Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.

Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.

<h4>Background</h4>Malnutrition is highly prevalent in HIV-exposed perinatally uninfected infants (HEUs) increasing the risk of morbidity and mortality throughout the life course. We set out to compare the effect of postnatal exposure to maternal antiretroviral therapy (mART) in breastmi...

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Autores principales: Lynda Stranix-Chibanda, Camlin Tierney, Mauricio Pinilla, Kathleen George, Jim Aizire, Godwin Chipoka, Macpherson Mallewa, Megeshinee Naidoo, Teacler Nematadzira, Bangani Kusakara, Avy Violari, Tapiwa Mbengeranwa, Boniface Njau, Lee Fairlie, Gerard Theron, Mwangelwa Mubiana-Mbewe, Sandhya Khadse, Renee Browning, Mary Glenn Fowler, George K Siberry, PROMISE Study Team
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Publicado: Public Library of Science (PLoS) 2021
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spelling oai:doaj.org-article:5b581a728ea141ebaf83676047605aad2021-12-02T20:14:57ZEffect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.1932-620310.1371/journal.pone.0255250https://doaj.org/article/5b581a728ea141ebaf83676047605aad2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0255250https://doaj.org/toc/1932-6203<h4>Background</h4>Malnutrition is highly prevalent in HIV-exposed perinatally uninfected infants (HEUs) increasing the risk of morbidity and mortality throughout the life course. We set out to compare the effect of postnatal exposure to maternal antiretroviral therapy (mART) in breastmilk versus infant Nevirapine prophylaxis (iNVP) on somatic growth of HEUs in the randomized PROMISE trial.<h4>Methods and findings</h4>We randomized 2431 mothers with HIV and their 2444 HEUs from six African countries and India 6-14 days after delivery to mART or iNVP for prevention of breastmilk HIV transmission. The mART regimen contained tenofovir/emtricitabine (99%) plus lopinavir/ritonavir. Infant growth parameters were compared at postnatal week 10, 26, 74 and 104 using World Health Organization (WHO) z-scores for length-for-age (LAZ), weight-for-age (WAZ), and head circumference-for-age (HCAZ). Week 26 LAZ was the primary endpoint measure. Student T-tests compared mean LAZ, WAZ, and HCAZ; estimated mean and 95% confidence interval (CI) are presented. Maternal and infant baseline characteristics were comparable between study arms. The estimated median breastfeeding duration was 70 weeks. After a mean follow-up of 88 weeks, mean LAZ and WAZ were below the WHO reference population mean at all timepoints, whereas mean HCAZ was not. The mART and iNVP arms did not differ for the primary outcome measure of LAZ at week 26 (p-value = 0.39; estimated mean difference (95%CI) of -0.05 (-0.18, 0.07)) or any of the other secondary growth outcome measures or timepoints (all p-values≥0.16). Secondary analyses of the primary outcome measure adjusting for week 0 LAZ and other covariates did not change these results (all p-values≥0.09). However, infants assigned to mART were more likely to have stunting compared to iNVP infants at week 26 (odds ratio (95% CI): 1.28 (1.05, 1.57)).<h4>Conclusions</h4>In HEUs, growth effects from postnatal exposure to mART compared to iNVP were comparable for measures on length, weight and head circumference with no clinically relevant differences between the groups. Despite breastfeeding into the second year of life, length and weight were below reference population means at all ages in both arms. Further investment is needed to optimize postnatal growth of infants born to women with HIV.<h4>Clinical trial registration</h4>ClinicalTrials.gov number NCT01061151.Lynda Stranix-ChibandaCamlin TierneyMauricio PinillaKathleen GeorgeJim AizireGodwin ChipokaMacpherson MallewaMegeshinee NaidooTeacler NematadziraBangani KusakaraAvy ViolariTapiwa MbengeranwaBoniface NjauLee FairlieGerard TheronMwangelwa Mubiana-MbeweSandhya KhadseRenee BrowningMary Glenn FowlerGeorge K SiberryPROMISE Study TeamPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 8, p e0255250 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Lynda Stranix-Chibanda
