SINGLE DOSE NEVIRAPINE EXPOSURE DOES NOT AFFECT RESPONSE TO ANTI-RETROVIRAL THERAPY IN HIV-INFECTED AFRICAN CHILDREN AGED <3 YEARS
Identifieur interne : 003199 ( Ncbi/Merge ); précédent : 003198; suivant : 003200SINGLE DOSE NEVIRAPINE EXPOSURE DOES NOT AFFECT RESPONSE TO ANTI-RETROVIRAL THERAPY IN HIV-INFECTED AFRICAN CHILDREN AGED <3 YEARS
Auteurs : Philippa Musoke ; Alexander J. Szubert ; Victor Musiime ; Kusum Nathoo ; Patricia Nahirya-Ntege ; Kuda Mutasa ; David Eram Williams ; Andrew J. Prendergast ; Moira Spyer ; A Sarah Walker ; Diana M. GibbSource :
- AIDS (London, England) [ 0269-9370 ] ; 2015.
Abstract
To assess the impact of exposure to single-dose nevirapine (sdNVP) on virological response in young Ugandan/Zimbabwean children (<3 years) initiating antiretroviral therapy (ART), and investigate other predictors of response.
Observational analysis within the ARROW randomised trial.
sdNVP exposure was ascertained by caregiver’s self-report when the child initiated NNRTI based ART. Viral load (VL) was assayed retrospectively over median 4.1 years follow-up. Multivariable logistic regression models were used to identify independent predictors of VL <80 copies/ml 48 and 144 weeks after ART initiation (backwards elimination, exit p=0.1).
Median (IQR) age at ART initiation was 17 (10-23) months in 78 sdNVP exposed children versus 21 (14-27) months in 289 non-exposed children (36% vs 20% <12 months). At week 48, 49/73 (67%) sdNVP exposed and 154/272 (57%) non-exposed children had VL<80 copies/ml (adjusted (a)OR=2.34 [1.26-4.34] p=0.007); 79% and 77% had VL<400copies/ml. Suppression was significantly lower in males (p=0.009), those with higher pre-ART VL (p=0.001), taking syrups (p=0.05) and with lower self-reported adherence (p=0.04). At week 144, 55/73 (75%) exposed and 188/272 (69%) non-exposed had <80 copies/ml (aOR=1.75 [0.93-3.29] p=0.08). There was no difference between children with and without previous sdNVP exposure in intermediate/high-level resistance to NRTIs (p>0.3) or NNRTIs (p>0.1) (n=88) at week 144.
Given the limited global availability of lopinavir/ritonavir, its significant formulation challenges in young children, and the significant paediatric treatment gap, tablet fixed-dose-combination nevirapine-based ART remains a good alternative to syrup lopinavir-based ART for children, particularly those over one year and even if exposed to sdNVP.
Url:
DOI: 10.1097/QAD.0000000000000749
PubMed: 26193705
PubMed Central: 4833198
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<author><name sortKey="Musoke, Philippa" sort="Musoke, Philippa" uniqKey="Musoke P" first="Philippa" last="Musoke">Philippa Musoke</name>
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<author><name sortKey="Szubert, Alexander J" sort="Szubert, Alexander J" uniqKey="Szubert A" first="Alexander J" last="Szubert">Alexander J. Szubert</name>
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<author><name sortKey="Musiime, Victor" sort="Musiime, Victor" uniqKey="Musiime V" first="Victor" last="Musiime">Victor Musiime</name>
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<author><name sortKey="Nathoo, Kusum" sort="Nathoo, Kusum" uniqKey="Nathoo K" first="Kusum" last="Nathoo">Kusum Nathoo</name>
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<author><name sortKey="Nahirya Ntege, Patricia" sort="Nahirya Ntege, Patricia" uniqKey="Nahirya Ntege P" first="Patricia" last="Nahirya-Ntege">Patricia Nahirya-Ntege</name>
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<author><name sortKey="Mutasa, Kuda" sort="Mutasa, Kuda" uniqKey="Mutasa K" first="Kuda" last="Mutasa">Kuda Mutasa</name>
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<author><name sortKey="Williams, David Eram" sort="Williams, David Eram" uniqKey="Williams D" first="David Eram" last="Williams">David Eram Williams</name>
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<author><name sortKey="Prendergast, Andrew J" sort="Prendergast, Andrew J" uniqKey="Prendergast A" first="Andrew J." last="Prendergast">Andrew J. Prendergast</name>
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<author><name sortKey="Spyer, Moira" sort="Spyer, Moira" uniqKey="Spyer M" first="Moira" last="Spyer">Moira Spyer</name>
