Antiretroviral treatment for children with peripartum nevirapine exposure

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dc.contributor.authorPalumbo, P.
dc.contributor.authorLindsey, J. C.
dc.contributor.authorHughes, M. D.
dc.contributor.authorCotton, M. F.
dc.contributor.authorBobat, R.
dc.contributor.authorMeyers, T.
dc.contributor.authorBwakura-Dangarembizi, M.
dc.contributor.authorChi, B. H.
dc.contributor.authorMusoke, P.
dc.contributor.authorKamthunzi, P.
dc.contributor.authorSchimana, W.
dc.contributor.authorPurdue, L.
dc.contributor.authorEshleman, S. H.
dc.contributor.authorAbrams, E. J.
dc.contributor.authorMillar, L.
dc.contributor.authorPetzold, E.
dc.contributor.authorMofenson, L. M.
dc.contributor.authorJean-Philippe, P.
dc.contributor.authorViolari A.
dc.date.accessioned2011-05-15T16:17:30Z
dc.date.available2011-05-15T16:17:30Z
dc.date.issued2010
dc.description.abstractBackground: Single-dose nevirapine is the cornerstone of the regimen for prevention of mother-to-child transmission of human immunodeficiency virus (HIV) in resource-limited settings, but nevirapine frequently selects for resistant virus in mothers and children who become infected despite prophylaxis. The optimal antiretroviral treatment strategy for children who have had prior exposure to single-dose nevirapine is unknown. Methods: We conducted a randomized trial of initial therapy with zidovudine and lamivudine plus either nevirapine or ritonavir-boosted lopinavir in HIV-infected children 6 to 36 months of age, in six African countries, who qualified for treatment according to World Health Organization (WHO) criteria. Results are reported for the cohort that included children exposed to single-dose nevirapine prophylaxis. The primary end point was virologic failure or discontinuation of treatment by study week 24. Enrollment in this cohort was terminated early on the recommendation of the data and safety monitoring board. Results: A total of 164 children were enrolled. The median percentage of CD4+ lymphocytes was 19%; a total of 56% of the children had WHO stage 3 or 4 disease. More children in the nevirapine group than in the ritonavir-boosted lopinavir group reached a primary end point (39.6% vs. 21.7%; weighted difference, 18.6 percentage-points; 95% confidence interval, 3.7 to 33.6; nominal P = 0.02). Baseline resistance to nevirapine was detected in 18 of 148 children (12%) and was predictive of treatment failure. No significant between-group differences were seen in the rate of adverse events. Conclusions: Among children with prior exposure to single-dose nevirapine for perinatal prevention of HIV transmission, antiretroviral treatment consisting of zidovudine and lamivudine plus ritonavir-boosted lopinavir resulted in better outcomes than did treatment with zidovudine and lamivudine plus nevirapine. Since nevirapine is used for both treatment and perinatal prevention of HIV infection in resource-limited settings, alternative strategies for the prevention of HIV transmission from mother to child, as well as for the treatment of HIV infection, are urgently required. Copyright © 2010 Massachusetts Medical Society.
dc.description.versionArticle
dc.identifier.citationNew England Journal of Medicine
dc.identifier.citation363
dc.identifier.citation16
dc.identifier.issn00284793
dc.identifier.other10.1056/NEJMoa1000931
dc.identifier.urihttp://hdl.handle.net/10019.1/14247
dc.subjectlamivudine plus zidovudine
dc.subjectlopinavir plus ritonavir
dc.subjectnevirapine
dc.subjectarticle
dc.subjectCD4 lymphocyte count
dc.subjectchild
dc.subjectchild development
dc.subjectchild growth
dc.subjectclinical trial
dc.subjectcohort analysis
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdisease severity
dc.subjectdrug safety
dc.subjectdrug treatment failure
dc.subjectfemale
dc.subjectgene mutation
dc.subjectgenotype
dc.subjecthighly active antiretroviral therapy
dc.subjectHIV associated dementia
dc.subjecthuman
dc.subjectHuman immunodeficiency virus infection
dc.subjectimmune reconstitution inflammatory syndrome
dc.subjectinfant
dc.subjectinfection prevention
dc.subjectliver toxicity
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectoutcome assessment
dc.subjectperinatal drug exposure
dc.subjectprediction
dc.subjectpreschool child
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectside effect
dc.subjectsingle drug dose
dc.subjecttuberculosis
dc.subjectvertical transmission
dc.subjectAnti-HIV Agents
dc.subjectAnti-Retroviral Agents
dc.subjectChild, Preschool
dc.subjectDrug Therapy, Combination
dc.subjectFemale
dc.subjectHIV Infections
dc.subjectHIV-1
dc.subjectHumans
dc.subjectInfant
dc.subjectInfant, Newborn
dc.subjectInfectious Disease Transmission, Vertical
dc.subjectKaplan-Meiers Estimate
dc.subjectMale
dc.subjectNevirapine
dc.subjectPregnancy
dc.subjectPregnancy Complications, Infectious
dc.subjectPyrimidinones
dc.subjectRitonavir
dc.subjectRNA, Viral
dc.subjectTreatment Failure
dc.titleAntiretroviral treatment for children with peripartum nevirapine exposure
dc.typeArticle
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