Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children

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dc.contributor.authorViolari, Avyen_ZA
dc.contributor.authorPaed, F. C.en_ZA
dc.contributor.authorLindsey, Jane C.en_ZA
dc.contributor.authorHughes, Michael D.en_ZA
dc.contributor.authorMujuru, Hilda A.en_ZA
dc.contributor.authorBarlow-Mosha, Lindaen_ZA
dc.contributor.authorKamthunzi, Portiaen_ZA
dc.contributor.authorChi, Benjamin H.en_ZA
dc.contributor.authorCotton, Mark F.en_ZA
dc.contributor.authorMoultrie, Harryen_ZA
dc.contributor.authorKhadse, Sandhyaen_ZA
dc.contributor.authorSchimana, Werneren_ZA
dc.contributor.authorBobat, Raziyaen_ZA
dc.contributor.authorPurdue, Lynetteen_ZA
dc.contributor.authorEshleman, Susan H.en_ZA
dc.contributor.authorAbrams, Elaine J.en_ZA
dc.contributor.authorMillar, Lindaen_ZA
dc.contributor.authorPetzold, Elizabethen_ZA
dc.contributor.authorMofenson, Lynne M.en_ZA
dc.contributor.authorJean-Philippe, Patricken_ZA
dc.contributor.authorPalumbo, Paulen_ZA
dc.date.accessioned2012-07-05T08:00:52Z
dc.date.available2012-07-05T08:00:52Z
dc.date.issued2012
dc.descriptionCITATION: Violari, A. et al. 2012. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. New England Journal of Medicine, 366:2380-2389, doi:10.1056/NEJMoa1113249.
dc.descriptionThe original publication is available at https://www.nejm.org
dc.description.abstractBACKGROUND: Nevirapine-based antiretroviral therapy is the predominant (and often the only) regimen available for children in resource-limited settings. Nevirapine resistance after exposure to the drug for prevention of maternal-to-child human immunodeficiency virus (HIV) transmission is common, a problem that has led to the recommendation of ritonavir-boosted lopinavir in such settings. Regardless of whether there has been prior exposure to nevirapine, the performance of nevirapine versus ritonavir-boosted lopinavir in young children has not been rigorously established. METHODS: In a randomized trial conducted in six African countries and India, we compared the initiation of HIV treatment with zidovudine, lamivudine, and either nevirapine or ritonavir-boosted lopinavir in HIV-infected children 2 to 36 months of age who had no prior exposure to nevirapine. The primary end point was virologic failure or discontinuation of treatment by study week 24. RESULTS: A total of 288 children were enrolled; the median percentage of CD4+ T cells was 15%, and the median plasma HIV type 1 (HIV-1) RNA level was 5.7 log 10 copies per milliliter. The percentage of children who reached the primary end point was significantly higher in the nevirapine group than in the ritonavir-boosted lopinavir group (40.8% vs. 19.3%; P<0.001). Among the nevirapine-treated children with virologic failure for whom data on resistance were available, more than half (19 of 32) had resistance at the time of virologic failure. In addition, the time to a protocol-defined toxicity end point was shorter in the nevirapine group (P = 0.04), as was the time to death (P = 0.06). CONCLUSIONS: Outcomes were superior with ritonavir-boosted lopinavir among young children with no prior exposure to nevirapine. Factors that may have contributed to the suboptimal results with nevirapine include elevated viral load at baseline, selection for nevirapine resistance, background regimen of nucleoside reverse-transcriptase inhibitors, and the standard ramp-up dosing strategy. The results of this trial present policymakers with difficult choices. (Funded by the National Institute of Allergy and Infectious Diseases and others; P1060 ClinicalTrials.gov number, NCT00307151.) Copyright © 2012 Massachusetts Medical Society. All rights reserved.
dc.description.sponsorshipNational Institute of Allergy and Infectious Diseases
dc.description.urihttps://www.nejm.org/doi/full/10.1056/NEJMoa1113249
dc.description.versionPublisher's version
dc.format.extent10 pages
dc.identifier.citationViolari, A. et al. 2012. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. New England Journal of Medicine, 366:2380-2389, doi:10.1056/NEJMoa1113249.
dc.identifier.issn1533-4406 (online)
dc.identifier.issn0028-4793 (print)
dc.identifier.otherdoi:10.1056/NEJMoa1113249
dc.identifier.urihttp://hdl.handle.net/10019.1/21570
dc.publisherMassachusetts Medical Society
dc.rights.holderMassachusetts Medical Society
dc.subjectHIV infectionsen_ZA
dc.subjectAntriretroviral agentsen_ZA
dc.subjectNevirapineen_ZA
dc.subjectRitonaviren_ZA
dc.subjectLopinaviren_ZA
dc.titleNevirapine versus ritonavir-boosted lopinavir for HIV-infected childrenen_ZA
dc.typeArticle
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