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Randomized Controlled Trial
. 2024 Jul 15;38(9):1304-1313.
doi: 10.1097/QAD.0000000000003878. Epub 2024 Mar 1.

Effects of preterm birth, maternal ART and breastfeeding on 24-month infant HIV-free survival in a randomized trial

Sufia Dadabhai  1   2 , Victoria B Chou  3 , Mauricio Pinilla  4 , Lameck Chinula  5   6 , Maxensia Owor  7 , Avy Violari  8 , Dhayendre Moodley  9 , Lynda Stranix-Chibanda  10   11 , Taguma Allen Matubu  12 , Gift Tafadzwa Chareka  13 , Gerhard Theron  12 , Aarti Avinash Kinikar  13 , Mwangelwa Mubiana-Mbewe  14 , Lee Fairlie  15 , Raziya Bobat  16 , Blandina Theophil Mmbaga  17 , Patricia M Flynn  18 , Taha E Taha  1 , Katie S McCarthy  19 , Renee Browning  20 , Lynne M Mofenson  21 , Sean S Brummel  4 , Mary Glenn Fowler  3 ; IMPAACT PROMISE 1077BF/FF team
Affiliations
Randomized Controlled Trial

Effects of preterm birth, maternal ART and breastfeeding on 24-month infant HIV-free survival in a randomized trial

Sufia Dadabhai et al. AIDS. .

Abstract

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.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Fig. 1
Fig. 1
Consort diagram for the PROMISE 24-month infant/child survival analyses.
Fig. 2
Fig. 2
Twenty-four-month HIV-free survival among PROMISE infants, by gestational age at birth.
See this image and copyright information in PMC

Comment in

References

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