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Published on 4 November 2013

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INCIVO data to be presented

 

 

Janssen Infectious Diseases-Diagnostics BVBA (Janssen) will present new data for INCIVO® (telaprevir) in combination with peginterferon alfa and ribavirin (PR) at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington DC, highlighting that earlier treatment improves patient outcomes.
In addition,Janssen will present data at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) 16th European Congress in Dublin, Ireland, highlighting significant economic benefits associated with the use of a telaprevir-based regimen in a French patient population.
To date more than 110,000 patients have been treated with a telaprevir-based regimen globally(1) and triple therapy including a protease inhibitor remains the standard of care for patients with genotype-1 chronic HCV. Janssen continues to undertake clinical studies with telaprevir to identify opportunities to serve specialised and hard-to-treat patients in need of new therapeutic options for HCV.
Earlier treatment improves outcomes
A retrospective analysis of 1642 patients who participated in the pivotal telaprevir phase 3 studies explored treatment response by disease stage. It found that the safety and efficacy of telaprevir varied by fibrosis stage, with F0–F1 and F2 patients (mild to moderate liver disease) demonstrating a similar outcome, and these patients were more likely to achieve a sustained viral response than patients with more advanced disease. The gain in efficacy of telaprevir for F2 over F3/F4 was unaccompanied by excess risk of adverse events.(2)
Cost-effectiveness data in French patient population
A Markov model analysis to be presented at ISPOR observes that treating F2 patients with telaprevir is expected to result in better clinical outcomes, and even though it may yield a higher cost compared to delaying treatment, it should be considered as an efficient choice by the French healthcare system based on its estimated incremental cost-effectiveness ratio of €37,197/QALY gained.(3) A further study showed that delaying treatment until new regimens become available is not the most efficient option for the French Healthcare system as the likely total costs incurred would be higher for the new regimen versus a triple therapy regimen with telaprevir, and may present a challenge to payers (ISPOR abstract ID: 44612).(4)
“Cost is a key factor in decision-making by healthcare providers across the globe and it is encouraging that we are able to show that early treatment with a telaprevir-based regimen can provide potential cost benefits to health authorities,” said Gaston Picchio, Hepatitis Disease Area Leader, Janssen. “With our continued efforts of studying the efficacy and safety of telaprevir, Janssen is demonstrating its commitment to addressing the unmet needs of patients in these HCV patient groups.”
Additional INCIVO® (telaprevir) data to be presented this week include:
  • Pre-treatment IP-10 levels and IL28B genotype as predictive markers for SVR in treatment-naïve patients with genotype 1 HCV infection treated with telaprevir/peginterferon/ribavirin in the OPTIMIZE study.(5) (Abstract ID: 1852; Session Title: HCV Therapeutics: Approved Agents; 5 November, 2013; 8:00)
  • Predictive factors of premature discontinuation of triple therapy in the international telaprevir early access program.(6) (Abstract ID: 1875; Session Title: HCV Therapeutics: Approved Agents; 5 November, 2013; 8:00)
  • Real-life data of telaprevir-based triple-therapy in patients with chronic hepatitis C GT1 in Germany – A 48 week interim analysis.(7) (Abstract ID: 1900; Session Title: HCV Therapeutics: Approved Agents; 5 November, 2013; 8:00)
  • Cost-effectiveness analysis of telaprevir triple therapy for treatment-naive patients with chronic hepatitis C on the combined efficacy data of the ADVANCE and OPTIMIZE studies.(8) (Abstract ID: 1915; Session Title: HCV Therapeutics: Approved Agents; 5 November, 2013; 8:00)
  • Telaprevir combination therapy in treatment-naïve and experienced patients co-infected with HCV and HIV.(9) (Abstract ID: 38; Session Title: Parallel 5: HCV Therapeutics: Real World Experience; 3 November, 2013; 15:15)
  • Efficacy and safety results of treatment of patients over 65 years old with genotype 1 Hepatitis C with severe fibrosis or compensated cirrhosis: the international telaprevir Early Access Program.(10) (Abstract ID: 1911; Session Title: HCV Therapeutics: Approved Agents; 5 November, 2013; 8:00)
  • Treatment of Hepatitis C genotype 1 patients with severe fibrosis or compensated cirrhosis: efficacy results to week 16 on 1587 patients from the international telaprevir Early Access Program.(11) (Abstract ID: 1873; Session Title: HCV Therapeutics: Approved Agents; 5 November, 2013; 8:00)
  • Management and outcomes of anemia in 1587 patients with Hepatitis C genotype 1 infection from the international telaprevir Early Access Program.(12) (Abstract ID: 1516; Session Title: HCV: Virology; 4 November, 2013; 8:00)
References
  1. Janssen data on file.
  2. Zeuzem S, deMasi R, Foster GR, et al. Telaprevir + peginterferon alfa-2a and ribavirin in treatment-naïve patients with genotype 1 HCV and mild to moderate liver disease. Hepatology 2013;58(Suppl.1):1129A (abstract 1908).
  3. Lee A, Granados D, Hulbert E, McGarry L, Fleischmann J. Cost effectiveness of early versus delayed hepatitis C virus (HCV) treatment with telaprevir/pegylated interferon alpha/ribavirin triple therapy in adults aged 40+ in France. To be presented at ISPOR 16th European Congress, Dublin,Ireland, 2-6 November 2013.
  4. Lee A, Granados D, Hulbert E, McGarry L, Fleischmann J. Cost-effectiveness of hepatitis C virus (HCV) treatment with telaprevir/pegylated interferon alpha/ribavirin triple therapy versus waiting for new regimens in France. To be presented at ISPOR 16th European Congress, Dublin,Ireland, 2-6 November 2013.
  5. Vilgen L, Dierynck I, Janssen K, et al. Pre-treatment IP-10 levels and IL28B genotype as predictive markers for SVR in treatment-naïve patients withgenotype 1 HCV infection treated with telaprevir/peginterferon/ribavirinin the OPTIMIZE study. Hepatology 2013;58(Suppl.1):1096A-7A (abstract 1852).
  6. Gaeta GB, Colombo M, Abrao Ferreira PR, et al. Predictive factors of premature discontinuation of triple therapy in the International Telaprevir Early Access Program. Hepatology 2013;58(Suppl.1):1110A (abstract 1875).
  7. Berg T, Buggisch P, Hueppe D, et al. Real-life data of telaprevir-based triple-therapy in patients with chronic hepatitis C GT1 in Germany – a 48 week interim analysis. Hepatology 2013;58(Suppl.1):1124A (abstract 1900).
  8. Buti M, Gros B, Oyaguez I, et al. Cost-effectiveness analysis of telaprevir triple therapy for treatment-naïve patients with chronic hepatitis C based on the combined efficacy data of the ADVANCE and OPTIMIZE studies. Hepatology 2013;58(Suppl.1):1133A (abstract 1915).
  9. Montes M, Nelson M, Girard M, et al. Telaprevir combination therapy in treatment-naïve and experienced patients co-infected with HCV and HIV. Hepatology 2013;58(Suppl.1):225A-6A (abstract 38).
  10. Moreno C, Wedemeyer H, Fenandez I, et al. Efficacy and safety results of treatment of patients over 65 years old with genotype 1 hepatitis C with severe fibrosis or compensated cirrhosis: the International Telaprevir Early Access Program. Hepatology 2013;58(Suppl.1):1130A-1A (abstract 1911).
  11. Abrao Ferreira PR, Colombo M, Urbanek P, et al. Treatment of hepatitis C genotype 1 patients with severe fibrosis or compensated cirrhosis: efficacy results to week 16 on 1587 patients from the International Telaprevir Early Access Program. Hepatology 2013;58(Suppl.1):1108A-9A (abstract 1873).
  12. Strasser SI, Wedemeyer H, Urbanek P, et al. Management and outcomes of anemia in 1587 patients with hepatitis C genotype 1 infection from the International Telaprevir Early Access Program. Hepatology 2013;58(Suppl.1):942A-3A (abstract 1516).


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