1. Switch ABC/3TC to TDF/FTC
ARV-trial.com
Switch ABC/3TC to TDF/FTC
SWIFT Study 1

2. SWIFT Study: Switch ABC/3TC to TDF/FTC
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
W48
311 HIV+ adults
On ABC/3TC + PI/r ≥ 3 months
HIV-1 RNA < 200 c/mL ≥ 3 months
No prior resistance to study drugs
Design
PI/r at baseline
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%)
19/311 (6%)
11/311 (4%)
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%
SWIFT
Campo R, CID 2013, Jan 29 (epub ahead of print)

3. SWIFT Study: Switch ABC/3TC to TDF/FTC
Baseline characteristics and patient disposition
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
Lipid modifying agent
43%
51%
Discontinuation by W48
N = 17 (11%)
For adverse event 7 3
For lack of efficacy 1
Consent withdrawal/Lost to follow-up/ Investigator discretion/Protocol violation/Pregnancy
5/4/0/1/0
4/5/3/0/1
SWIFT
Campo R, CID 2013, Jan 29 (epub ahead of print)

4. SWIFT Study: Switch ABC/3TC to TDF/FTC
HIV RNA < 200 c/mL at W48, ITT-TLOVR
Virologic failure 86 83 60 80 40 20
TDF/FTC
ABC/3TC
100 %
p=0.034
3/155
11/156 10 5
TDF/FTC
ABC/3TC 15 N
95% CI of the difference: ; 11.2
Confirmed HIV RNA ≥ 200 c/mL or last value ≥ 200 c/mL
SWIFT
Campo R, CID 2013, Jan 29 (epub ahead of print)

5. SWIFT Study: Switch ABC/3TC to TDF/FTC
Adverse event leading to study drug discontinuation
TDF/FTC
ABC/3TC
Renal event 1*
1**
Death 1 2
Other
5***
* 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 4 12 24 36 48 20 40 60 80
100
120
TDF/FTC
ABC/3TC
SWIFT
Campo R, CID 2013, Jan 29 (epub ahead of print)

6. Fasting Lipids: median change from baseline to W48, mg/dL [mmol/L]
SWIFT Study: Switch ABC/3TC to TDF/FTC
Fasting Lipids: median change from baseline to W48, mg/dL [mmol/L]
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
- 15
- 20
- 25
mg/dL
No significant difference between groups in total cholesterol/HDL-c ratio at W48
* Wilcoxon rank-sum test
SWIFT
Campo R, CID 2013, Jan 29 (epub ahead of print)