BACKGROUND: Although efavirenz and lopinavir/ritonavir(r) are both recommended antiretroviral agents in antiretroviral-naïve HIV-infected patients, there are few randomized comparisons of their efficacy and tolerability. METHODS: A multicenter and randomized study was performed including 126 antiretroviral-naïve patients, randomly assigned to efavirenz+Kivexa (n=63) or lopinavir/r+Kivexa (n=63). Efficacy endpoints were the percentage of patients with HIV-RNA < or =50 copies/mL at week 48 and CD4 recovery. Safety was assessed by comparing toxicity and discontinuations. Statistical analyses were performed on an intention-to-treat (ITT) basis (Missing=Failure). RESULTS: At week 48, 56.7% of patients in the efavirenz and 63.2% in the lopinavir/r groups showed HIV-1 RNA <50 copies/mL (P=0.770) (intention-to-treat analysis; Missing=Failure). Only 1 (1.53%) patient from each group experienced virological failure. CD4 values increased in both groups (298 cells in the efavirenz group, P=0.001; 249 cells in the lopinavir/r group, P=0.002; P=0.126 between groups). HDL-cholesterol only increased in the efavirenz group (from 39+/-12 mg/dL to 49+/-11; P=0.001). Discontinuations were more frequent in the lopinavir/r group (36.5% versus 28.5%; P=0.193), but more patients with efavirenz interrupted due to toxicity (11.1% versus 6.3%); most of them were attributed to hypersensitivity reaction. CONCLUSIONS: Similar virological efficacy was observed for efavirenz and lopinavir/r, when administered with Kivexa in antiretroviral-naïve patients, while immunological improvement was slightly superior for efavirenz. The higher rate of discontinuation due to toxicity in the efavirenz group was related to a higher incidence of hypersensitivity reaction. Nowadays, the use of the new formulation of lopinavir/r and the HLA-B*5701 genotype test before starting abacavir should improve the safety profiles of these regimens. Copyright 2009 Elsevier B.V. All rights reserved.
RCT Entities:
BACKGROUND: Although efavirenz and lopinavir/ritonavir(r) are both recommended antiretroviral agents in antiretroviral-naïve HIV-infectedpatients, there are few randomized comparisons of their efficacy and tolerability. METHODS: A multicenter and randomized study was performed including 126 antiretroviral-naïve patients, randomly assigned to efavirenz+Kivexa (n=63) or lopinavir/r+Kivexa (n=63). Efficacy endpoints were the percentage of patients with HIV-RNA < or =50 copies/mL at week 48 and CD4 recovery. Safety was assessed by comparing toxicity and discontinuations. Statistical analyses were performed on an intention-to-treat (ITT) basis (Missing=Failure). RESULTS: At week 48, 56.7% of patients in the efavirenz and 63.2% in the lopinavir/r groups showed HIV-1 RNA <50 copies/mL (P=0.770) (intention-to-treat analysis; Missing=Failure). Only 1 (1.53%) patient from each group experienced virological failure. CD4 values increased in both groups (298 cells in the efavirenz group, P=0.001; 249 cells in the lopinavir/r group, P=0.002; P=0.126 between groups). HDL-cholesterol only increased in the efavirenz group (from 39+/-12 mg/dL to 49+/-11; P=0.001). Discontinuations were more frequent in the lopinavir/r group (36.5% versus 28.5%; P=0.193), but more patients with efavirenz interrupted due to toxicity (11.1% versus 6.3%); most of them were attributed to hypersensitivity reaction. CONCLUSIONS: Similar virological efficacy was observed for efavirenz and lopinavir/r, when administered with Kivexa in antiretroviral-naïve patients, while immunological improvement was slightly superior for efavirenz. The higher rate of discontinuation due to toxicity in the efavirenz group was related to a higher incidence of hypersensitivity reaction. Nowadays, the use of the new formulation of lopinavir/r and the HLA-B*5701 genotype test before starting abacavir should improve the safety profiles of these regimens. Copyright 2009 Elsevier B.V. All rights reserved.
Authors: Berta Torres; Norma I Rallón; Montserrat Loncá; Alba Díaz; Llucia Alós; Esteban Martínez; Anna Cruceta; Joan Albert Arnaiz; Lorna Leal; Constanza Lucero; Agathe León; Marcelo Sánchez; Eugenia Negredo; Bonaventura Clotet; José M Gatell; José M Benito; Felipe Garcia Journal: AIDS Res Hum Retroviruses Date: 2014-02-10 Impact factor: 2.205
Authors: Álvaro H Borges; Andreas Lundh; Britta Tendal; John A Bartlett; Nathan Clumeck; Dominique Costagliola; Eric S Daar; Patrícia Echeverría; Magnus Gisslén; Tania B Huedo-Medina; Michael D Hughes; Katherine Huppler Hullsiek; Paul Khabo; Stephanus Komati; Princy Kumar; Shahin Lockman; Rodger D MacArthur; Franco Maggiolo; Alberto Matteelli; Jose M Miro; Shinichi Oka; Kathy Petoumenos; Rebekah L Puls; Sharon A Riddler; Paul E Sax; Juan Sierra-Madero; Carlo Torti; Jens D Lundgren Journal: Clin Infect Dis Date: 2016-04-18 Impact factor: 9.079
Authors: Yanink Caro-Vega; Pablo F Belaunzarán-Zamudio; Brenda E Crabtree-Ramírez; Bryan E Shepherd; Beatriz Grinsztejn; Marcelo Wolff; Jean W Pape; Denis Padgett; Eduardo Gotuzzo; Catherine C McGowan; Juan G Sierra-Madero Journal: Open Forum Infect Dis Date: 2018-03-02 Impact factor: 3.835