Similar Antiviral Efficacy and Tolerability Between Efavirenz and Lopinavir/Ritonavir, Administered With Abacavir/Lamivudine (Kivexa), in Antiretroviral-Na?ve Patients: A 48-Week, Multicentre, Randomized Study (Lake Study). -
Similar Antiviral Efficacy and Tolerability Between Efavirenz and Lopinavir/Ritonavir, Administered With Abacavir/Lamivudine (Kivexa), in Antiretroviral-Naïve Patients: A 48-Week, Multicentre, Randomized Study (Lake Study).
Antiviral Res. 2009 Nov 23;
Authors: Echeverría P, Negredo E, Carosi G, Gálvez J, Gómez JL, Ocampo A, Portilla J, Prieto A, López JC, Rubio R, Mariño A, Pedrol E, Viladés C, Del Arco A, Moreno A, Bravo I, López-Blazquez R, Pérez-Alvarez N, Clotet B
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((R)) (n=63) or lopinavir/r+Kivexa((R)) (n=63). Efficacy endpoints were the percentage of patients with HIV-RNA</=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 basis (ITT, 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=.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=.001; 249 cells in the lopinavir/r group, P=.002; P=.126 between groups). HDL cholesterol only increased in the efavirenz group (from 39mg/dL+/-12 to 49+/-11; P=.001). Discontinuations were more frequent in the lopinavir/r group (36.5% versus 28.5%; P=.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 were observed for efavirenz and lopinavir/r, when administered with Kivexa((R)) in antiretroviral-naive 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.
PMID: 19941906 [PubMed - as supplied by publisher] [PubMed-HIV]