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.

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Presentation 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/rATV/rFPV + RTV 100 mgFPV + RTV 200 mgDRV/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% SWIFT 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 W HIV+ adults On ABC/3TC + PI/r ≥ 3 months HIV-1 RNA < 200 c/mL ≥ 3 months No 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/mm 3, median 532 Lipid modifying agent 43%51% Discontinuation by W48 N = 17 (11%) For adverse event 73 For lack of efficacy 01 Consent withdrawal/Lost to follow-up/ Investigator discretion/Protocol violation/Pregnancy 5/4/0/1/04/5/3/0/1 Baseline characteristics and patient disposition SWIFT Study: Switch ABC/3TC to TDF/FTC SWIFT Campo R, CID 2013, Jan 29 (epub ahead of print)

95% CI of the difference: ; 11.2 HIV RNA < 200 c/mL at W48, ITT-TLOVRVirologic failure Confirmed HIV RNA ≥ 200 c/mL or last value ≥ 200 c/mL SWIFT Study: Switch ABC/3TC to TDF/FTC SWIFT TDF/FTC ABC/3TC 100 % p= /155 11/ TDF/FTC ABC/3TC 15 N Campo R, CID 2013, Jan 29 (epub ahead of print)

TDF/FTCABC/3TC Renal event 1*1** Death 12 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 m 2 ) Weeks p= TDF/FTC ABC/3TC SWIFT Study: Switch ABC/3TC to TDF/FTC SWIFT 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 SWIFT Total chol LDL-c HDL-c TG TDF/FTCABC/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] mg/dL Campo R, CID 2013, Jan 29 (epub ahead of print)