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Randomized Controlled Trial
. 2018 Apr 1;77(4):383-392.
doi: 10.1097/QAI.0000000000001612.

Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomized, Open-Label, Clinical Trial

Patricia M Flynn  1 , Taha E Taha  2 , Mae Cababasay  3 , Mary Glenn Fowler  4 , Lynne M Mofenson  5 , Maxensia Owor  6 , Susan Fiscus  7 , Lynda Stranix-Chibanda  8 , Anna Coutsoudis  9 , Devasena Gnanashanmugam  10 , Nahida Chakhtoura  11 , Katie McCarthy  12 , Cornelius Mukuzunga  13 , Bonus Makanani  14 , Dhayendre Moodley  15 , Teacler Nematadzira  16 , Bangini Kusakara  16 , Sandesh Patil  17 , Tichaona Vhembo  16 , Raziya Bobat  18 , Blandina T Mmbaga  19 , Maysseb Masenya  20 , Mandisa Nyati  21 , Gerhard Theron  22 , Helen Mulenga  23 , Kevin Butler  3 , David E Shapiro  3 ; PROMISE Study Team
Affiliations
Randomized Controlled Trial

Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomized, Open-Label, Clinical Trial

Patricia M Flynn et al. J Acquir Immune Defic Syndr. .

Abstract

Background: No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period.

Setting: Fourteen sites in Sub-Saharan Africa and India.

Methods: A randomized, open-label strategy trial was conducted in HIV-1-infected women with CD4 counts ≥350 cells/mm (or ≥country-specific ART threshold if higher) and their breastfeeding HIV-1-uninfected newborns. Randomization at 6-14 days postpartum was to mART or infant nevirapine (iNVP) prophylaxis continued until 18 months after delivery or breastfeeding cessation, infant HIV-1 infection, or toxicity, whichever occurred first. The primary efficacy outcome was confirmed infant HIV-1 infection. Efficacy analyses included all randomized mother-infant pairs except those with infant HIV-1 infection at entry.

Results: Between June 2011 and October 2014, 2431 mother-infant pairs were enrolled; 97% of women were World Health Organization Clinical Stage I, median screening CD4 count 686 cells/mm. Median infant gestational age/birth weight was 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and 7 of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio 1.0, 96% repeated confidence interval 0.3-3.1); infant HIV-free survival was high (97.1%, mART and 97.7%, iNVP, at 24 months). There were no significant differences between arms in median time to breastfeeding cessation (16 months) or incidence of severe, life-threatening, or fatal adverse events for mothers or infants (14 and 42 per 100 person-years, respectively).

Conclusions: Both mART and iNVP prophylaxis strategies were safe and associated with very low breastfeeding HIV-1 transmission and high infant HIV-1-free survival at 24 months.

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Conflict of interest statement

Conflict of Interest: Dr. Flynn is a consultant for Merck. No other authors declare conflict of interest.

Figures

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References

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    1. Van de Perre P, Kankasa C, Nagot N, et al. Pre-exposure prophylaxis for infants exposed to HIV through breastfeeding. BMJ. 2017;356:j1053. - PubMed

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