Efficacy and safety of switching from lopinavir/r (LPV/r) to atazanavir/r (ATV/r) in patients with virologic suppression receiving a LPV/r containing HAART: the ATAZIP study
Objectives: To compare the efficacy and safety of switching from LPV/r to ATV/r in suppressed patients versus continuing a LPV/r HAART.
Methods: Randomized, open-label 96 weeks trial including patients with virological suppression (< 200 copies/ml; >= 6 mo.) on a LPV/r containing HAART. Patients were randomized 1:1 to either continue LPV/r or switch to ATV/r. Patients with > 4 PI-associated mutations and/or failed to > 2 PI containing regimens were excluded. Primary end point: proportion of patients with treatment failure (ITT switching=failure) at 48 weeks. Virologic failure: two consecutive viral load > 200 copies/ml.
Results: 248 patients were assigned to continue LPV/r (n=127) or to switch to ATV/r (n=121). Baseline characteristics were balanced including age, sex, risk for HIV infection, liver enzymes, fasting lipid profile, time on prior ARV, previous exposure to PI-containing regimens and median CD4 (around 450 cells/mm3). 30% had available evidence of harboring 1 or more PI-associated mutations (with 10% showing at least 1 major mutation, IAS definition). Treatment failure occurred in 20.6% (26/127) in the LPV/r arm and in 17.4% (21/121) in the ATV/r arm (difference –3.1%; 95% CI from –13.6% to 8%). Virological failure occurred in 6.3% (8/127) in the LPV/r arm and in 5% (6/121) in the ATV/r arm (difference –1.3%; 95% CI from –7.7 to 4.8%). CD4 changes from baseline were similar in both arms (around 40 cells/mm3). Adverse events leading to study drug discontinuation was 5% in both arms. Fasting TG and total cholesterol decreased significantly in the ATV/r arm, -51 and -19 mg/dL, respectively. Changes in ALT/AST were similar in both arms and significant total bilirubin elevations were frequently seen in the ATV/r arm
Conclusions: Switching to ATV/r in virologically suppressed patients who were receiving a LPV/r containing HAART provided comparable efficacy and safety profile with improved lipid parameters.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
"MallolasJ., et al.
Efficacy and safety of switching from lopinavir/r (LPV/r) to atazanavir/r (ATV/r) in patients with virologic suppression receiving a LPV/r containing HAART: the ATAZIP study.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention: