Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial

Author:

Masheto Gaerolwe12ORCID,Brummel Sean S.2,Ziemba Lauren2,Shepherd John3,Mbengeranwa Tapiwa4,Igawa Laarni3,Coletti Anne5,Mukura Dorinda4,Rossouw Lindie6,Theron Gerhard7,Krotje Chelsea8,Jean-Philippe Patrick9,Chakhtoura Nahida10,Cassim Haseena11,Mathiba Sisinyana Ruth11,Maena Joel12,Murtaugh William13,Fairlie Lee14,Currier Judith13,Hoffman Risa13,Chinula Lameck15,Sax Paul E.1617,Stranix-Chibanda Lynda418,Lockman Shahin121617,

Affiliation:

1. Botswana Harvard Health Partnership, Gaborone, Botswana;

2. Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, MA;

3. University of Hawai'i Cancer Center, Honolulu, HI;

4. University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe;

5. FHI 360, Durham, NC;

6. Family Centre for Research with Ubuntu (FAMCRU), Stellenbosch University, Cape Town, South Africa;

7. Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;

8. Frontier Science & Technology Research Foundation, Inc, Amherst, NY;

9. National Institute of Allergy and Infectious Diseases, Rockville, MD;

10. National Institute of Child Health and Human Development, Bethesda, MD;

11. Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa;

12. Makerere University–Johns Hopkins University Research Collaboration, Kampala, Uganda;

13. David Geffen School of Medicine, University of California, Los Angeles, CA;

14. Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;

15. UNC Project–Malawi, Lilongwe, Malawi;

16. Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA;

17. Harvard Medical School, Boston, MA; and

18. Child and Adolescent Health Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe.

Abstract

Background: Safety data from randomized trials of antiretrovirals in pregnancy are scarce. We evaluated maternal bone and renal data from the International Maternal Pediatric Adolescent AIDS Clinical Trials Network 2010 trial, which compared the safety and efficacy of 3 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 scans at postpartum week 50 only. Maternal bone mineral density (BMD) Z-scores were compared between arms. Maternal creatinine was measured at enrolment and periodically through week 50 postpartum, and by-arm differences in average weekly change in estimated creatinine clearance were compared. Results: Six hundred forty-three 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/mm3 (IQR 308, 624); 564 (88%) women enrolled in Africa and 479 (74%) breastfed. Week 50 postpartum dual-energy X-ray absorptiometry 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 estimated creatinine clearance 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.

Funder

National Institute of Allergy and Infectious Diseases

National Institute of Child Health and Human Development

Publisher

Ovid Technologies (Wolters Kluwer Health)

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3