TY - JOUR
T1 - Effects of preterm birth, maternal ART and breastfeeding on 24-month infant HIV-free survival in a randomized trial
AU - IMPAACT PROMISE 1077BF/FF team
AU - Dadabhai, Sufia
AU - Chou, Victoria B.
AU - Pinilla, Mauricio
AU - Chinula, Lameck
AU - Owor, Maxensia
AU - Violari, Avy
AU - Moodley, Dhayendre
AU - Stranix-Chibanda, Lynda
AU - Matubu, Taguma Allen
AU - Chareka, Gift Tafadzwa
AU - Theron, Gerhard
AU - Kinikar, Aarti Avinash
AU - Mubiana-Mbewe, Mwangelwa
AU - Fairlie, Lee
AU - Bobat, Raziya
AU - Mmbaga, Blandina Theophil
AU - Flynn, Patricia M.
AU - Taha, Taha E.
AU - Mccarthy, Katie S.
AU - Browning, Renee
AU - Mofenson, Lynne M.
AU - Brummel, Sean S.
AU - Fowler, Mary Glenn
N1 - Publisher Copyright:
© Copyright 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
PY - 2024/7/15
Y1 - 2024/7/15
N2 - Background: IMPAACT 1077BF/FF (PROMISE) compared the safety/efficacy of two HIV antiretroviral therapy (ART) regimens to zidovudine (ZDV) alone during pregnancy for HIV prevention. PROMISE found an increased risk of preterm delivery (<37 weeks) with antepartum triple ART (TDF/FTC/LPV+r or ZDV/3TC/LPV+r) compared with ZDV alone. We assessed the impact of preterm birth, breastfeeding, and antepartum ART regimen on 24-month infant survival. Methods: We compared HIV-free and overall survival at 24 months for liveborn infants by gestational age, time-varying breastfeeding status, and antepartum ART arm at 14 sites in Africa and India. Kaplan-Meier survival probabilities and Cox proportional hazards ratios were estimated. Results: Three thousand four hundred and eighty-two live-born infants [568 (16.3%) preterm and 2914 (83.7%) term] were included. Preterm birth was significantly associated with lower HIV-free survival [0.85; 95% confidence interval (CI) 0.82-0.88] and lower overall survival (0.89; 95% CI 0.86-0.91) versus term birth (0.96; 95% CI 0.95-0.96). Very preterm birth (<34 weeks) was associated with low HIV-free survival (0.65; 95% CI 0.54-0.73) and low overall survival (0.66; 95% CI 0.56-0.74). Risk of HIV infection or death at 24 months was higher with TDF-ART than ZDV-ART (adjusted hazard ratio 2.37; 95% CI 1.21-4.64). Breastfeeding initiated near birth decreased risk of infection or death at 24 months (adjusted hazard ratio 0.05; 95% CI 0.03-0.08) compared with not breastfeeding. Conclusion: Preterm birth and antepartum TDF-ART were associated with lower 24-month HIV-free survival compared with term birth and ZDV-ART. Any breastfeeding strongly promoted HIV-free survival, especially if initiated close to birth. Reducing preterm birth and promoting infant feeding with breastmilk among HIV/antiretroviral drug-exposed infants remain global health priorities.
AB - Background: IMPAACT 1077BF/FF (PROMISE) compared the safety/efficacy of two HIV antiretroviral therapy (ART) regimens to zidovudine (ZDV) alone during pregnancy for HIV prevention. PROMISE found an increased risk of preterm delivery (<37 weeks) with antepartum triple ART (TDF/FTC/LPV+r or ZDV/3TC/LPV+r) compared with ZDV alone. We assessed the impact of preterm birth, breastfeeding, and antepartum ART regimen on 24-month infant survival. Methods: We compared HIV-free and overall survival at 24 months for liveborn infants by gestational age, time-varying breastfeeding status, and antepartum ART arm at 14 sites in Africa and India. Kaplan-Meier survival probabilities and Cox proportional hazards ratios were estimated. Results: Three thousand four hundred and eighty-two live-born infants [568 (16.3%) preterm and 2914 (83.7%) term] were included. Preterm birth was significantly associated with lower HIV-free survival [0.85; 95% confidence interval (CI) 0.82-0.88] and lower overall survival (0.89; 95% CI 0.86-0.91) versus term birth (0.96; 95% CI 0.95-0.96). Very preterm birth (<34 weeks) was associated with low HIV-free survival (0.65; 95% CI 0.54-0.73) and low overall survival (0.66; 95% CI 0.56-0.74). Risk of HIV infection or death at 24 months was higher with TDF-ART than ZDV-ART (adjusted hazard ratio 2.37; 95% CI 1.21-4.64). Breastfeeding initiated near birth decreased risk of infection or death at 24 months (adjusted hazard ratio 0.05; 95% CI 0.03-0.08) compared with not breastfeeding. Conclusion: Preterm birth and antepartum TDF-ART were associated with lower 24-month HIV-free survival compared with term birth and ZDV-ART. Any breastfeeding strongly promoted HIV-free survival, especially if initiated close to birth. Reducing preterm birth and promoting infant feeding with breastmilk among HIV/antiretroviral drug-exposed infants remain global health priorities.
KW - HIV-exposed children
KW - antiretroviral drug exposures
KW - breastfeeding
KW - infant survival
KW - preterm birth
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UR - http://www.scopus.com/inward/citedby.url?scp=85197291344&partnerID=8YFLogxK
U2 - 10.1097/QAD.0000000000003878
DO - 10.1097/QAD.0000000000003878
M3 - Article
C2 - 38427596
AN - SCOPUS:85197291344
SN - 0269-9370
VL - 38
SP - 1304
EP - 1313
JO - AIDS
JF - AIDS
IS - 9
ER -