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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Association Between Efavirenz-Based Compared With Nevirapine-Based Antiretroviral Regimens and Virological Failure in HIV-Infected Children</title>
<author><name sortKey="Lowenthal, Elizabeth D" sort="Lowenthal, Elizabeth D" uniqKey="Lowenthal E" first="Elizabeth D." last="Lowenthal">Elizabeth D. Lowenthal</name>
</author>
<author><name sortKey="Ellenberg, Jonas H" sort="Ellenberg, Jonas H" uniqKey="Ellenberg J" first="Jonas H." last="Ellenberg">Jonas H. Ellenberg</name>
</author>
<author><name sortKey="Machine, Edwin" sort="Machine, Edwin" uniqKey="Machine E" first="Edwin" last="Machine">Edwin Machine</name>
</author>
<author><name sortKey="Sagdeo, Aditi" sort="Sagdeo, Aditi" uniqKey="Sagdeo A" first="Aditi" last="Sagdeo">Aditi Sagdeo</name>
</author>
<author><name sortKey="Boiditswe, Sefelani" sort="Boiditswe, Sefelani" uniqKey="Boiditswe S" first="Sefelani" last="Boiditswe">Sefelani Boiditswe</name>
</author>
<author><name sortKey="Steenhoff, Andrew P" sort="Steenhoff, Andrew P" uniqKey="Steenhoff A" first="Andrew P." last="Steenhoff">Andrew P. Steenhoff</name>
</author>
<author><name sortKey="Rutstein, Richard" sort="Rutstein, Richard" uniqKey="Rutstein R" first="Richard" last="Rutstein">Richard Rutstein</name>
</author>
<author><name sortKey="Anabwani, Gabriel" sort="Anabwani, Gabriel" uniqKey="Anabwani G" first="Gabriel" last="Anabwani">Gabriel Anabwani</name>
</author>
<author><name sortKey="Gross, Robert" sort="Gross, Robert" uniqKey="Gross R" first="Robert" last="Gross">Robert Gross</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">23632724</idno>
<idno type="pmc">3748602</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3748602</idno>
<idno type="RBID">PMC:3748602</idno>
<idno type="doi">10.1001/jama.2013.3710</idno>
<date when="2013">2013</date>
<idno type="wicri:Area/Pmc/Corpus">001B55</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001B55</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Association Between Efavirenz-Based Compared With Nevirapine-Based Antiretroviral Regimens and Virological Failure in HIV-Infected Children</title>
<author><name sortKey="Lowenthal, Elizabeth D" sort="Lowenthal, Elizabeth D" uniqKey="Lowenthal E" first="Elizabeth D." last="Lowenthal">Elizabeth D. Lowenthal</name>
</author>
<author><name sortKey="Ellenberg, Jonas H" sort="Ellenberg, Jonas H" uniqKey="Ellenberg J" first="Jonas H." last="Ellenberg">Jonas H. Ellenberg</name>
</author>
<author><name sortKey="Machine, Edwin" sort="Machine, Edwin" uniqKey="Machine E" first="Edwin" last="Machine">Edwin Machine</name>
</author>
<author><name sortKey="Sagdeo, Aditi" sort="Sagdeo, Aditi" uniqKey="Sagdeo A" first="Aditi" last="Sagdeo">Aditi Sagdeo</name>
</author>
<author><name sortKey="Boiditswe, Sefelani" sort="Boiditswe, Sefelani" uniqKey="Boiditswe S" first="Sefelani" last="Boiditswe">Sefelani Boiditswe</name>
</author>
<author><name sortKey="Steenhoff, Andrew P" sort="Steenhoff, Andrew P" uniqKey="Steenhoff A" first="Andrew P." last="Steenhoff">Andrew P. Steenhoff</name>
</author>
<author><name sortKey="Rutstein, Richard" sort="Rutstein, Richard" uniqKey="Rutstein R" first="Richard" last="Rutstein">Richard Rutstein</name>
</author>
<author><name sortKey="Anabwani, Gabriel" sort="Anabwani, Gabriel" uniqKey="Anabwani G" first="Gabriel" last="Anabwani">Gabriel Anabwani</name>
</author>
<author><name sortKey="Gross, Robert" sort="Gross, Robert" uniqKey="Gross R" first="Robert" last="Gross">Robert Gross</name>
</author>
</analytic>
<series><title level="j">JAMA : the journal of the American Medical Association</title>
<idno type="ISSN">0098-7484</idno>
<idno type="eISSN">1538-3598</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>Importance</title>
<p id="P1">Worldwide, the nonnucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz and nevirapine are commonly used in first-line antiretroviral regimens in both adults and children with human immunodeficiency virus (HIV) infection. Data on the comparative effectiveness of these medications in children are limited.</p>
</sec>
<sec id="S2"><title>Objective</title>
<p id="P2">To investigate whether virological failure is more likely among children who initiated 1 or the other NNRTI-based HIV treatment.</p>
</sec>
<sec id="S3"><title>Design, Setting, and Participants</title>