Camlin Tierney
Mauricio Pinilla
Kathleen George
Jim Aizire
Godwin Chipoka
Macpherson Mallewa
Megeshinee Naidoo
Teacler Nematadzira
Bangani Kusakara
Avy Violari
Tapiwa Mbengeranwa
Boniface Njau
Lee Fairlie
Gerard Theron
Mwangelwa Mubiana-Mbewe
Sandhya Khadse
Renee Browning
Mary Glenn Fowler
George K Siberry
PROMISE Study Team
Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
description <h4>Background</h4>Malnutrition is highly prevalent in HIV-exposed perinatally uninfected infants (HEUs) increasing the risk of morbidity and mortality throughout the life course. We set out to compare the effect of postnatal exposure to maternal antiretroviral therapy (mART) in breastmilk versus infant Nevirapine prophylaxis (iNVP) on somatic growth of HEUs in the randomized PROMISE trial.<h4>Methods and findings</h4>We randomized 2431 mothers with HIV and their 2444 HEUs from six African countries and India 6-14 days after delivery to mART or iNVP for prevention of breastmilk HIV transmission. The mART regimen contained tenofovir/emtricitabine (99%) plus lopinavir/ritonavir. Infant growth parameters were compared at postnatal week 10, 26, 74 and 104 using World Health Organization (WHO) z-scores for length-for-age (LAZ), weight-for-age (WAZ), and head circumference-for-age (HCAZ). Week 26 LAZ was the primary endpoint measure. Student T-tests compared mean LAZ, WAZ, and HCAZ; estimated mean and 95% confidence interval (CI) are presented. Maternal and infant baseline characteristics were comparable between study arms. The estimated median breastfeeding duration was 70 weeks. After a mean follow-up of 88 weeks, mean LAZ and WAZ were below the WHO reference population mean at all timepoints, whereas mean HCAZ was not. The mART and iNVP arms did not differ for the primary outcome measure of LAZ at week 26 (p-value = 0.39; estimated mean difference (95%CI) of -0.05 (-0.18, 0.07)) or any of the other secondary growth outcome measures or timepoints (all p-values≥0.16). Secondary analyses of the primary outcome measure adjusting for week 0 LAZ and other covariates did not change these results (all p-values≥0.09). However, infants assigned to mART were more likely to have stunting compared to iNVP infants at week 26 (odds ratio (95% CI): 1.28 (1.05, 1.57)).<h4>Conclusions</h4>In HEUs, growth effects from postnatal exposure to mART compared to iNVP were comparable for measures on length, weight and head circumference with no clinically relevant differences between the groups. Despite breastfeeding into the second year of life, length and weight were below reference population means at all ages in both arms. Further investment is needed to optimize postnatal growth of infants born to women with HIV.<h4>Clinical trial registration</h4>ClinicalTrials.gov number NCT01061151.
format article
author Lynda Stranix-Chibanda
Camlin Tierney
Mauricio Pinilla
Kathleen George
Jim Aizire
Godwin Chipoka
Macpherson Mallewa
Megeshinee Naidoo
Teacler Nematadzira
Bangani Kusakara
Avy Violari
Tapiwa Mbengeranwa
Boniface Njau
Lee Fairlie
Gerard Theron
Mwangelwa Mubiana-Mbewe
Sandhya Khadse
Renee Browning
Mary Glenn Fowler
George K Siberry
PROMISE Study Team
author_facet Lynda Stranix-Chibanda
Camlin Tierney
Mauricio Pinilla
Kathleen George
Jim Aizire
Godwin Chipoka
Macpherson Mallewa
Megeshinee Naidoo
Teacler Nematadzira
Bangani Kusakara
Avy Violari
Tapiwa Mbengeranwa
Boniface Njau
Lee Fairlie
Gerard Theron
Mwangelwa Mubiana-Mbewe
Sandhya Khadse
Renee Browning
Mary Glenn Fowler
George K Siberry
PROMISE Study Team
author_sort Lynda Stranix-Chibanda
title Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
title_short Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
title_full Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
title_fullStr Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
title_full_unstemmed Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
title_sort effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among hiv-exposed perinatally uninfected infants in the promise randomized trial.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/5b581a728ea141ebaf83676047605aad
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