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

Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe. University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe. Department of Biostatistics, Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Johns Hopkins University Research Collaboration, Makerere University, Kampala, Uganda. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MA, United States of America. Radiology Department, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Zimbabwe. Perinatal HIV Research Unit, Johannesburg, South Africa. Stellenbosch University, Cape Town, South Africa. Centre Aids Prevention Research South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa. FHI 360, IMPAACT Operations Center, Durham, NC, United States of America. Radiology and Biomedical Imaging Unit, University of California San Francisco, San Francisco, CA, United States of America. Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MA, United States of America. Research Department, Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, United States of America. University of Hawaii Cancer Center, Honolulu, Hawaii. Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MA, United States of America. United States Agency for International Development, Arlington, VA, United States of America.

PloS one. 2021;(2):e0246272
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Abstract

OBJECTIVES 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. DESIGN IMPAACT P1084s is a sub-study of the PROMISE randomized trial conducted in four African countries (ClinicalTrials.gov number NCT01066858). METHODS 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. RESULTS 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. CONCLUSIONS 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.

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Publication Type : Randomized Controlled Trial

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