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/rATV/rFPV.

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)