Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial

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 NCT01...

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Published in:PloS one 2021-02, Vol.16 (2), p.e0246272-e0246272
Main Authors: Stranix-Chibanda, Lynda, Tierney, Camlin, Sebikari, Dorothy, Aizire, Jim, Dadabhai, Sufia, Zanga, Admire, Mukwasi-Kahari, Cynthia, Vhembo, Tichaona, Violari, Avy, Theron, Gerard, Moodley, Dhayandre, George, Kathleen, Fan, Bo, Sommer, Markus J, Browning, Renee, Mofenson, Lynne M, Shepherd, John, Nelson, Bryan, Fowler, Mary Glenn, Siberry, George K
Format: Article
Language:English
Subjects:
Acquired immune deficiency syndrome
AIDS
Alcohol use
Antiretroviral agents
Antiretroviral drugs
Antiretroviral therapy
Biology and Life Sciences
Biomedical materials
Bone density
Bone mineral density
Bone surgery
Bones
Breast
Breast feeding
Breastfeeding & lactation
Browning
Calcium
Calcium (dietary)
CD4 antigen
Cigarette smoking
Clinical trials
Complications and side effects
Data analysis
Density
Diet
Dietary intake
Disease transmission
Drug therapy
Editing
Emtricitabine
Epidemiology
Fractures
Health aspects
Health care
Health sciences
Highly active antiretroviral therapy
HIV
HIV infection
Human immunodeficiency virus
Hypersensitivity
Infants
Infections
Infectious diseases
Lopinavir
Medical imaging
Medicine
Medicine and Health Sciences
Nevirapine
Osteoporosis
Pediatrics
Physiological aspects
Population studies
Postpartum
Pregnancy
Prophylaxis
Protocol (computers)
Public health
Radiology
Research facilities
Reviews
Ritonavir
Tenofovir
Vitamin D
Websites
Womens health
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Summary: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
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0246272