switch abc/3tc to tdf/ftc swift study. swift study: switch abc/3tc to tdf/ftc design campo r, cid...
TRANSCRIPT
Switch ABC/3TC to TDF/FTC
SWIFT Study
SWIFT Study: Switch ABC/3TC to TDF/FTC
Design
Campo R, CID 2013, Jan 29 (epub ahead of print)
LPV/r ATV/r FPV + RTV 100 mg FPV + RTV 200 mg DRV/r
TDF/FTC 48/311 (15%) 62/311 (20%) 22/311 (7%) 12/311 (4%) 9/311 (3%)
ABC/3TC 53/311 (17%) 60/311 (19%) 12/311 (4%) 19/311 (6%) 11/311 (4%)
PI/r at baseline
Objective– Primary endpoint : proportion of patients with HIV-1 RNA < 200 c/mL through W48
(TLOVR failure = virologic failure [confirmed RNA ≥ 200 c/mL or last value ≥ 200 c/mL], premature discontinuation, ARV modification) ; lower limit of the 95% CI for the difference = - 12%
SWIFTSWIFT
TDF/FTC + PI/r(N = 155)
ABC/3TC + PI/r(N = 156)
* Stratification by PI: 32% LPV/r vs 68% non-LPV/r
Randomisation*1 : 1
Open-label
Randomisation*1 : 1
Open-label
W48W48
311 HIV+ adultsOn ABC/3TC + PI/r ≥ 3 months
HIV-1 RNA < 200 c/mL ≥ 3 monthsNo prior resistance to study drugs
311 HIV+ adultsOn ABC/3TC + PI/r ≥ 3 months
HIV-1 RNA < 200 c/mL ≥ 3 monthsNo prior resistance to study drugs
TDF/FTC (N = 155)
ABC/3TC (N = 156)
Male 83% 86%
HIV RNA < 50 c/mL 90% 93%
HIV RNA ≥ 200 c/mL 2% 1%
CD4/mm3, median 532 532
Lipid modifying agent 43% 51%
Discontinuation by W48 N = 17 (11%) N = 17 (11%)
For adverse event 7 3
For lack of efficacy 0 1
Consent withdrawal/Lost to follow-up/ Investigator discretion/Protocol violation/Pregnancy
5/4/0/1/0 4/5/3/0/1
Baseline characteristics and patient disposition
SWIFT Study: Switch ABC/3TC to TDF/FTC
SWIFTSWIFT Campo R, CID 2013, Jan 29 (epub ahead of print)
95% CI of the difference: - 5.1 ; 11.2
HIV RNA < 200 c/mL at W48, ITT-TLOVR Virologic failure
Confirmed HIV RNA ≥ 200 c/mL or last value ≥ 200 c/mL
SWIFT Study: Switch ABC/3TC to TDF/FTC
SWIFTSWIFT
86 83
0
60
80
40
20
TDF/FTC ABC/3TC
100%
p=0.034
3/155
11/156
0
10
5
TDF/FTC ABC/3TC
15N
Campo R, CID 2013, Jan 29 (epub ahead of print)
TDF/FTC ABC/3TC
Renal event 1* 1**
Death 1 2
Other 5*** 0
Adverse event leading to study drug discontinuation
* Creatinine elevation** Renal failure/dehydration*** Multiple CNS symptoms and rash ; malaise and lower back pain ; sepsis ; rash ; decreased weight
eGFR (MDRD) (mL/min/1.73 m2)
Weeks
p=0.008
- 9.2- 4.2
0 4 12 24 36 480
20
40
60
80
100
120
TDF/FTCABC/3TC
SWIFT Study: Switch ABC/3TC to TDF/FTC
SWIFTSWIFT Campo R, CID 2013, Jan 29 (epub ahead of print)
Fasting Lipids: median change from baseline to W48, mg/dL [mmol/L]
* Wilcoxon rank-sum test
No significant difference between groups in total cholesterol/HDL-c ratio at W48
SWIFT Study: Switch ABC/3TC to TDF/FTC
SWIFTSWIFT
Total chol
LDL-c
HDL-c
TG
TDF/FTC ABC/3TC
p<0.001* p=0.007* p=0.26* p=0.074*
- 21 [- 0.54]
- 3 [- 0.08]
- 7 [- 0.18]
2 [0.05]
- 1 [- 0.03]- 0 [0.00]
- 18 [- 0.20]
- 9 [- 0.10]
- 5
- 10
5
0
- 15
- 20
- 25
mg/
dL
Campo R, CID 2013, Jan 29 (epub ahead of print)