Effects of Preterm Birth, Maternal ART and Breastfeeding on 24-month Infant HIV-free Survival in a Randomized Trial

Overview

Journal AIDS

Specialty Infectious Diseases

Date 2024 Mar 1

PMID 38427596

Authors

Sufia Dadabhai

Victoria B Chou

Mauricio Pinilla

Lameck Chinula

Maxensia Owor

Avy Violari

Dhayendre Moodley

Lynda Stranix-Chibanda

Taguma Allen Matubu

Gift Tafadzwa Chareka

Gerhard Theron

Aarti Avinash Kinikar

Mwangelwa Mubiana-Mbewe

Lee Fairlie

Raziya Bobat

Blandina Theophil Mmbaga

Patricia M Flynn

Taha E Taha

Katie S McCarthy

Renee Browning

Lynne M Mofenson

Sean S Brummel

Mary Glenn Fowler

Affiliations

Soon will be listed here.

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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