Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin in GT 1-6 (Flat versus Weight-Based Ribavirin Dosing) WINR Study Phase 3 Treatment.

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Presentation transcript:

Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin in GT 1-6 (Flat versus Weight-Based Ribavirin Dosing) WINR Study Phase 3 Treatment Naïve, Chronic HCV Jacobson IM, et. al. Hepatology. 2007;46:

Hepatitis web study *Weight-based ribavirin dosing: kg: 1200 mg/d; >105 kg: 1400 mg/d Peginterferon alfa-2b + Ribavirin (weight-based or flat-dose) WIN-R Study: Design Study - Prospective, randomized, open-label trial Subjects - N = 5027 with chronic hepatitis C (4913 analyzed) - Treatment naïve adult patients (Age 18-70) Treatment Regimens - Peginterferon alfa-2b: 1.5 µg/kg/wk + Wt-based* