Simeprevir Treatment in HCV Genotype 1: ASPIRE Trial Results

The ASPIRE trial evaluated simeprevir treatment in patients with treatment-experienced chronic HCV genotype 1 infection. The study design included different dosing regimens of simeprevir with peginterferon and ribavirin, compared to placebo. Results showed varying sustained virologic response rates at different time points, with simeprevir combination therapies demonstrating improved efficacy compared to placebo. This trial provides valuable insights into treating HCV genotype 1 in patients who have previously failed peginterferon and ribavirin therapy.

• Simeprevir
• HCV Genotype 1
• ASPIRE Trial
• Chronic Hepatitis C
• Treatment

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1. Phase 3 Treatment Experienced Simeprevir in Treatment Experienced Genotype 1 ASPIRE Trial Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

2. Simeprevir in Treatment Experienced Genotype 1 HCV ASPIRE Trial: Features ASPIRE Trial: Study Features Design: Randomized, double-blind, placebo-controlled, 7 arm, phase 2b trial of PEG and RBV with and without simeprevir in HCV GT1 for prior treatment failures with PEG and RBV Setting: Europe, North America, Australia, and New Zealand Entry Criteria - Treatment-experienced, chronic HCV GT-1 monoinfection - Prior failure with ( 12 weeks) of peginterferon-alfa plus ribavirin - HCV RNA > 10,000 IU/mL Patient Characteristics - N = 462 - HCV Genotype: 1a (41%); 1b (58%); other (1%) - IL28B Genotype: 82% non-CC - Demographics: median age 50; 67% male; 93% white - Metavir Fibrosis: F3 = 19%; F4 = 18% Primary end-points: Efficacy (SVR24) Source: Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

3. Simeprevir in Treatment Experienced Genotype 1 HCV ASPIRE Trial: Design Week 0 12 24 48 72 Simeprevir 100 mg Peginterferon + Ribavirin Placebo n = 66 Simeprevir 150 mg Peginterferon + Ribavirin Placebo n = 66 Simeprevir 100 mg Peginterferon + Ribavirin Placebo n = 65 Simeprevir 150 mg Peginterferon + Ribavirin Placebo n = 68 Simeprevir 100 mg Peginterferon + Ribavirin n = 66 Simeprevir 150 mg Peginterferon + Ribavirin n = 65 Placebo Peginterferon + Ribavirin n = 66 Drug Dosing: Simeprevir: 100 or 150 mg once daily; Peginterferon alfa-2a (PEG): 180 mcg/week Ribavirin (RBV) weight-based (in 2 divided doses): 1000 mg if < 75kg or 1200 mg/day if 75kg Source: Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

4. Simeprevir in Treatment Experienced Genotype 1 HCV ASPIRE Trial: Results Week 0 12 24 48 72 Simeprevir 100 mg Peginterferon + Ribavirin Placebo SVR 24 = 70% n = 66 Simeprevir 150 mg Peginterferon + Ribavirin Placebo n = 66 SVR 24 = 62% Simeprevir 100 mg Peginterferon + Ribavirin Placebo SVR 24 = 66% n = 65 Simeprevir 150 mg Peginterferon + Ribavirin Placebo n = 68 SVR 24 = 72% Simeprevir 100 mg Peginterferon + Ribavirin SVR 24 = 61% n = 66 Simeprevir 150 mg Peginterferon + Ribavirin SVR 24 = 80% n = 65 Placebo Peginterferon + Ribavirin SVR 24 = 23% n = 66 Drug Dosing: Simeprevir: 100 or 150 mg once daily; Peginterferon alfa-2a (PEG): 180 mcg/week Ribavirin (RBV) weight-based (in 2 divided doses): 1000 mg if < 75kg or 1200 mg/day if 75kg Source: Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

5. Simeprevir in Treatment Experienced Genotype 1 HCV ASPIRE Trial: Results ASPIRE: SVR 24, by Treatment Regimen 100 80 80 72 Patients with SVR 24 (%) 70 67 66 61 60 40 23 20 46/66 43/65 40/66 44/66 49/68 52/65 15/66 0 SMV 12 wks PR 48 wks SMV 24 wks PR 48 wks SMV 48 wks PR 48 wks SMV 12 wks PR 48 wks SMV 24 wks PR 48 wks SMV 48 wks PR 48 wks Placebo PR 48 wks Simeprevir 100 mg Simeprevir 150 mg Placebo Source: Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

6. Simeprevir in Treatment Experienced Genotype 1 HCV ASPIRE Trial: Results ASPIRE: SVR 24, by Prior Treatment Response Placebo + PEG/RBV SMV 100 mg + PEG/RBV SMV 150 mg + PEG/RBV 100 85 85 Patients with SVR 24 (%) 80 75 57 60 51 46 37 40 19 46/66 43/65 40/66 44/66 49/68 52/65 15/66 20 9 0 Relapser Partial Responder Null Responder Source: Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

7. Simeprevir in Treatment Experienced Genotype 1 HCV ASPIRE Trial: Results ASPIRE: SVR 24, by Prior Treatment Response and GT 1 Subtype Placebo + PEG/RBV Simeprevir 100 mg + PEG/RBV Simprevir 150 mg + PEG/RBV 100 89 88 85 Patients with SVR 24 (%) 84 82 80 68 58 56 56 60 42 40 39 40 33 33 33 20 13 46/66 43/65 40/66 44/66 49/68 52/65 15/66 7 0 0 1a 1b 1a 1b 1a 1b Relapser Partial Responder Null Responder Source: Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

8. Simeprevir in Treatment Experienced Genotype 1 HCV ASPIRE Trial: Conclusions Conclusion: In treatment-experienced patients, 12, 24, or 48 weeks simeprevir (100 mg or 150 mg once daily) in combination with 48 weeks peginterferon and ribavirin significantly increased rates of SVR at 24 weeks compared with patients given placebo, peginterferon, and ribavirin, and was generally well tolerated. Source: Zeuzem S, et al. Gastroenterol. 2014;146:430-41.

9. This slide deck is from the University of Washingtons Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.