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Impact of tenofovir-containing triple antiretroviral therapy (ART) on bone mineral density in HIV-infected breastfeeding women in sub-Saharan Africa PowerPoint Presentation

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Description : Impact of tenofovir-containing triple antiretroviral therapy (ART) on bone mineral density in HIV-infected breastfeeding women in sub-Saharan Africa.

Tags : Pediatrics, Child Health, pediatric practice, pediatrician, health providers, HIV-infected infants, Adolescent Transition, HIV-infected adolescents, epidemiology, south Africa, nutrition, breastfeeding, antiretroviral therapy

Published on : Jul 18, 2020 | Views : 1896 | Downloads : 1

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Slide 1-

Impact of tenofovir-containing triple antiretroviral therapy (ART) on bone mineral density in HIV-infected breastfeeding women in sub-Saharan Africa Lynda Stranix-Chibanda for the PROMISE P1084s Study Team O_20
Slide 2-

Co-Authors C. Tierney C. Marr K. George D. Sebikari S. Dadabhai A. Zanga C. Mukwasi-Kahari T. Vhembo A. Violari G. Theron D. Moodley B. Fan M. Basar R. Browning L. Mofenson J. Shepherd M.G. Fowler G. Siberry PROMISE P1084s study team 2
Slide 3-

Background and Rationale 3 HIV-infected mothers in resource limited settings are at risk of low bone mineral density (BMD) HIV infection increases risk of low BMD BMD declines during lactation (3-10% at 12 months) Antiretroviral drug (ARV) use is also known to decrease BMD Concern about adverse tenofovir (TDF) impact on bones Low BMD reported in children, adolescents & adults on TDF-ART Significant BMD declines seen even without HIV (on PrEP)
Slide 4-

Objective 4 To address concerns about the potential adverse impact on BMD of ARV use during breastfeeding, we evaluated the effect of postnatal ARV exposure on BMD among HIV-infected breastfeeding women enrolled in the bone and kidney health sub-study of the PROMISE trial – IMPAACT P1084s : Postpartum Component
Slide 5-

Study design – Postpartum Component 5 Sub-study of PROMISE Zimbabwe, Uganda, South Africa and Malawi A sub-set of HIV-infected women and their uninfected healthy infants who had been randomized in the PROMISE Postpartum Component were offered co-enrolment in P1084s Did not meet existing criteria for ART initiation ART not standard at the time
Slide 6-

R Postpartum Women & Infants Up to 14 days after delivery Maternal Triple ART during breastfeeding [TDF / FTC / LPV/r ] No Maternal ART during breastfeeding [Infant NVP prophylaxis] PROMISE Postpartum Randomization 6
Slide 7-

Maternal BMD assessments 7 BMD lumbar spine and hip Baseline measurement soon after delivery (day 5-21, “week 1”) 74 weeks after delivery (+/-6 weeks) Dual-energy x-ray absorptiometry (DXA) Standard procedures followed to minimise differences between the study sites Webinar training and quality review/approval of first scan for each technician Hologic scanners at all sites Cross-calibration with phantom DXA scans were read centrally
Slide 8-

Data Analysis 8 Compare Maternal ART to no maternal ART for percent change in BMD between week 1 and week 74 at the lumbar spine (primary outcome) and hip Analysed by assigned strategy with a t-test Mean and 95% confidence interval (CI) are presented
Slide 9-

R Postpartum Women & Infants Up to 14 days after delivery Maternal Triple ART during breastfeeding [TDF / FTC / LPV/r ] No Maternal ART during breastfeeding [Infant NVP prophylaxis] P1084s Postpartum Accrual 199 pairs included in analysis 9 n=400 n=202 n=198 198 pairs included in analysis
Slide 10-

Baseline Characteristics 10 At week 1 postpartum (6-14 days) Prior use of alcohol/tobacco 12% Median duration of breastfeeding 61 weeks No significant difference between study arms
Slide 11-

Lumbar spine BMD % decline week 1 to 74 greater in maternal ART study arm % change in spine BMD wk1 to wk74 No maternal ART N=170 Maternal Triple ART N=167 Mean difference of -3.16 % (-4.44, -1.84) (p-value <0.001) 11
Slide 12-

Hip BMD % decline week 1 to 74 greater in maternal ART study arm % change in hip BMD wk1 to wk74 No maternal ART N=166 Maternal Triple ART N=169 Mean difference of -2.33% (-3.23, -1.42) (p-value <0.001) 12
Slide 13-

Conclusions 13 BMD decline between week 1 and week 74 postpartum was statistically significantly greater among HIV-infected women receiving ART during breastfeeding compared to no ART These data indicate a negative effect on BMD of maternal ART use in the postpartum period – Not able to show if BMD returned to baseline after cessation of breastfeeding Highlight the importance of BMD in settings where breastfeeding is standard as we enter the Treat All era
Slide 14-

P1084s Protocol Team and Site Investigators The PROMISE study team gratefully acknowledges the dedication and commitment of the more than 3,500 mother-infants pairs without whom this study would not have been possible. 14 Protocol Chairs G Siberry, L Stranix-Chibanda PROMISE Parent Study Protocol Chairs MG Fowler, J McIntyre, P Flynn, T Chipato, J Currier Statistical and Data Management Center K Angelidou, M Basar, S Brummel, T Fenton, A Gonzalez, L Marillo, A Manzella, D Shapiro, C Tierney, M Warshaw, A Zadzilka Operations Center M Allen, A Coletti, K George, K McCarthy, M Valentine Field Representative M Toye Laboratory Center A Loftis, S Fiscus DXA Specialists J Sheppard, B Fan, E Stephens, J Yu Sponsors US NIH: R Browning, R Hazra, D Gnanashanmugam, L Purdue, N Chakhtoura, L Mofenson Gilead Sciences: J Rooney Site Investigators of Record Malawi: Blantyre: B Makanani, M Mallewa, S Dadabhai, T Taha South Africa: CAPRISA Umlazi, Durban: D Moodley, V Chetty, S Hanley, A Desmond FAM-CRU, Stellenbosch: G Theron, J Louw, L Rossouw, M Rossouw PHRU, Soweto: A Violari, S Dittmer, M Nyati, N Abrahams Uganda: MUJHU, Kampala: M Owor, D Sebikari, M Kamateeka, J Aizire Zimbabwe: Harare Family Care: C Mukwasi, T Mbengeranwa, T Vhembo, S Maturure Seke North: L Stranix-Chibanda, A Zanga, T Nematadzira, S Maonera St. Mary’s: T Chipato, B Kusakara, M Munjoma, E Marote
Slide 15-

Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network was provided by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) under Award Numbers UM1AI068632 (IMPAACT LOC), UM1AI068616 (IMPAACT SDMC) and UM1AI106716 (IMPAACT LC), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH). The content of this presentation is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Antiretrovirals were provided free of charge for the PROMISE 1077BF and P1084s studies by AbbVie, Gilead Sciences, and GlaxoSmithKline. The PROMISE Study is funded by the US National Institutes of Health 15

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