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

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dc.contributor.authorFlynn, Patricia M.
dc.contributor.authorTaha, Taha E.
dc.contributor.authorCababasay, Mae
dc.contributor.authorGlenn Fowler, Mary
dc.contributor.authorMofenson, Lynne M.
dc.contributor.authorOwor, Maxensia
dc.contributor.authorFiscus, Susan
dc.contributor.authorStranix-Chibanda, Lynda
dc.contributor.authorCoutsoudis, Anna
dc.contributor.authorGnanashanmugam, Devasena
dc.contributor.authorChakhtoura, Nahida
dc.contributor.authorMcCarthy, Katie
dc.contributor.authorMukuzunga, Cornelius
dc.contributor.authorMakanani, Bonus
dc.contributor.authorMoodley, Dhayendre
dc.contributor.authorNematadzira, Teacler
dc.contributor.authorKusakara, Bangini
dc.contributor.authorPatil, Sandesh
dc.contributor.authorVhembo, Tichaona
dc.contributor.authorBobat, Raziya
dc.contributor.authorMmbaga, Blandina T.
dc.contributor.authorMasenya, Maysseb
dc.contributor.authorNyati, Mandisa
dc.contributor.authorTheron, Gerhard
dc.contributor.authorMulenga, Helen
dc.contributor.authorButler, Kevin
dc.contributor.authorShapiro, David E.
dc.date.accessioned2022-03-08T11:20:00Z
dc.date.available2022-03-08T11:20:00Z
dc.date.issued2018
dc.description.abstractNo 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/mm3 (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 prophylaxis (iNVP) continued until 18 months post-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-October 2014, 2431 mother-infant pairs were enrolled; 97% of women were WHO Clinical Stage I, median screening CD4 count 686 cells/mm3. Median infant gestational age/birthweight were 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and seven of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio [HR] 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). Conclusion—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.en_US
dc.identifier.citationFlynn, P. M., Taha, T. E., Cababasay, M., Fowler, M. G., Mofenson, L. M., Owor, M., ... & PROMISE Study Team. (2018). 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. Journal of acquired immune deficiency syndromes (1999), 77(4), 383. doi:10.1097/QAI.0000000000001612.en_US
dc.identifier.other10.1097/QAI.0000000000001612.
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/2560
dc.language.isoenen_US
dc.publisherJournal of acquired immune deficiency syndromesen_US
dc.subjectBreastfeedingen_US
dc.subjectHIV-1en_US
dc.subjectPrevention of perinatal HIV-1 transmissionen_US
dc.subjectAntiretroviral therapy (ART)en_US
dc.subjectNevirapineen_US
dc.titlePrevention 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 trialen_US
dc.typeArticleen_US
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