thior, Lockman, Shapiro, Wester, Heymann, Stevens, Peter, and Kim; Mr. van Widenfelt; and Drs Moffat, Ndase, Arimi, Makhema, Novitsky, Marlink, and Essex); Infectious Disease Unit, Brigham and Women's Hospital, Boston, Mass (Dr Lockman); Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Mass (Dr Shapiro); Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle, Wash (Dr Gilbert); Botswana Ministry of Health, Gaborone, Botswana (Drs Kebaabetswe and Mazonde); and Division of Infectious Diseases, Children's Hospital, Boston, Mass (Dr McIntosh).
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