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<author><name sortKey="Walker, A Sarah" sort="Walker, A Sarah" uniqKey="Walker A" first="A Sarah" last="Walker">A Sarah Walker</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">SINGLE DOSE NEVIRAPINE EXPOSURE DOES NOT AFFECT RESPONSE TO ANTI-RETROVIRAL THERAPY IN HIV-INFECTED AFRICAN CHILDREN AGED <3 YEARS</title>
<author><name sortKey="Musoke, Philippa" sort="Musoke, Philippa" uniqKey="Musoke P" first="Philippa" last="Musoke">Philippa Musoke</name>
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<author><name sortKey="Szubert, Alexander J" sort="Szubert, Alexander J" uniqKey="Szubert A" first="Alexander J" last="Szubert">Alexander J. Szubert</name>
</author>
<author><name sortKey="Musiime, Victor" sort="Musiime, Victor" uniqKey="Musiime V" first="Victor" last="Musiime">Victor Musiime</name>
</author>
<author><name sortKey="Nathoo, Kusum" sort="Nathoo, Kusum" uniqKey="Nathoo K" first="Kusum" last="Nathoo">Kusum Nathoo</name>
</author>
<author><name sortKey="Nahirya Ntege, Patricia" sort="Nahirya Ntege, Patricia" uniqKey="Nahirya Ntege P" first="Patricia" last="Nahirya-Ntege">Patricia Nahirya-Ntege</name>
</author>
<author><name sortKey="Mutasa, Kuda" sort="Mutasa, Kuda" uniqKey="Mutasa K" first="Kuda" last="Mutasa">Kuda Mutasa</name>
</author>
<author><name sortKey="Williams, David Eram" sort="Williams, David Eram" uniqKey="Williams D" first="David Eram" last="Williams">David Eram Williams</name>
</author>
<author><name sortKey="Prendergast, Andrew J" sort="Prendergast, Andrew J" uniqKey="Prendergast A" first="Andrew J." last="Prendergast">Andrew J. Prendergast</name>
</author>
<author><name sortKey="Spyer, Moira" sort="Spyer, Moira" uniqKey="Spyer M" first="Moira" last="Spyer">Moira Spyer</name>
</author>
<author><name sortKey="Walker, A Sarah" sort="Walker, A Sarah" uniqKey="Walker A" first="A Sarah" last="Walker">A Sarah Walker</name>
</author>
<author><name sortKey="Gibb, Diana M" sort="Gibb, Diana M" uniqKey="Gibb D" first="Diana M" last="Gibb">Diana M. Gibb</name>
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<series><title level="j">AIDS (London, England)</title>
<idno type="ISSN">0269-9370</idno>
<idno type="eISSN">1473-5571</idno>
<imprint><date when="2015">2015</date>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Objectives</title>
<p id="P4">To assess the impact of exposure to single-dose nevirapine (sdNVP) on virological response in young Ugandan/Zimbabwean children (<3 years) initiating antiretroviral therapy (ART), and investigate other predictors of response.</p>
</sec>
<sec id="S2"><title>Design</title>
<p id="P5">Observational analysis within the ARROW randomised trial.</p>
</sec>
<sec id="S3"><title>Methods</title>
<p id="P6">sdNVP exposure was ascertained by caregiver’s self-report when the child initiated NNRTI based ART. Viral load (VL) was assayed retrospectively over median 4.1 years follow-up. Multivariable logistic regression models were used to identify independent predictors of VL <80 copies/ml 48 and 144 weeks after ART initiation (backwards elimination, exit p=0.1).</p>
</sec>
<sec id="S4"><title>Results</title>
<p id="P7">Median (IQR) age at ART initiation was 17 (10-23) months in 78 sdNVP exposed children versus 21 (14-27) months in 289 non-exposed children (36% vs 20% <12 months). At week 48, 49/73 (67%) sdNVP exposed and 154/272 (57%) non-exposed children had VL<80 copies/ml (adjusted (a)OR=2.34 [1.26-4.34] p=0.007); 79% and 77% had VL<400copies/ml. Suppression was significantly lower in males (p=0.009), those with higher pre-ART VL (p=0.001), taking syrups (p=0.05) and with lower self-reported adherence (p=0.04). At week 144, 55/73 (75%) exposed and 188/272 (69%) non-exposed had <80 copies/ml (aOR=1.75 [0.93-3.29] p=0.08). There was no difference between children with and without previous sdNVP exposure in intermediate/high-level resistance to NRTIs (p>0.3) or NNRTIs (p>0.1) (n=88) at week 144.</p>
</sec>
<sec id="S5"><title>Conclusion</title>
