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Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial.
Masheto, Gaerolwe; Brummel, Sean S; Ziemba, Lauren; Shepherd, John; Mbengeranwa, Tapiwa; Igawa, Laarni; Coletti, Anne; Mukura, Dorinda; Rossouw, Lindie; Theron, Gerhard; Krotje, Chelsea; Jean-Philippe, Patrick; Chakhtoura, Nahida; Cassim, Haseena; Mathiba, Sisinyana Ruth; Maena, Joel; Murtaugh, William; Fairlie, Lee; Currier, Judith; Hoffman, Risa; Chinula, Lameck; Sax, Paul E; Stranix-Chibanda, Lynda; Lockman, Shahin.
Afiliación
  • Masheto G; Botswana Harvard Health Partnership, Gaborone, Botswana.
  • Brummel SS; Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, MA.
  • Ziemba L; Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, MA.
  • Shepherd J; Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, MA.
  • Mbengeranwa T; University of Hawai'i Cancer Center, Honolulu, HI.
  • Igawa L; University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.
  • Coletti A; University of Hawai'i Cancer Center, Honolulu, HI.
  • Mukura D; FHI 360, Durham, NC.
  • Rossouw L; University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.
  • Theron G; Family Centre for Research with Ubuntu (FAMCRU), Stellenbosch University, Cape Town, South Africa.
  • Krotje C; Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
  • Jean-Philippe P; Frontier Science & Technology Research Foundation, Inc, Amherst, NY.
  • Chakhtoura N; National Institute of Allergy and Infectious Diseases, Rockville, MD.
  • Cassim H; National Institute of Child Health and Human Development, Bethesda, MD.
  • Mathiba SR; Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
  • Maena J; Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
  • Murtaugh W; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
  • Fairlie L; David Geffen School of Medicine, University of California, Los Angeles, CA.
  • Currier J; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Hoffman R; David Geffen School of Medicine, University of California, Los Angeles, CA.
  • Chinula L; David Geffen School of Medicine, University of California, Los Angeles, CA.
  • Sax PE; UNC Project-Malawi, Lilongwe, Malawi.
  • Stranix-Chibanda L; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA.
  • Lockman S; Harvard Medical School, Boston, MA; and.
J Acquir Immune Defic Syndr ; 97(2): 172-179, 2024 Oct 01.
Article en En | MEDLINE | ID: mdl-39250651
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Densidad Ósea / Infecciones por VIH / Fármacos Anti-VIH / Periodo Posparto Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: J Acquir Immune Defic Syndr Asunto de la revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Año: 2024 Tipo del documento: Article País de afiliación: Botswana Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Densidad Ósea / Infecciones por VIH / Fármacos Anti-VIH / Periodo Posparto Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: J Acquir Immune Defic Syndr Asunto de la revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Año: 2024 Tipo del documento: Article País de afiliación: Botswana Pais de publicación: Estados Unidos