Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children

Avy Violari, F. C. Paed, Jane C. Lindsey, Michael D. Hughes, Hilda A. Mujuru, Linda Barlow-Mosha, Portia Kamthunzi, Benjamin H. Chi, Mark F. Cotton, Harry Moultrie, Sandhya Khadse, Werner Schimana, Raziya Bobat, Lynette Purdue, Susan Eshleman, Elaine J. Abrams, Linda Millar, Elizabeth Petzold, Lynne M. Mofenson, Patrick Jean-PhilippePaul Palumbo

Research output: Contribution to journalArticle

Abstract

BACKGROUND: 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

Original languageEnglish (US)
Pages (from-to)2380-2389
Number of pages10
JournalNew England Journal of Medicine
Volume366
Issue number25
DOIs
StatePublished - Jun 21 2012

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Lopinavir
Nevirapine
Ritonavir
HIV
Lamivudine
Zidovudine
HIV-1
India
Therapeutics
Mothers
RNA
T-Lymphocytes

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Violari, A., Paed, F. C., Lindsey, J. C., Hughes, M. D., Mujuru, H. A., Barlow-Mosha, L., ... Palumbo, P. (2012). Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. New England Journal of Medicine, 366(25), 2380-2389. https://doi.org/10.1056/NEJMoa1113249

Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. / Violari, Avy; Paed, F. C.; Lindsey, Jane C.; Hughes, Michael D.; Mujuru, Hilda A.; Barlow-Mosha, Linda; Kamthunzi, Portia; Chi, Benjamin H.; Cotton, Mark F.; Moultrie, Harry; Khadse, Sandhya; Schimana, Werner; Bobat, Raziya; Purdue, Lynette; Eshleman, Susan; Abrams, Elaine J.; Millar, Linda; Petzold, Elizabeth; Mofenson, Lynne M.; Jean-Philippe, Patrick; Palumbo, Paul.

In: New England Journal of Medicine, Vol. 366, No. 25, 21.06.2012, p. 2380-2389.

Research output: Contribution to journalArticle

Violari, A, Paed, FC, Lindsey, JC, Hughes, MD, Mujuru, HA, Barlow-Mosha, L, Kamthunzi, P, Chi, BH, Cotton, MF, Moultrie, H, Khadse, S, Schimana, W, Bobat, R, Purdue, L, Eshleman, S, Abrams, EJ, Millar, L, Petzold, E, Mofenson, LM, Jean-Philippe, P & Palumbo, P 2012, 'Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children', New England Journal of Medicine, vol. 366, no. 25, pp. 2380-2389. https://doi.org/10.1056/NEJMoa1113249
Violari A, Paed FC, Lindsey JC, Hughes MD, Mujuru HA, Barlow-Mosha L et al. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. New England Journal of Medicine. 2012 Jun 21;366(25):2380-2389. https://doi.org/10.1056/NEJMoa1113249
Violari, Avy ; Paed, F. C. ; Lindsey, Jane C. ; Hughes, Michael D. ; Mujuru, Hilda A. ; Barlow-Mosha, Linda ; Kamthunzi, Portia ; Chi, Benjamin H. ; Cotton, Mark F. ; Moultrie, Harry ; Khadse, Sandhya ; Schimana, Werner ; Bobat, Raziya ; Purdue, Lynette ; Eshleman, Susan ; Abrams, Elaine J. ; Millar, Linda ; Petzold, Elizabeth ; Mofenson, Lynne M. ; Jean-Philippe, Patrick ; Palumbo, Paul. / Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. In: New England Journal of Medicine. 2012 ; Vol. 366, No. 25. pp. 2380-2389.
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AU - Violari, Avy

AU - Paed, F. C.

AU - Lindsey, Jane C.

AU - Hughes, Michael D.

AU - Mujuru, Hilda A.

AU - Barlow-Mosha, Linda

AU - Kamthunzi, Portia

AU - Chi, Benjamin H.

AU - Cotton, Mark F.

AU - Moultrie, Harry

AU - Khadse, Sandhya

AU - Schimana, Werner

AU - Bobat, Raziya

AU - Purdue, Lynette

AU - Eshleman, Susan

AU - Abrams, Elaine J.

AU - Millar, Linda

AU - Petzold, Elizabeth

AU - Mofenson, Lynne M.

AU - Jean-Philippe, Patrick

AU - Palumbo, Paul

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N2 - BACKGROUND: 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

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