<p id="P8">Given the limited global availability of lopinavir/ritonavir, its significant formulation challenges in young children, and the significant paediatric treatment gap, tablet fixed-dose-combination nevirapine-based ART remains a good alternative to syrup lopinavir-based ART for children, particularly those over one year and even if exposed to sdNVP.</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">8710219</journal-id>
<journal-id journal-id-type="pubmed-jr-id">1493</journal-id>
<journal-id journal-id-type="nlm-ta">AIDS</journal-id>
<journal-id journal-id-type="iso-abbrev">AIDS</journal-id>
<journal-title-group><journal-title>AIDS (London, England)</journal-title>
</journal-title-group>
<issn pub-type="ppub">0269-9370</issn>
<issn pub-type="epub">1473-5571</issn>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">26193705</article-id>
<article-id pub-id-type="pmc">4833198</article-id>
<article-id pub-id-type="doi">10.1097/QAD.0000000000000749</article-id>
<article-id pub-id-type="manuscript">EMS67330</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>SINGLE DOSE NEVIRAPINE EXPOSURE DOES NOT AFFECT RESPONSE TO ANTI-RETROVIRAL THERAPY IN HIV-INFECTED AFRICAN CHILDREN AGED <3 YEARS</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" equal-contrib="yes"><name><surname>MUSOKE</surname>
<given-names>Philippa</given-names>
</name>
<aff id="A1">Baylor-Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital, Kampala, Uganda; Makerere University College of Health Sciences, Kampala, Uganda</aff>
</contrib>
<contrib contrib-type="author" equal-contrib="yes"><name><surname>SZUBERT</surname>
<given-names>Alexander J</given-names>
</name>
<aff id="A2">MRC Clinical Trials Unit at University College London, London, UK</aff>
</contrib>
<contrib contrib-type="author"><name><surname>MUSIIME</surname>
<given-names>Victor</given-names>
</name>
<aff id="A3">Joint Clinical Research Centre, Kampala, Uganda; Makerere University College of Health Sciences, Kampala, Uganda</aff>
</contrib>
<contrib contrib-type="author"><name><surname>NATHOO</surname>
<given-names>Kusum</given-names>
</name>
<aff id="A4">University of Zimbabwe College of Health Sciences, Harare, Zimbabwe</aff>
</contrib>
<contrib contrib-type="author"><name><surname>NAHIRYA-NTEGE</surname>
<given-names>Patricia</given-names>
</name>
<aff id="A5">Medical Research Council/Uganda Virus Research Institute Uganda Research Unit on AIDS, Entebbe, Uganda</aff>
</contrib>
<contrib contrib-type="author"><name><surname>MUTASA</surname>
<given-names>Kuda</given-names>
</name>
<aff id="A6">Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe</aff>
</contrib>
<contrib contrib-type="author"><name><surname>WILLIAMS</surname>
<given-names>David Eram</given-names>
</name>
<aff id="A7">Joint Clinical Research Centre, Kampala, Uganda</aff>
</contrib>
<contrib contrib-type="author"><name><surname>PRENDERGAST</surname>
<given-names>Andrew J.</given-names>
</name>
<aff id="A8">Queen Mary University of London, London, UK</aff>
</contrib>
<contrib contrib-type="author"><name><surname>SPYER</surname>
<given-names>Moira</given-names>
</name>
<aff id="A9">MRC Clinical Trials Unit at University College London, London, UK</aff>
</contrib>
<contrib contrib-type="author"><name><surname>WALKER</surname>
<given-names>A Sarah</given-names>
</name>
<aff id="A10">MRC Clinical Trials Unit at University College London, London, UK</aff>
<xref ref-type="author-notes" rid="FN3">##</xref>
</contrib>
<contrib contrib-type="author"><name><surname>GIBB</surname>
<given-names>Diana M</given-names>
</name>
<aff id="A11">MRC Clinical Trials Unit at University College London, London, UK</aff>
<xref ref-type="author-notes" rid="FN3">##</xref>
</contrib>
<contrib contrib-type="author"><collab>ARROW Trial Team</collab>
</contrib>
</contrib-group>
<author-notes><corresp id="CR1">Corresponding author: Alexander J Szubert, MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 125 Kingsway, London, WC2B 6NH, UK. Tel +44 (0) 20 7670 4746. Fax +44 (0) 20 7670 4814. <email>a.szubert@ucl.ac.uk</email>
</corresp>
<fn id="FN3"><label>##</label>
<p id="P42">equal contribution.</p>
</fn>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>3</day>
<month>3</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="ppub"><day>24</day>
