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Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women

BACKGROUND: Studies in HIV-1-infected infants and HIV-1-exposed, uninfected infants link early cytomegalovirus (CMV) acquisition with growth delay and cognitive impairment. We investigated maternal valacyclovir to delay infant acquisition of CMV. METHODS: Pregnant women with HIV-1, HSV-2 and CD4 cou...

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Autores principales: Roxby, Alison C., Atkinson, Claire, Ásbjörnsdóttir, Kristjana, Farquhar, Carey, Kiarie, James N., Drake, Alison L., Wald, Anna, Boeckh, Michael, Richardson, Barbra, Emery, Vincent, John-Stewart, Grace, Slyker, Jennifer A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3913686/
https://www.ncbi.nlm.nih.gov/pubmed/24504006
http://dx.doi.org/10.1371/journal.pone.0087855
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author Roxby, Alison C.
Atkinson, Claire
Ásbjörnsdóttir, Kristjana
Farquhar, Carey
Kiarie, James N.
Drake, Alison L.
Wald, Anna
Boeckh, Michael
Richardson, Barbra
Emery, Vincent
John-Stewart, Grace
Slyker, Jennifer A.
author_facet Roxby, Alison C.
Atkinson, Claire
Ásbjörnsdóttir, Kristjana
Farquhar, Carey
Kiarie, James N.
Drake, Alison L.
Wald, Anna
Boeckh, Michael
Richardson, Barbra
Emery, Vincent
John-Stewart, Grace
Slyker, Jennifer A.
author_sort Roxby, Alison C.
collection PubMed
description BACKGROUND: Studies in HIV-1-infected infants and HIV-1-exposed, uninfected infants link early cytomegalovirus (CMV) acquisition with growth delay and cognitive impairment. We investigated maternal valacyclovir to delay infant acquisition of CMV. METHODS: Pregnant women with HIV-1, HSV-2 and CD4 count >250 cells/µl were randomized at 34 weeks gestation to 500 mg twice-daily valacyclovir or placebo for 12 months. Maternal CMV DNA was measured in plasma at 34 weeks gestation, in cervical secretions at 34 and 38 weeks gestation, and in breast milk at 7 postpartum timepoints; infant CMV DNA was measured in dried blood spots at 8 timepoints including birth. RESULTS: Among 148 women, 141 infants were compared in intent-to-treat analyses. Maternal and infant characteristics were similar between study arms. Infant CMV acquisition did not differ between study arms, with 46/70 infants (66%) in placebo arm and 47/71 infants (66%) in the valacyclovir arm acquiring CMV; median time to CMV detection did not differ. CMV DNA was detected in 92% of 542 breast milk specimens with no difference in CMV level between study arms. Change in cervical shedding of CMV DNA between baseline and 38 weeks was 0.40-log greater in the placebo arm than the valacyclovir arm (p = 0.05). CONCLUSIONS: In this cohort of HIV-1-seropositive mothers, two-thirds of infants acquired CMV by one year. Maternal valacyclovir had no effect on timing of infant CMV acquisition or breast milk CMV viral loads, although it modestly reduced cervical CMV shedding. Maternal prophylaxis to reduce infant CMV acquisition warrants further evaluation in trials with antiviral agents. TRIALS REGISTRATION: ClinicalTrials.gov NCT00530777
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spelling pubmed-39136862014-02-06 Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women Roxby, Alison C. Atkinson, Claire Ásbjörnsdóttir, Kristjana Farquhar, Carey Kiarie, James N. Drake, Alison L. Wald, Anna Boeckh, Michael Richardson, Barbra Emery, Vincent John-Stewart, Grace Slyker, Jennifer A. PLoS One Research Article BACKGROUND: Studies in HIV-1-infected infants and HIV-1-exposed, uninfected infants link early cytomegalovirus (CMV) acquisition with growth delay and cognitive impairment. We investigated maternal valacyclovir to delay infant acquisition of CMV. METHODS: Pregnant women with HIV-1, HSV-2 and CD4 count >250 cells/µl were randomized at 34 weeks gestation to 500 mg twice-daily valacyclovir or placebo for 12 months. Maternal CMV DNA was measured in plasma at 34 weeks gestation, in cervical secretions at 34 and 38 weeks gestation, and in breast milk at 7 postpartum timepoints; infant CMV DNA was measured in dried blood spots at 8 timepoints including birth. RESULTS: Among 148 women, 141 infants were compared in intent-to-treat analyses. Maternal and infant characteristics were similar between study arms. Infant CMV acquisition did not differ between study arms, with 46/70 infants (66%) in placebo arm and 47/71 infants (66%) in the valacyclovir arm acquiring CMV; median time to CMV detection did not differ. CMV DNA was detected in 92% of 542 breast milk specimens with no difference in CMV level between study arms. Change in cervical shedding of CMV DNA between baseline and 38 weeks was 0.40-log greater in the placebo arm than the valacyclovir arm (p = 0.05). CONCLUSIONS: In this cohort of HIV-1-seropositive mothers, two-thirds of infants acquired CMV by one year. Maternal valacyclovir had no effect on timing of infant CMV acquisition or breast milk CMV viral loads, although it modestly reduced cervical CMV shedding. Maternal prophylaxis to reduce infant CMV acquisition warrants further evaluation in trials with antiviral agents. TRIALS REGISTRATION: ClinicalTrials.gov NCT00530777 Public Library of Science 2014-02-04 /pmc/articles/PMC3913686/ /pubmed/24504006 http://dx.doi.org/10.1371/journal.pone.0087855 Text en © 2014 Roxby et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Roxby, Alison C.
Atkinson, Claire
Ásbjörnsdóttir, Kristjana
Farquhar, Carey
Kiarie, James N.
Drake, Alison L.
Wald, Anna
Boeckh, Michael
Richardson, Barbra
Emery, Vincent
John-Stewart, Grace
Slyker, Jennifer A.
Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women
title Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women
title_full Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women
title_fullStr Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women
title_full_unstemmed Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women
title_short Maternal Valacyclovir and Infant Cytomegalovirus Acquisition: A Randomized Controlled Trial among HIV-Infected Women
title_sort maternal valacyclovir and infant cytomegalovirus acquisition: a randomized controlled trial among hiv-infected women
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3913686/
https://www.ncbi.nlm.nih.gov/pubmed/24504006
http://dx.doi.org/10.1371/journal.pone.0087855
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