The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2020
2020
Historique:
received:
20
09
2019
accepted:
03
01
2020
entrez:
31
1
2020
pubmed:
31
1
2020
medline:
15
4
2020
Statut:
epublish
Résumé
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. 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. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 31999753
doi: 10.1371/journal.pone.0228003
pii: PONE-D-19-25671
pmc: PMC6992010
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0228003Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI069423
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069424
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068632
Pays : United States
Organisme : NIMH NIH HHS
ID : R21 MH083308
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069518
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069453
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069424
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI106716
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069469
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069530
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069463
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068616
Pays : United States
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):31-7
pubmed: 26334739
N Engl J Med. 2015 Aug 27;373(9):795-807
pubmed: 26192873
J Acquir Immune Defic Syndr. 2018 Apr 1;77(4):383-392
pubmed: 29239901
N Engl J Med. 2006 Nov 30;355(22):2283-96
pubmed: 17135583
Lancet HIV. 2015 Nov;2(11):e464-73
pubmed: 26520926
HIV Clin Trials. 2018 Dec;19(6):209-224
pubmed: 30890061
J Acquir Immune Defic Syndr. 2017 Jan 1;74(1):38-43
pubmed: 27787340
PLoS One. 2017 May 10;12(5):e0176009
pubmed: 28489856
N Engl J Med. 2016 Nov 3;375(18):1726-1737
pubmed: 27806243
AIDS. 2012 Oct 23;26(16):2039-52
pubmed: 22951634