In:
JAIDS Journal of Acquired Immune Deficiency Syndromes, Ovid Technologies (Wolters Kluwer Health), ( 2024-6-21)
Kurzfassung:
Safety data from randomized trials of antiretrovirals in pregnancy are scarce. We evaluated maternal bone and renal data from IMPAACT 2010 trial, which compared the safety and efficacy of three antiretroviral therapy regimens started in pregnancy: dolutegravir + emtricitabine/tenofovir alafenamide (DTG+FTC/TAF), dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+FTC/TDF), and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). Methods: A subset of participants underwent dual-energy X-ray absorptiometry (DXA) scans at postpartum week 50 only. Maternal bone mineral density (BMD) Z-scores were compared between arms. Maternal creatinine was measured at enrollment and periodically through week 50 postpartum and compared by-arm differences in average weekly change in estimated creatinine clearance (eCrCl). Results: 643 participants were randomized to DTG+FTC/TAF (N=217) or DTG+FTC/TDF (N=215) or EFV/FTC/TDF (N=211). Median age = 27 years (IQR 23, 32), median CD4 count = 466 cells/mm 3 (IQR 308, 624); 564 (88%) women enrolled in Africa and 479 (74%) breastfed. Week 50 postpartum DXA results from 154 women were included in the analysis. Hip and spine BMD was on average higher in women in the DTG+FTC/TAF and lower in the DTG+FTC/TDF and EFV/FTC/TDF arms, but no significant differences in BMD Z-scores were observed between treatment groups. The weekly rate of change in eCrCl differed among treatment groups during the antepartum period, but not over the full study follow-up. Conclusions: Markers of bone and renal toxicity did not differ significantly through week 50 postpartum among women randomized to start DTG+FTC/TAF or DTG+FTC/TDF or EFV/FTC/TDF in pregnancy.
Materialart:
Online-Ressource
ISSN:
1525-4135
DOI:
10.1097/QAI.0000000000003478
Sprache:
Englisch
Verlag:
Ovid Technologies (Wolters Kluwer Health)
Publikationsdatum:
2024
ZDB Id:
2038673-4