PLoS ONE (Jan 2020)

The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.

  • Patience Atuhaire,
  • Sean S Brummel,
  • Blandina Theophil Mmbaga,
  • Konstantia Angelidou,
  • Lee Fairlie,
  • Avy Violari,
  • Gerhard Theron,
  • Cornelius Mukuzunga,
  • Sajeeda Mawlana,
  • Mwangelwa Mubiana-Mbewe,
  • Megeshinee Naidoo,
  • Bonus Makanani,
  • Patricia Mandima,
  • Teacler Nematadzira,
  • Nishi Suryavanshi,
  • Tapiwa Mbengeranwa,
  • Amy Loftis,
  • Michael Basar,
  • Katie McCarthy,
  • Judith S Currier,
  • Mary Glenn Fowler,
  • 1077BF/1077FF PROMISE Team

DOI
https://doi.org/10.1371/journal.pone.0228003
Journal volume & issue
Vol. 15, no. 1
p. e0228003

Abstract

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BackgroundGiven well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes.MethodsHIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis compared ART use limited to the antepartum period (AP-only) relative to women randomized to Zidovudine. The second analysis included women with no pregnancy combination ART exposure; and compared women randomized to either ART or no ART during postpartum (PP-only). Both analyses included follow-up time beyond breastfeeding period. The primary outcome was progression to AIDS and/or death. Secondary outcomes included adverse events and HIV-related events.Results3490 and 1137 HIV+ women were enrolled from 14 sites in Africa and India from April 2011 through September 2014 in cohort AP-only and PP-only, respectively. Most were Black African (96%); median age was 27 years; 97% were WHO Clinical Stage I; and most had a screening CD4 count ≥500 cells/mm3 (78%). The rate of progression to AIDS and/or death was similar and low across all comparison arms (AP comparison, HR = 1.14, 95%CI (0.44, 2.96), p-value = 0.79). In the PP-only cohort, the rate of WHO stage 2-3 events was lower for women randomized to ART(HR = 0.65, 95% CI 0.42, 1.01, p-value = 0.05).ConclusionThe incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms. This provides some reassurance that there were limited consequences for short term ART interruption in this group of asymptomatic HIV+ women during up to 4 years of follow up; and underscores that even short term ART exposure postpartum may reduce the risk of WHO grade 2-3 disease progression.