SPARE Study SPARE Study switch to DRVr RAL Design Age 20 years HIV HIV1 RNA lt 50 cml gt 15 weeks On LPVr TDFFTC No prior virologic failure on PIr or INSTIcontaining regimen ID: 602065
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Slide1
Switch to DRV/r + RAL
SPARE
StudySlide2
SPARE Study: switch to DRV/r + RAL
Design
Age ≥
20
yearsHIV+HIV-1 RNA < 50 c/ml > 15 weeksOn LPV/r + TDF/FTCNo prior virologic failure on PI/r- or INSTI-containing regimeneGFR (CG) > 60 mL/min HBs Ag negative
DRV/r qd + RAL bid
Continuation of LPV/r + TDF/FTC
118
N = 28
N = 30
Randomisation*
1 : 1Open-label
W96
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
* Randomisation
was stratified based on baseline body weight of 60 kgSlide3
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/mm
3
549
456
eGFR
(
Cockroft-Gault
), mL/min
119
108
Duration of TDF use, weeks
163
124
Discontinuation by W48N = 4N = 2
SPARE Study: switch to DRV/r + RAL
Nishijima T. PLOS One 2013;8:e73639
SPARESlide4
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 symptoms44
Nishijima T. PLOS One 2013;8:e73639
SPARE
SPARE Study: switch to DRV/r + RAL Slide5
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 β2 microglobulin, suggesting that discontinuation of TDF might be beneficial in the long-termRAL +DRV/r showed favorable viral efficacy in patients with suppressed viral loadLimitationsSmall sample sizeAdverse events self-reported, open-label unblinded designNishijima T. PLOS One 2013;8:e73639
SPARE