<p id="P3">Retrospective cohort study of children (aged 3–16 years) who initiated efavirenz-based (n=421) or nevirapine-based (n=383) treatment between April 2002 and January 2011 at a large pediatric HIV care setting in Botswana.</p>
</sec>
<sec id="S4"><title>Main Outcomes and Measures</title>
<p id="P4">The primary outcome was time from initiation of therapy to virological failure. Virological failure was defined as lack of plasma HIV RNA suppression to less than 400 copies/mL by 6 months or confirmed HIV RNA of 400 copies/mL or greater after suppression. Cox proportional hazards regression analysis compared time to virological failure by regimen. Multivariable Cox regression controlled for age, sex, baseline immunologic category, baseline clinical category, baseline viral load, nutritional status, NRTIs used, receipt of single-dose nevirapine, and treatment for tuberculosis.</p>
</sec>
<sec id="S5"><title>Results</title>
<p id="P5">With a median follow-up time of 69 months (range, 6–112 months; interquartile range, 23–87 months), 57 children (13.5%; 95% CI, 10.4%–17.2%) initiating treatment with efavirenz and 101 children (26.4%; 95% CI, 22.0%–31.1%) initiating treatment with nevirapine had virological failure. There were 11 children (2.6%; 95% CI, 1.3%–4.6%) receiving efavirenz and 20 children (5.2%; 95% CI, 3.2%–7.9%) receiving nevirapine who never achieved virological suppression. The Cox proportional hazard ratio for the combined virological failure end point was 2.0 (95% CI, 1.4–2.7; log rank <italic>P</italic>
<.001, favoring efavirenz). None of the measured covariates affected the estimated hazard ratio in the multivariable analyses.</p>
</sec>
<sec id="S6"><title>Conclusions and Relevance</title>
<p id="P6">Among children aged 3 to 16 years infected with HIV and treated at a clinic in Botswana, the use of efavirenz compared with nevirapine as initial antiretroviral treatment was associated with less virological failure. These findings may warrant additional research evaluating the use of efavirenz and nevirapine for pediatric patients.</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">7501160</journal-id>
<journal-id journal-id-type="pubmed-jr-id">5346</journal-id>
<journal-id journal-id-type="nlm-ta">JAMA</journal-id>
<journal-id journal-id-type="iso-abbrev">JAMA</journal-id>
<journal-title-group><journal-title>JAMA : the journal of the American Medical Association</journal-title>
</journal-title-group>
<issn pub-type="ppub">0098-7484</issn>
<issn pub-type="epub">1538-3598</issn>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">23632724</article-id>
<article-id pub-id-type="pmc">3748602</article-id>
<article-id pub-id-type="doi">10.1001/jama.2013.3710</article-id>
<article-id pub-id-type="manuscript">NIHMS505218</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Association Between Efavirenz-Based Compared With Nevirapine-Based Antiretroviral Regimens and Virological Failure in HIV-Infected Children</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Lowenthal</surname>
<given-names>Elizabeth D.</given-names>
</name>
<degrees>MD, MSCE</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Ellenberg</surname>
<given-names>Jonas H.</given-names>
</name>
<degrees>PhD</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Machine</surname>
<given-names>Edwin</given-names>
</name>
<degrees>MPH</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Sagdeo</surname>
<given-names>Aditi</given-names>
</name>
<degrees>BS</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Boiditswe</surname>
<given-names>Sefelani</given-names>
</name>
<degrees>BNSc</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Steenhoff</surname>
<given-names>Andrew P.</given-names>
</name>
<degrees>MBBCh</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Rutstein</surname>
<given-names>Richard</given-names>
</name>
<degrees>MD</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Anabwani</surname>
<given-names>Gabriel</given-names>
</name>
<degrees>MBChB, MSc</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Gross</surname>
<given-names>Robert</given-names>
</name>
<degrees>MD, MSCE</degrees>
</contrib>
