SINGLE DOSE NEVIRAPINE EXPOSURE DOES NOT AFFECT RESPONSE TO ANTI-RETROVIRAL THERAPY IN HIV-INFECTED AFRICAN CHILDREN AGED <3 YEARS
Identifieur interne : 001419 ( Main/Exploration ); précédent : 001418; suivant : 001420SINGLE 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
Affiliations:
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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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<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>
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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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<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>
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<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>
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