TY - JOUR
T1 - Prevention of HIV-1 transmission through breastfeeding
T2 - 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
AU - Flynn, Patricia M.
AU - Taha, Taha E.
AU - Cababasay, Mae
AU - Fowler, Mary Glenn
AU - Mofenson, Lynne M.
AU - Owor, Maxensia
AU - Fiscus, Susan
AU - Stranix-Chibanda, Lynda
AU - Coutsoudis, Anna
AU - Gnanashanmugam, Devasena
AU - Chakhtoura, Nahida
AU - McCarthy, Katie
AU - Mukuzunga, Cornelius
AU - Makanani, Bonus
AU - Moodley, Dhayendre
AU - Nematadzira, Teacler
AU - Kusakara, Bangini
AU - Patil, Sandesh
AU - Vhembo, Tichaona
AU - Bobat, Raziya
AU - Mmbaga, Blandina T.
AU - Masenya, Maysseb
AU - Nyati, Mandisa
AU - Theron, Gerhard
AU - Mulenga, Helen
AU - Butler, Kevin
AU - Shapiro, David E.
N1 - Publisher Copyright:
Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2018
Y1 - 2018
N2 - Background: No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of motherto- 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 (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/mm3. 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.
AB - Background: No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of motherto- 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 (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/mm3. 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.
KW - Antiretroviral therapy (ART)
KW - Breastfeeding
KW - HIV-1
KW - Nevirapine
KW - Prevention of perinatal HIV-1 transmission
UR - http://www.scopus.com/inward/record.url?scp=85048572083&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85048572083&partnerID=8YFLogxK
U2 - 10.1097/QAI.0000000000001612
DO - 10.1097/QAI.0000000000001612
M3 - Article
C2 - 29239901
AN - SCOPUS:85048572083
SN - 1525-4135
VL - 77
SP - 383
EP - 392
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
IS - 4
ER -