SWAN Study: Switch to ATV-Containing Regimen in HIV Patients

The SWAN Study compared switching HIV patients from a protease inhibitor (PI)-based regimen to atazanavir (ATV)-containing regimens to evaluate non-inferiority in virologic rebound rates at week 48. The study showed lower virologic rebound rates in patients on ATV compared to PI, with higher efficacy in the ATV group. Patients not experiencing treatment failure also showed better outcomes with ATV. The study provides valuable insights into optimizing HIV treatment regimens to achieve better virologic control.

• SWAN Study
• HIV treatment
• ATV-containing regimen
• Virologic rebound
• Protease inhibitors

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1. Switch to ATV- or ATV/r-containing regimen Switch to ATV/r-containing regimen ATAZIP Switch to ATV r-containing regimen SWAN Study SLOAT Study Switch to ATV-containing regimen ARIES Study INDUMA Study ASSURE Study

2. SWAN Study: switch PI+r to ATV+r Design Randomisation 2: 1 Open-label W48 Switch to ATV+r qd* + continue other ARVs N = 278 419 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 Continue previous PI regimen + other ARVs 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. SWAN Study: switch PI+r to ATV+r Baseline characteristics and patient disposition ATV+r, N = 278 Comparator PI, N = 141 40 16% 27% 32% 3.4 41 21% 31% 31% 3.3 Median age, years Female History of AIDS diagnosis Hepatitis B and/or C co-infection Duration of prior PI treatment, mean years 1.69 1.69 HIV-1 RNA at randomisation (baseline), median log10c/mL 490 489 CD4 cell count at baseline, median/mm3 Discontinuation before W48, n (%) For adverse event For lack of efficacy 40 (14%) 17 1 27 (19%) 8 2 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] Gatell J, CID 2007;44:1484-92 SWAN

4. SWAN Study: switch PI+r to ATV+r Treatment failure Virologic rebound (HIV-1 RNA 50 c/mL) % p = 0,004 40 Patients on PI/r at screening Patients on unboosted PI at screening All patients 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 Difference estimate (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) Gatell J, CID 2007;44:1484-92 SWAN

5. SWAN Study: switch PI+r to ATV+r Patients not experiencing treatment failure,% Patients not experiencing virologic 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 278 141 258 122 240 110 231 101 143 74 ATV group Comparator PI group 278 141 254 121 239 110 231 101 143 74 ATV group Comparator PI group Gatell J, CID 2007;44:1484-92 SWAN

6. SWAN Study: switch PI+r to ATV+r Mean changes from baseline in lipid parameters at W48 Fasting LDL-C TC HDL-C Fasting TG Non-HDL-C 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 mg/dL at baseline Mean mg/dL at Week 48 123 108 135 133 212 181 220 216 50 51 50 49 203 137 201 215 162 132 171 168 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 ATV group Comparator PI 0 5 Death 27 (10%) 9 (6%) Serious adverse event 17 (6%) 8 (6%) Discontinuation because of adverse event 8 (3%) 0 Scleral icterus 7 (3%) 0 Jaundice 6 (2%) 2 (2%) Abdominal pain 12 (4%) 8 (6%) Grade 3-4 ALT elevation 7 (3%) 4 (3%) Grade 3-4 AST elevation 116 (43%) 4 (3%) Grade 3-4 total bilirubin elevation 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