1 / 8

Switch to ATV + r-containing regimen - SWAN - SLOAT

Switch to ATV + r-containing regimen - SWAN - SLOAT. SWAN Study: switch PI + r to ATV + r. Design. Randomisation 2: 1 Open-label. W48. 419 HIV+ patients On stable PI-based regimen ≥ 3 months (PI dosed at least bid and > 3 pills/day) No history of failure on PI therapy

phuc
Download Presentation

Switch to ATV + r-containing regimen - SWAN - SLOAT

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Switch to ATV + r-containing regimen • - SWAN • - SLOAT

  2. SWAN Study: switch PI+r to ATV+r • Design Randomisation 2: 1 Open-label W48 419 HIV+ patients On stable PI-based regimen ≥ 3 months (PI dosed at least bid and > 3 pills/day) No history of failure on PI therapy HIV RNA < 50 c/mL ≥ 3 months CD4 > 50/mm3 N = 278 N = 141 * ATV 400 mg, or ATV/r 300/100 mg if TDF part of NRTI backbone • Objective • Non inferiority in the proportion of patients with virologic rebound at W48(upper limit of the 95% CI for the difference = 12%, 90% power) • Virologic rebound: 2 consecutive HIV-1 RNA ≥ 50 c/mL on study, or last on-study HIV-1 RNA ≥ 50 c/mL followed by study discontinuation Gatell J, CID 2007;44:1484-92 SWAN

  3. PI use at screening was LPV/r: 37%, NFV: 33%, IDV/r: 10%, IDV: 8%, SQV/r: 6%, SQV: 3% TDF was part of the ARV regimen in 37 patients (9%) [26 in the ATV group] SWAN Study: switch PI+r to ATV+r Baseline characteristics and patient disposition Gatell J, CID 2007;44:1484-92 SWAN

  4. p = 0,004 40 34% 35 ATV group Comparator PI group 30 p < 0,001 25 22% p = 0,004 21% 20 p = 0,53 16% 15 11% 10 8% 7% 5% 5 0 19/278 22/141 12/150 8/76 7/128 14/65 59/278 48/141 Differenceestimate (95% CI) -8.8 (-14.8 ; -2.7) -2.5 (-10.4 ; 5.3) -16.1 (-25.4 ; -6.8) -12.8 (-21.7 ; -4.0) SWAN Study: switch PI+r to ATV+r Treatment failure Virologic rebound (HIV-1 RNA ≥ 50 c/mL) % Patients on PI/r at screening Patients on unboosted PI at screening All patients Gatell J, CID 2007;44:1484-92 SWAN

  5. Patients not experiencingtreatment failure,% Patients not experiencingvirologic rebound,% 100 100 80 80 60 60 40 40 Hazard Ratio estimate (95% CI):0.59 (0.40-0.87) ; p = 0.008 Hazard Ratio estimate (95% CI):0.42 (0.22-0.79) ; p = 0.007 20 20 0 Baseline 12 24 36 48 Baseline 12 24 36 48 Weeks Weeks SWAN Study: switch PI+r to ATV+r 278 258 240 231 143 ATV group 278 254 239 231 143 141 122 110 101 74 ComparatorPI group 141 121 110 101 74 ATV group Comparator PI group Gatell J, CID 2007;44:1484-92 SWAN

  6. SWAN Study: switch PI+r to ATV+r 9% 10 0 -1% -3% -3% -3% -5% -10 p = 0.62 -12% -15% -20 -18% p = 0.18 p < 0.001 p < 0.001 -30 -33% -40 p < 0.001 Mean changes from baseline in lipid parameters at W48 Fasting LDL-C TC HDL-C Fasting TG Non-HDL-C Mean mg/dL at baseline 123 135 212 220 50 50 203 201 162 171 Mean mg/dL at Week 48 108 133 181 216 51 49 137 215 132 168 ATV group Comparator PI group HDL-C,high density lipoprotein cholesterol ; LDL-C, low-density lipoprotein cholesterol ; PI, protease inhibitor ; TC, total cholesterol Gatell J, CID 2007;44:1484-92 SWAN

  7. SWAN Study: switch PI+r to ATV+r Adverse events by W48 • AST and ALT elevations were more frequent in patients with hepatitis co-infection Gatell J, CID 2007;44:1484-92 SWAN

  8. SWAN Study: switch PI+r to ATV+r • Conclusions • Switching to a simplified PI-based regimen containing ATV provided better maintenance of virologic suppression with lower rates of virologic rebound and treatment failure than those observed with continued, unmodified therapy • Safety and tolerability were similar in both groups • But lipid parameters improved in the ATV group • Hyperbilirubinemia was frequent on ATV Gatell J, CID 2007;44:1484-92 SWAN

More Related