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

Author(s): Bonjoch A, Paredes R, Galvez J, Miralles C, Videla S, Martinez E, Miranda J, Munoz-Moreno JA, De la Torre J, Prieto A, Vilades C, Clotet B, and the SimplifiHAART Study Group

Affiliation(s): AIDS Care Unit, Lluita contra le SIDA Foundation, Germans Trias i Pujol Hospital, Universitat Autonoma de Barcelona, Spain. abonjoch@ns.hugtip.scs.es

Publication date & source: 2005-07-01, J Acquir Immune Defic Syndr., 39(3):313-6.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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 first-line 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 prespecified 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.