Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial.
Absorptiometry, Photon
Adult
Anti-HIV Agents
/ administration & dosage
Bone Density
/ drug effects
Breast Feeding
Drug Therapy, Combination
Emtricitabine
/ administration & dosage
Female
HIV Infections
/ drug therapy
Humans
Lopinavir
/ administration & dosage
Postpartum Period
/ drug effects
Ritonavir
/ administration & dosage
Tenofovir
/ administration & dosage
Young Adult
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2021
2021
Historique:
received:
25
05
2020
accepted:
09
01
2021
entrez:
5
2
2021
pubmed:
6
2
2021
medline:
28
7
2021
Statut:
epublish
Résumé
We set out to evaluate the effect of postnatal exposure to tenofovir-containing antiretroviral therapy on bone mineral density among breastfeeding women living with HIV. IMPAACT P1084s is a sub-study of the PROMISE randomized trial conducted in four African countries (ClinicalTrials.gov number NCT01066858). IMPAACT P1084s enrolled eligible mother-infant pairs previously randomised in the PROMISE trial at one week after delivery to receive either maternal antiretroviral therapy (Tenofovir disoproxil fumarate / Emtricitabine + Lopinavir/ritonavir-maternal TDF-ART) or administer infant nevirapine, with no maternal antiretroviral therapy, to prevent breastmilk HIV transmission. Maternal lumbar spine and hip bone mineral density were measured using dual-energy x-ray absorptiometry (DXA) at postpartum weeks 1 and 74. We studied the effect of the postpartum randomization on percent change in maternal bone mineral density in an intention-to-treat analysis with a t-test; mean and 95% confidence interval (95%CI) are presented. Among 398/400 women included in this analysis, baseline age, body-mass index, CD4 count, mean bone mineral density and alcohol use were comparable between study arms. On average, maternal lumbar spine bone mineral density declined significantly through week 74 in the maternal TDF-ART compared to the infant nevirapine arm; mean difference (95%CI) -2.86 (-4.03, -1.70) percentage points (p-value <0.001). Similarly, maternal hip bone mineral density declined significantly more through week 74 in the maternal TDF-ART compared to the infant nevirapine arm; mean difference -2.29% (-3.20, -1.39) (p-value <0.001). Adjusting for covariates did not change the treatment effect. Bone mineral density decline through week 74 postpartum was greater among breastfeeding HIV-infected women randomized to receive maternal TDF-ART during breastfeeding compared to those mothers whose infants received nevirapine prophylaxis.
Identifiants
pubmed: 33544759
doi: 10.1371/journal.pone.0246272
pii: PONE-D-20-15228
pmc: PMC7864465
doi:
Substances chimiques
Anti-HIV Agents
0
Lopinavir
2494G1JF75
Tenofovir
99YXE507IL
Emtricitabine
G70B4ETF4S
Ritonavir
O3J8G9O825
Banques de données
ClinicalTrials.gov
['NCT01066858']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0246272Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI068632
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 : UM1 AI068616
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069436
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 AI106716
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069436
Pays : United States
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
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