<aff id="A1">Departments of Pediatrics (Drs Lowenthal, Steenhoff, and Rutstein and Ms Sagdeo), Biostatistics and Epidemiology (Drs Lowenthal and Ellenberg), and Medicine and Epidemiology (Dr Gross), University of Pennsylvania Perelman School of Medicine, Philadelphia; Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (Drs Lowenthal, Steenhoff, and Rutstein); Botswana-UPenn Partnership, Gaborone (Drs Lowenthal, Steenhoff, and Gross); Botswana-Baylor Children's Clinical Centre of Excellence, Gaborone (Mr Machine, Ms Boiditswe, and Dr Anabwani); and Baylor College of Medicine, Houston, Texas (Mr Machine and Dr Anabwani)</aff>
</contrib-group>
<author-notes><corresp id="CR1"><bold>Corresponding Author:</bold>
Elizabeth D. Lowenthal, MD, MSCE, University of Pennsylvania Perelman School of Medicine, 3535 Market St, Room 1513, Philadelphia, PA 19104 (<email>lowenthale@email.chop.edu</email>
).</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>13</day>
<month>8</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="ppub"><day>1</day>
<month>5</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>21</day>
<month>8</month>
<year>2013</year>
</pub-date>
<volume>309</volume>
<issue>17</issue>
<fpage>1803</fpage>
<lpage>1809</lpage>
<permissions><copyright-statement>©2013 American Medical Association. All rights reserved</copyright-statement>
<copyright-year>2013</copyright-year>
</permissions>
<abstract><sec id="S1"><title>Importance</title>
<p id="P1">Worldwide, the nonnucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz and nevirapine are commonly used in first-line antiretroviral regimens in both adults and children with human immunodeficiency virus (HIV) infection. Data on the comparative effectiveness of these medications in children are limited.</p>
</sec>
<sec id="S2"><title>Objective</title>
<p id="P2">To investigate whether virological failure is more likely among children who initiated 1 or the other NNRTI-based HIV treatment.</p>
</sec>
<sec id="S3"><title>Design, Setting, and Participants</title>
<p id="P3">Retrospective cohort study of children (aged 3–16 years) who initiated efavirenz-based (n=421) or nevirapine-based (n=383) treatment between April 2002 and January 2011 at a large pediatric HIV care setting in Botswana.</p>
</sec>
<sec id="S4"><title>Main Outcomes and Measures</title>
<p id="P4">The primary outcome was time from initiation of therapy to virological failure. Virological failure was defined as lack of plasma HIV RNA suppression to less than 400 copies/mL by 6 months or confirmed HIV RNA of 400 copies/mL or greater after suppression. Cox proportional hazards regression analysis compared time to virological failure by regimen. Multivariable Cox regression controlled for age, sex, baseline immunologic category, baseline clinical category, baseline viral load, nutritional status, NRTIs used, receipt of single-dose nevirapine, and treatment for tuberculosis.</p>
</sec>
<sec id="S5"><title>Results</title>
<p id="P5">With a median follow-up time of 69 months (range, 6–112 months; interquartile range, 23–87 months), 57 children (13.5%; 95% CI, 10.4%–17.2%) initiating treatment with efavirenz and 101 children (26.4%; 95% CI, 22.0%–31.1%) initiating treatment with nevirapine had virological failure. There were 11 children (2.6%; 95% CI, 1.3%–4.6%) receiving efavirenz and 20 children (5.2%; 95% CI, 3.2%–7.9%) receiving nevirapine who never achieved virological suppression. The Cox proportional hazard ratio for the combined virological failure end point was 2.0 (95% CI, 1.4–2.7; log rank <italic>P</italic>
<.001, favoring efavirenz). None of the measured covariates affected the estimated hazard ratio in the multivariable analyses.</p>
</sec>
<sec id="S6"><title>Conclusions and Relevance</title>
<p id="P6">Among children aged 3 to 16 years infected with HIV and treated at a clinic in Botswana, the use of efavirenz compared with nevirapine as initial antiretroviral treatment was associated with less virological failure. These findings may warrant additional research evaluating the use of efavirenz and nevirapine for pediatric patients.</p>
</sec>
</abstract>
<funding-group><award-group><funding-source country="United States">National Institute of Allergy and Infectious Diseases Extramural Activities : NIAID</funding-source>
<award-id>P30 AI045008 || AI</award-id>
</award-group>
<award-group><funding-source country="United States">National Institute of Allergy and Infectious Diseases Extramural Activities : NIAID</funding-source>
<award-id>P30 AI045008 || AI</award-id>
</award-group>
</funding-group>
</article-meta>
</front>
</pmc>
</record>
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