<month>8</month>
<year>2015</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>15</day>
<month>4</month>
<year>2016</year>
</pub-date>
<volume>29</volume>
<issue>13</issue>
<fpage>1623</fpage>
<lpage>1632</lpage>
<pmc-comment>elocation-id from pubmed: 10.1097/QAD.0000000000000749</pmc-comment>
<abstract><sec id="S1"><title>Objectives</title>
<p id="P4">To assess the impact of exposure to single-dose nevirapine (sdNVP) on virological response in young Ugandan/Zimbabwean children (<3 years) initiating antiretroviral therapy (ART), and investigate other predictors of response.</p>
</sec>
<sec id="S2"><title>Design</title>
<p id="P5">Observational analysis within the ARROW randomised trial.</p>
</sec>
<sec id="S3"><title>Methods</title>
<p id="P6">sdNVP exposure was ascertained by caregiver’s self-report when the child initiated NNRTI based ART. Viral load (VL) was assayed retrospectively over median 4.1 years follow-up. Multivariable logistic regression models were used to identify independent predictors of VL <80 copies/ml 48 and 144 weeks after ART initiation (backwards elimination, exit p=0.1).</p>
</sec>
<sec id="S4"><title>Results</title>
<p id="P7">Median (IQR) age at ART initiation was 17 (10-23) months in 78 sdNVP exposed children versus 21 (14-27) months in 289 non-exposed children (36% vs 20% <12 months). At week 48, 49/73 (67%) sdNVP exposed and 154/272 (57%) non-exposed children had VL<80 copies/ml (adjusted (a)OR=2.34 [1.26-4.34] p=0.007); 79% and 77% had VL<400copies/ml. Suppression was significantly lower in males (p=0.009), those with higher pre-ART VL (p=0.001), taking syrups (p=0.05) and with lower self-reported adherence (p=0.04). At week 144, 55/73 (75%) exposed and 188/272 (69%) non-exposed had <80 copies/ml (aOR=1.75 [0.93-3.29] p=0.08). There was no difference between children with and without previous sdNVP exposure in intermediate/high-level resistance to NRTIs (p>0.3) or NNRTIs (p>0.1) (n=88) at week 144.</p>
</sec>
<sec id="S5"><title>Conclusion</title>
<p id="P8">Given the limited global availability of lopinavir/ritonavir, its significant formulation challenges in young children, and the significant paediatric treatment gap, tablet fixed-dose-combination nevirapine-based ART remains a good alternative to syrup lopinavir-based ART for children, particularly those over one year and even if exposed to sdNVP.</p>
</sec>
</abstract>
<kwd-group><kwd>HIV</kwd>
<kwd>Africa</kwd>
<kwd>children</kwd>
<kwd>antiretroviral therapy</kwd>
<kwd>viral load</kwd>
<kwd>sdNVP</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
<affiliations><list></list>
<tree><noCountry><name sortKey="Gibb, Diana M" sort="Gibb, Diana M" uniqKey="Gibb D" first="Diana M" last="Gibb">Diana M. Gibb</name>
<name sortKey="Musiime, Victor" sort="Musiime, Victor" uniqKey="Musiime V" first="Victor" last="Musiime">Victor Musiime</name>
<name sortKey="Musoke, Philippa" sort="Musoke, Philippa" uniqKey="Musoke P" first="Philippa" last="Musoke">Philippa Musoke</name>
<name sortKey="Mutasa, Kuda" sort="Mutasa, Kuda" uniqKey="Mutasa K" first="Kuda" last="Mutasa">Kuda Mutasa</name>
<name sortKey="Nahirya Ntege, Patricia" sort="Nahirya Ntege, Patricia" uniqKey="Nahirya Ntege P" first="Patricia" last="Nahirya-Ntege">Patricia Nahirya-Ntege</name>
<name sortKey="Nathoo, Kusum" sort="Nathoo, Kusum" uniqKey="Nathoo K" first="Kusum" last="Nathoo">Kusum Nathoo</name>
<name sortKey="Prendergast, Andrew J" sort="Prendergast, Andrew J" uniqKey="Prendergast A" first="Andrew J." last="Prendergast">Andrew J. Prendergast</name>
<name sortKey="Spyer, Moira" sort="Spyer, Moira" uniqKey="Spyer M" first="Moira" last="Spyer">Moira Spyer</name>
<name sortKey="Szubert, Alexander J" sort="Szubert, Alexander J" uniqKey="Szubert A" first="Alexander J" last="Szubert">Alexander J. Szubert</name>
<name sortKey="Walker, A Sarah" sort="Walker, A Sarah" uniqKey="Walker A" first="A Sarah" last="Walker">A Sarah Walker</name>
<name sortKey="Williams, David Eram" sort="Williams, David Eram" uniqKey="Williams D" first="David Eram" last="Williams">David Eram Williams</name>
</noCountry>
</tree>
</affiliations>
</record>
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