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Efficacy and safety of NRTI´s switch to tenofovir plus emtricitabine (Truvada(R)) vs. abacavir plus lamivudine (Kivexa(R)) in patients with virologic suppression receiving a lamivudine containing HAART: the BICOMBO study
Presented by Jose M Gatell, Spain.
Martinez E.1, Arranz J.A.2, Podzamczer D.3, Ribera E.4, Knobel H.5, Roca V.6, Gutierrez F.7, Llibre J.M.8, Barragan P.3, Clotet B.9, Dalmau D.10, Pich J.11, de Lazzari E.12, Gatell J.M.1
1Hospital Clinic Universitari, Infectious Diseases, Barcelona, Spain, 2Principe Asturias, Medicina, Oviedo, Spain, 3Bellvitge, Infectious Diseases, Barcelona, Spain, 4Vall d´Hebron, Infectious Diseases, Barcelona, Spain, 5Hospital del Mar, Infectious Diseases, Barcelona, Spain, 6Clinico San Carlos, Medicina, Madrid, Spain, 7Hospital de Elche, Medicina, Elche, Spain, 8Hospital Calella, Medicina, Calella, Spain, 9Fundacio IrsiCaixa, HIV, Barcelona, Spain, 10Mutua de Tarrasa, Medicina, Tarrasa, Spain, 11Hospital Clinic Universitari, Pharmacology, Barcelona, Spain, 12Hospital Clinic Universitari, Biostatistics, Barcelona, Spain
Objectives: To compare the efficacy and safety of Truvada® vs. Kivexa® in patients with virologic suppression.
Methods: Randomized, open-label trial with 333 suppressed patients (< 200 copies/ml; >= 6 mo.) on a lamivudine containing HAART assigned to switch their NRTI´s to Truvada® or Kivexa® . Primary end point was the proportion of patients with treatment failure (ITT switching=failure) at 48 weeks.
Results: Patients were assigned to Truvada® (n=166) or Kivexa® (n=167). Baseline characteristics were balanced including age, sex, risk for HIV , CD4+ count (around 520 in both arms), liver enzymes, fasting lipid profile, creatinine and GFR. Treatment failure occurred in 13.3% of patients (22 of 166) in the Truvada® arm and in 19.2% (32 of 167) in the Kivexa® arm (difference 5.9%; 95% CI –2.1, 14%). Virological failure occurred in no patient (0%) in the Truvada® arm and in 4 (2.4%) in the Kivexa® arm (difference 2.4%; 95% CI 0.05, 6%). CD4 increase was higher in the Kivexa® arm (+44 cells vs. –3 cells; p=0.03). AE´s leading to drug discontinuation developed in 5.4% in the Truvada® arm and in 10.2% in the Kivexa® arm (in 9 pts. due to suspected hypersensitivity to abacavir of whom 50% were HLA B57-01+). In the Truvada® arm median changes in fasting TG , total cholesterol and LDL were better (p<0.001) and worse for HDL ( p<0.001). Changes in creatinine and GFR were small and almost identical in both arms. Changes (dexa scan; n= 47) in total and limb fat (+164 mg Truvada® vs. +132 mg Kivexa® p=NS) and in bone mineral density were similar in both arms.
Conclusions: Switching the NRTI´s component to Kivexa® vs. Truvada® met non-inferiority criteria for virological efficacy but not for treatment efficacy. The difference was mainly driven by Kivexa® interruptions due to suspected abacavir hypersensitivy.
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