SPARE Study: Switching to DRV/r + RAL in HIV Patients
The SPARE study involved switching from LPV/r + TDF/FTC to RAL + DRV/r in HIV patients with preserved eGFR. Results showed no significant increase in renal function improvement but favorable viral efficacy. Limitations included a small sample size and self-reported adverse events in an open-label design.
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Switch to DRV/r + RAL SPARE Study
118 SPARE Study: switch to DRV/r + RAL Randomisation* 1 : 1 Open-label Design W96 Age 20 years HIV+ N = 28 DRV/r qd + RAL bid HIV-1 RNA < 50 c/ml > 15 weeks On LPV/r + TDF/FTC No prior virologic failure on PI/r- or INSTI-containing regimen eGFR (CG) > 60 mL/min HBs Ag negative Continuation of LPV/r + TDF/FTC N = 30 * Randomisation was stratified based on baseline body weight of 60 kg Objective Primary endpoint: proportion of patients with > 10% improvement in eGFR at 48 weeks from the baseline calculated with the CG equation Secondary endpoints: changes in per protocol renal tubular markers from baseline to week 48, proportions of patients with HIV-1 RNA < 50 c/mL at W24 and W48 (per protocol and ITT) Nishijima T. PLOS One 2013;8:e73639 SPARE
SPARE Study: switch to DRV/r + RAL Baseline characteristics (median), and disposition DRV/r + RAL N = 28 Continued LPV/r + TDF/FTC N = 30 Age, years 44 39 Female 0 3% CD4/mm3 549 456 eGFR (Cockroft-Gault), mL/min 119 108 Duration of TDF use, weeks 124 163 Discontinuation by W48 N = 4 N = 2 Nishijima T. PLOS One 2013;8:e73639 SPARE
SPARE Study: switch to DRV/r + RAL Endpoints by W48 DRV/r + RAL N = 28 Continued LPV/r + TDF/FTC N = 30 Primary endpoint : Improvement in eGFR > 10% increase in eGFR (CG formula) 6/24 3/28 (p = 0.27) Mean % improvement from baseline 5.4% - 3.3% Differences in mean % improvement (95% CI) - 8.7% (- 18.2 to 0.8) (p = 0.071) HIV RNA < 50 c/mL Per protocol W24 / W48 96.2% / 100% 96.7% / 100% ITT W24 / W48 89.3% / 85.7% 96.7% / 96.7% Safety, N Discontinuation for AE 2 0 Grade 3-4 laboratory abnormalities or symptoms 4 4 Nishijima T. PLOS One 2013;8:e73639 SPARE
SPARE Study: switch to DRV/r + RAL Conclusion Switching LPV/r + TDF/FTC to RAL+ DRV/r did not significantly increase the proportion of patients who showed >10% improvement in renal function among those with relatively preserved eGFR. However, the switch improved urinary 2 microglobulin, suggesting that discontinuation of TDF might be beneficial in the long-term RAL +DRV/r showed favorable viral efficacy in patients with suppressed viral load Limitations Small sample size Adverse events self-reported, open-label unblinded design Nishijima T. PLOS One 2013;8:e73639 SPARE
