Switching to Efavirenz Versus Remaining on Ritonavir-boosted Lopinavir in Human Immunodeficiency Virus-infected Children Exposed to Nevirapine: Long-term Outcomes of a Randomized Trial.
Identifieur interne : 004065 ( Ncbi/Merge ); précédent : 004064; suivant : 004066Switching to Efavirenz Versus Remaining on Ritonavir-boosted Lopinavir in Human Immunodeficiency Virus-infected Children Exposed to Nevirapine: Long-term Outcomes of a Randomized Trial.
Auteurs : Pamela M. Murnane [États-Unis] ; Renate Strehlau [Afrique du Sud] ; Stephanie Shiau [États-Unis] ; Faeezah Patel [Afrique du Sud] ; Ndileke Mbete [Afrique du Sud] ; Gillian Hunt [Afrique du Sud] ; Elaine J. Abrams [Afrique du Sud] ; Ashraf Coovadia [Afrique du Sud] ; Louise Kuhn [États-Unis]Source :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [ 1537-6591 ] ; 2017.
Abstract
We previously demonstrated the noninferiority of switching to efavirenz (EFV) versus remaining on ritonavir-boosted lopinavir (LPV/r) for virologic control in children infected with human immunodeficiency virus (HIV) and exposed to nevirapine (NVP) for prevention of mother-to-child transmission. Here we assess outcomes up to 4 years post-randomization.
DOI: 10.1093/cid/cix335
PubMed: 28419200
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Murnane</name><affiliation wicri:level="2"><nlm:affiliation>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York</wicri:cityArea></affiliation></author><author><name sortKey="Strehlau, Renate" sort="Strehlau, Renate" uniqKey="Strehlau R" first="Renate" last="Strehlau">Renate Strehlau</name><affiliation wicri:level="4"><nlm:affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg</wicri:regionArea><orgName type="university">Université du Witwatersrand</orgName><placeName><settlement type="city">Johannesbourg</settlement><region type="region" nuts="2">Gauteng</region></placeName></affiliation></author><author><name sortKey="Shiau, Stephanie" sort="Shiau, Stephanie" uniqKey="Shiau S" first="Stephanie" last="Shiau">Stephanie Shiau</name><affiliation wicri:level="2"><nlm:affiliation>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York</wicri:cityArea></affiliation></author><author><name sortKey="Patel, Faeezah" sort="Patel, Faeezah" uniqKey="Patel F" first="Faeezah" last="Patel">Faeezah Patel</name><affiliation wicri:level="4"><nlm:affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg</wicri:regionArea><orgName type="university">Université du Witwatersrand</orgName><placeName><settlement type="city">Johannesbourg</settlement><region type="region" nuts="2">Gauteng</region></placeName></affiliation></author><author><name sortKey="Mbete, Ndileke" sort="Mbete, Ndileke" uniqKey="Mbete N" first="Ndileke" last="Mbete">Ndileke Mbete</name><affiliation wicri:level="4"><nlm:affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg</wicri:regionArea><orgName type="university">Université du Witwatersrand</orgName><placeName><settlement type="city">Johannesbourg</settlement><region type="region" nuts="2">Gauteng</region></placeName></affiliation></author><author><name sortKey="Hunt, Gillian" sort="Hunt, Gillian" uniqKey="Hunt G" first="Gillian" last="Hunt">Gillian Hunt</name><affiliation wicri:level="1"><nlm:affiliation>Centre for HIV and STIs, National Institute for Communicable Diseases, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Centre for HIV and STIs, National Institute for Communicable Diseases, Johannesburg</wicri:regionArea><wicri:noRegion>Johannesburg</wicri:noRegion></affiliation></author><author><name sortKey="Abrams, Elaine J" sort="Abrams, Elaine J" uniqKey="Abrams E" first="Elaine J" last="Abrams">Elaine J. Abrams</name><affiliation wicri:level="4"><nlm:affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg</wicri:regionArea><orgName type="university">Université du Witwatersrand</orgName><placeName><settlement type="city">Johannesbourg</settlement><region type="region" nuts="2">Gauteng</region></placeName></affiliation></author><author><name sortKey="Coovadia, Ashraf" sort="Coovadia, Ashraf" uniqKey="Coovadia A" first="Ashraf" last="Coovadia">Ashraf Coovadia</name><affiliation wicri:level="4"><nlm:affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg</wicri:regionArea><orgName type="university">Université du Witwatersrand</orgName><placeName><settlement type="city">Johannesbourg</settlement><region type="region" nuts="2">Gauteng</region></placeName></affiliation></author><author><name sortKey="Kuhn, Louise" sort="Kuhn, Louise" uniqKey="Kuhn L" first="Louise" last="Kuhn">Louise Kuhn</name><affiliation wicri:level="2"><nlm:affiliation>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York</wicri:cityArea></affiliation></author></analytic><series><title level="j">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</title><idno type="eISSN">1537-6591</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We previously demonstrated the noninferiority of switching to efavirenz (EFV) versus remaining on ritonavir-boosted lopinavir (LPV/r) for virologic control in children infected with human immunodeficiency virus (HIV) and exposed to nevirapine (NVP) for prevention of mother-to-child transmission. Here we assess outcomes up to 4 years post-randomization.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28419200</PMID><DateCreated><Year>2017</Year><Month>04</Month><Day>18</Day></DateCreated><DateRevised><Year>2017</Year><Month>08</Month><Day>25</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1537-6591</ISSN><JournalIssue CitedMedium="Internet"><Volume>65</Volume><Issue>3</Issue><PubDate><Year>2017</Year><Month>Aug</Month><Day>01</Day></PubDate></JournalIssue><Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title><ISOAbbreviation>Clin. Infect. Dis.</ISOAbbreviation></Journal><ArticleTitle>Switching to Efavirenz Versus Remaining on Ritonavir-boosted Lopinavir in Human Immunodeficiency Virus-infected Children Exposed to Nevirapine: Long-term Outcomes of a Randomized Trial.</ArticleTitle><Pagination><MedlinePgn>477-485</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/cid/cix335</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">We previously demonstrated the noninferiority of switching to efavirenz (EFV) versus remaining on ritonavir-boosted lopinavir (LPV/r) for virologic control in children infected with human immunodeficiency virus (HIV) and exposed to nevirapine (NVP) for prevention of mother-to-child transmission. Here we assess outcomes up to 4 years post-randomization.</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">From 2010-2013, 298 NVP-exposed HIV-infected children ≥3 years of age were randomized to switch to EFV or remain on LPV/r in Johannesburg, South Africa (Clinicaltrials.gov NCT01146873). After trial completion, participants were invited to enroll into observational follow-up. We compared HIV RNA levels, CD4 counts and percentages, lipids, and growth across groups through four years post-randomization.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">HIV RNA levels 51-1000 copies/mL were less frequently observed in the EFV group than the LPV/r group (odds ratio [OR] 0.67, 95% confidence interval [CI]: 0.51-0.88, P = .004), as was HIV RNA >1000 copies/mL (OR 0.52 95% CI: 0.28-0.98, P = .04). The probability of confirmed HIV RNA >1000 copies/mL by 48 months was 0.07 and 0.12 in the EFV and LPV/r groups, respectively (P = .21). Children randomized to EFV had a reduced risk of elevated total cholesterol (OR 0.45 95% CI: 0.27-0.75, P = .002) and a reduced risk of abnormal triglycerides (OR 0.42, 95% CI 0.29-0.62, P < .001).</AbstractText><AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">Our results indicate that the benefits of switching virologically suppressed NVP-exposed HIV-infected children ≥3 years of age from LPV/r to EFV are sustained long-term. This approach has several advantages, including improved palatability, reduced metabolic toxicity, simplified cotreatment for tuberculosis, and preservation of second line options.</AbstractText><AbstractText Label="Clinical Trials Registration" NlmCategory="UNASSIGNED">NCT01146873.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Murnane</LastName><ForeName>Pamela M</ForeName><Initials>PM</Initials><AffiliationInfo><Affiliation>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Strehlau</LastName><ForeName>Renate</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shiau</LastName><ForeName>Stephanie</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Faeezah</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mbete</LastName><ForeName>Ndileke</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hunt</LastName><ForeName>Gillian</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Centre for HIV and STIs, National Institute for Communicable Diseases, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abrams</LastName><ForeName>Elaine J</ForeName><Initials>EJ</Initials><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>ICAP, Mailman School of Public Health.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pediatrics, College of Physicians & Surgeons, Columbia University, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coovadia</LastName><ForeName>Ashraf</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kuhn</LastName><ForeName>Louise</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, New York.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Infect Dis</MedlineTA><NlmUniqueID>9203213</NlmUniqueID><ISSNLinking>1058-4838</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">HIV infections</Keyword><Keyword MajorTopicYN="N">antiretroviral therapy</Keyword><Keyword MajorTopicYN="N">efavirenz</Keyword><Keyword MajorTopicYN="N">lopinavir-ritonavir</Keyword><Keyword MajorTopicYN="N">pediatrics</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>01</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>04</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>4</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>4</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>4</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28419200</ArticleId><ArticleId IdType="pii">3737621</ArticleId><ArticleId IdType="doi">10.1093/cid/cix335</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Afrique du Sud</li><li>États-Unis</li></country><region><li>Gauteng</li><li>État de New York</li></region><settlement><li>Johannesbourg</li></settlement><orgName><li>Université du Witwatersrand</li></orgName></list><tree><country name="États-Unis"><region name="État de New York"><name sortKey="Murnane, Pamela M" sort="Murnane, Pamela M" uniqKey="Murnane P" first="Pamela M" last="Murnane">Pamela M. 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