Antiretroviral treatment simplification with 3 NRTIs or 2 NRTIs plus nevirapine in HIV-1-infected patients treated with successful first-line HAART

Anna Bonjoch, Roger Paredes, Juan Galvez, Celia Miralles, Sebastia Videla, Eva Martínez, Jose Miranda, Jose Antonio Muñoz-Moreno, Javier De La Torre, Arturo Prieto, Consuelo Vilades, Bonaventura Clotet

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Abstract

Objectives: To assess the virologic noninferiority of an antiretroviral treatment simplification with coformulated zidovudine/lamivudine/abacavir (group 1) vs. coformulated zidovudine/lamivudine plus nevirapine (group 2) in HIV-1-infected patients receiving successful firstline highly active antiretroviral therapy. Methods: This is a prospective, multicenter, open-label, comparative, randomized, noninferiority study. A delta of 15% for differences in virologic suppression <200 copies/mL between groups was pre-specified with a 1-sided 0.025 significance level. Results: A total of 134 patients were included into this study: 68 were allocated to group 1 and 66 to group 2. By intention-to-treat analysis (switch equals failure), the percentage of virologic suppression <200 copies/mL (<50 copies/mL) at week 48 was 71.0% (65.1%) and 73.0% (63.3%) in groups 1 and 2, respectively (estimate for differences [<200 copies/mL]: -2.1, 95% CI: -17.4-13.1, P = 0.783). Thirteen and 14 patients in groups 1 and 2, respectively, discontinued therapy due to adverse events. Dyslipidemia improved in both groups, with a higher improvement in low-density lipoprotein cholesterol (P = 0.049) in group 1. Conclusions: Group 1 is not inferior to group 2 regarding virologic suppression <200 copies/mL. Both strategies improve lipid profile. Copyright © 2005 by Lippincott Williams & Wilkins.
Original languageEnglish
Pages (from-to)313-316
JournalJournal of Acquired Immune Deficiency Syndromes
Volume39
Issue number3
DOIs
Publication statusPublished - 1 Jul 2005

Keywords

  • Antiretroviral simplification
  • Coformulated zidovudine/ lamivudine/abacavir
  • Coformulated zidovudine/lamivudine
  • HIV-1
  • Nevirapine
  • Noninferiority study

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    Bonjoch, A., Paredes, R., Galvez, J., Miralles, C., Videla, S., Martínez, E., Miranda, J., Muñoz-Moreno, J. A., De La Torre, J., Prieto, A., Vilades, C., & Clotet, B. (2005). Antiretroviral treatment simplification with 3 NRTIs or 2 NRTIs plus nevirapine in HIV-1-infected patients treated with successful first-line HAART. Journal of Acquired Immune Deficiency Syndromes, 39(3), 313-316. https://doi.org/10.1097/01.qai.0000164249.33851.3a