TY - JOUR
T1 - The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes—A randomized clinical trial
AU - for the 1077BF/1077FF PROMISE Team
AU - Atuhaire, Patience
AU - Brummel, Sean S.
AU - Mmbaga, Blandina Theophil
AU - Angelidou, Konstantia
AU - Fairlie, Lee
AU - Violari, Avy
AU - Theron, Gerhard
AU - Mukuzunga, Cornelius
AU - Mawlana, Sajeeda
AU - Mubiana-Mbewe, Mwangelwa
AU - Naidoo, Megeshinee
AU - Makanani, Bonus
AU - Mandima, Patricia
AU - Nematadzira, Teacler
AU - Suryavanshi, Nishi
AU - Mbengeranwa, Tapiwa
AU - Loftis, Amy
AU - Basar, Michael
AU - McCarthy, Katie
AU - Currier, Judith S.
AU - Fowler, Mary Glenn
N1 - Publisher Copyright:
© 2020 Daly et al. This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - Background Given 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. Methods HIV+ 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. Results 3490 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). Conclusion The 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.
AB - Background Given 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. Methods HIV+ 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. Results 3490 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). Conclusion The 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.
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U2 - 10.1371/journal.pone.0228003
DO - 10.1371/journal.pone.0228003
M3 - Article
C2 - 31999753
AN - SCOPUS:85078710770
SN - 1932-6203
VL - 15
JO - PloS one
JF - PloS one
IS - 1
M1 - e0228003
ER -