Safety of Perinatal Exposure to Antiretroviral Medications: Developmental Outcomes in Infants
Identifieur interne : 001D19 ( Pmc/Corpus ); précédent : 001D18; suivant : 001D20Safety of Perinatal Exposure to Antiretroviral Medications: Developmental Outcomes in Infants
Auteurs : Patricia A. Sirois ; Yanling Huo ; Paige L. Williams ; Kathleen Malee ; Patricia A. Garvie ; Betsy Kammerer ; Kenneth Rich ; Russell B. Van Dyke ; Molly L. NozyceSource :
- The Pediatric infectious disease journal [ 0891-3668 ] ; 2013.
Abstract
This study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants.
HIV-exposed, uninfected infants (age 9-15 months) enrolled in SMARTT, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development—Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development, and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class), and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates.
As of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black, 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (PIs; 9% of PI-containing regimens also included non-nucleoside reverse transcriptase inhibitors [NNRTIs]), 5% to regimens containing NNRTIs (without PI), and 14% to regimens containing only nucleoside reverse transcriptase inhibitors (NRTIs). Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen, or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (p=0.01).
These results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.
Url:
DOI: 10.1097/INF.0b013e318284129a
PubMed: 23340561
PubMed Central: 3723344
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Williams</name><affiliation><nlm:aff id="A2">Harvard School of Public Health</nlm:aff></affiliation></author><author><name sortKey="Malee, Kathleen" sort="Malee, Kathleen" uniqKey="Malee K" first="Kathleen" last="Malee">Kathleen Malee</name><affiliation><nlm:aff id="A3">Northwestern University Feinberg School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Garvie, Patricia A" sort="Garvie, Patricia A" uniqKey="Garvie P" first="Patricia A." last="Garvie">Patricia A. Garvie</name><affiliation><nlm:aff id="A4">Consulting Psychologist</nlm:aff></affiliation></author><author><name sortKey="Kammerer, Betsy" sort="Kammerer, Betsy" uniqKey="Kammerer B" first="Betsy" last="Kammerer">Betsy Kammerer</name><affiliation><nlm:aff id="A5">Children’s Hospital Boston</nlm:aff></affiliation></author><author><name sortKey="Rich, Kenneth" sort="Rich, Kenneth" uniqKey="Rich K" first="Kenneth" last="Rich">Kenneth Rich</name><affiliation><nlm:aff id="A6">University of Illinois at Chicago</nlm:aff></affiliation></author><author><name sortKey="Van Dyke, Russell B" sort="Van Dyke, Russell B" uniqKey="Van Dyke R" first="Russell B." last="Van Dyke">Russell B. Van Dyke</name><affiliation><nlm:aff id="A1">Tulane University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Nozyce, Molly L" sort="Nozyce, Molly L" uniqKey="Nozyce M" first="Molly L." last="Nozyce">Molly L. Nozyce</name><affiliation><nlm:aff id="A7">Jacobi Medical Center, Albert Einstein College of Medicine</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23340561</idno><idno type="pmc">3723344</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3723344</idno><idno type="RBID">PMC:3723344</idno><idno type="doi">10.1097/INF.0b013e318284129a</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">001D19</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001D19</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Safety of Perinatal Exposure to Antiretroviral Medications: Developmental Outcomes in Infants</title><author><name sortKey="Sirois, Patricia A" sort="Sirois, Patricia A" uniqKey="Sirois P" first="Patricia A." last="Sirois">Patricia A. Sirois</name><affiliation><nlm:aff id="A1">Tulane University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Huo, Yanling" sort="Huo, Yanling" uniqKey="Huo Y" first="Yanling" last="Huo">Yanling Huo</name><affiliation><nlm:aff id="A2">Harvard School of Public Health</nlm:aff></affiliation></author><author><name sortKey="Williams, Paige L" sort="Williams, Paige L" uniqKey="Williams P" first="Paige L." last="Williams">Paige L. Williams</name><affiliation><nlm:aff id="A2">Harvard School of Public Health</nlm:aff></affiliation></author><author><name sortKey="Malee, Kathleen" sort="Malee, Kathleen" uniqKey="Malee K" first="Kathleen" last="Malee">Kathleen Malee</name><affiliation><nlm:aff id="A3">Northwestern University Feinberg School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Garvie, Patricia A" sort="Garvie, Patricia A" uniqKey="Garvie P" first="Patricia A." last="Garvie">Patricia A. Garvie</name><affiliation><nlm:aff id="A4">Consulting Psychologist</nlm:aff></affiliation></author><author><name sortKey="Kammerer, Betsy" sort="Kammerer, Betsy" uniqKey="Kammerer B" first="Betsy" last="Kammerer">Betsy Kammerer</name><affiliation><nlm:aff id="A5">Children’s Hospital Boston</nlm:aff></affiliation></author><author><name sortKey="Rich, Kenneth" sort="Rich, Kenneth" uniqKey="Rich K" first="Kenneth" last="Rich">Kenneth Rich</name><affiliation><nlm:aff id="A6">University of Illinois at Chicago</nlm:aff></affiliation></author><author><name sortKey="Van Dyke, Russell B" sort="Van Dyke, Russell B" uniqKey="Van Dyke R" first="Russell B." last="Van Dyke">Russell B. Van Dyke</name><affiliation><nlm:aff id="A1">Tulane University School of Medicine</nlm:aff></affiliation></author><author><name sortKey="Nozyce, Molly L" sort="Nozyce, Molly L" uniqKey="Nozyce M" first="Molly L." last="Nozyce">Molly L. Nozyce</name><affiliation><nlm:aff id="A7">Jacobi Medical Center, Albert Einstein College of Medicine</nlm:aff></affiliation></author></analytic><series><title level="j">The Pediatric infectious disease journal</title><idno type="ISSN">0891-3668</idno><idno type="eISSN">1532-0987</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">This study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants.</p></sec><sec id="S2"><title>Methods</title><p id="P2">HIV-exposed, uninfected infants (age 9-15 months) enrolled in SMARTT, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development—Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development, and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class), and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates.</p></sec><sec id="S3"><title>Results</title><p id="P3">As of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black, 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (PIs; 9% of PI-containing regimens also included non-nucleoside reverse transcriptase inhibitors [NNRTIs]), 5% to regimens containing NNRTIs (without PI), and 14% to regimens containing only nucleoside reverse transcriptase inhibitors (NRTIs). Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen, or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (p=0.01).</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">These results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">8701858</journal-id><journal-id journal-id-type="pubmed-jr-id">6404</journal-id><journal-id journal-id-type="nlm-ta">Pediatr Infect Dis J</journal-id><journal-id journal-id-type="iso-abbrev">Pediatr. Infect. Dis. J.</journal-id><journal-title-group><journal-title>The Pediatric infectious disease journal</journal-title></journal-title-group><issn pub-type="ppub">0891-3668</issn><issn pub-type="epub">1532-0987</issn></journal-meta><article-meta><article-id pub-id-type="pmid">23340561</article-id><article-id pub-id-type="pmc">3723344</article-id><article-id pub-id-type="doi">10.1097/INF.0b013e318284129a</article-id><article-id pub-id-type="manuscript">NIHMS437743</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Safety of Perinatal Exposure to Antiretroviral Medications: Developmental Outcomes in Infants</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Sirois</surname><given-names>Patricia A.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Huo</surname><given-names>Yanling</given-names></name><degrees>MS</degrees><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Williams</surname><given-names>Paige L.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Malee</surname><given-names>Kathleen</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Garvie</surname><given-names>Patricia A.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Kammerer</surname><given-names>Betsy</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Rich</surname><given-names>Kenneth</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Van Dyke</surname><given-names>Russell B.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Nozyce</surname><given-names>Molly L.</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><on-behalf-of>for the Pediatric HIV/AIDS Cohort Study</on-behalf-of></contrib-group><aff id="A1"><label>1</label>Tulane University School of Medicine</aff><aff id="A2"><label>2</label>Harvard School of Public Health</aff><aff id="A3"><label>3</label>Northwestern University Feinberg School of Medicine</aff><aff id="A4"><label>4</label>Consulting Psychologist</aff><aff id="A5"><label>5</label>Children’s Hospital Boston</aff><aff id="A6"><label>6</label>University of Illinois at Chicago</aff><aff id="A7"><label>7</label>Jacobi Medical Center, Albert Einstein College of Medicine</aff><author-notes><corresp id="CR1">Corresponding author: Patricia A. Sirois, PhD, Department of Pediatrics, Tulane University School of Medicine, 1430 Tulane Avenue (TW-41), New Orleans, LA, 70112; telephone: 504-988-6011; fax: 504-988-6014; <email>psirois@tulane.edu</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>19</day><month>6</month><year>2013</year></pub-date><pub-date pub-type="ppub"><month>6</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>6</month><year>2014</year></pub-date><volume>32</volume><issue>6</issue><fpage>648</fpage><lpage>655</lpage><abstract><sec id="S1"><title>Background</title><p id="P1">This study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants.</p></sec><sec id="S2"><title>Methods</title><p id="P2">HIV-exposed, uninfected infants (age 9-15 months) enrolled in SMARTT, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development—Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development, and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class), and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates.</p></sec><sec id="S3"><title>Results</title><p id="P3">As of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black, 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (PIs; 9% of PI-containing regimens also included non-nucleoside reverse transcriptase inhibitors [NNRTIs]), 5% to regimens containing NNRTIs (without PI), and 14% to regimens containing only nucleoside reverse transcriptase inhibitors (NRTIs). Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen, or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (p=0.01).</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">These results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.</p></sec></abstract><kwd-group><kwd>HIV</kwd><kwd>ARV</kwd><kwd>infant</kwd><kwd>neurodevelopment</kwd><kwd>developmental assessment</kwd></kwd-group><funding-group><award-group><funding-source country="United States">National Institute of Child Health & Human Development : NICHD</funding-source><award-id>U01 HD052104 || HD</award-id></award-group><award-group><funding-source country="United States">National Institute of Child Health & Human Development : NICHD</funding-source><award-id>U01 HD052102 || HD</award-id></award-group></funding-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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