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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.
JAMA 2006; 296(7):794-805JAMA

Abstract

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.

Authors+Show Affiliations

Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, Mass 02115, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16905785

Citation

Thior, Ibou, et al. "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." JAMA, vol. 296, no. 7, 2006, pp. 794-805.
Thior I, Lockman S, Smeaton LM, et al. 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. JAMA. 2006;296(7):794-805.
Thior, I., Lockman, S., Smeaton, L. M., Shapiro, R. L., Wester, C., Heymann, S. J., ... Essex, M. (2006). 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. JAMA, 296(7), pp. 794-805.
Thior I, et al. 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. JAMA. 2006 Aug 16;296(7):794-805. PubMed PMID: 16905785.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Thior,Ibou, AU - Lockman,Shahin, AU - Smeaton,Laura M, AU - Shapiro,Roger L, AU - Wester,Carolyn, AU - Heymann,S Jody, AU - Gilbert,Peter B, AU - Stevens,Lisa, AU - Peter,Trevor, AU - Kim,Soyeon, AU - van Widenfelt,Erik, AU - Moffat,Claire, AU - Ndase,Patrick, AU - Arimi,Peter, AU - Kebaabetswe,Poloko, AU - Mazonde,Patson, AU - Makhema,Joseph, AU - McIntosh,Kenneth, AU - Novitsky,Vladimir, AU - Lee,Tun-Hou, AU - Marlink,Richard, AU - Lagakos,Stephen, AU - Essex,Max, AU - ,, PY - 2006/8/15/pubmed PY - 2006/8/19/medline PY - 2006/8/15/entrez SP - 794 EP - 805 JF - JAMA JO - JAMA VL - 296 IS - 7 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/16905785/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_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.296.7.794 DB - PRIME DP - Unbound Medicine ER -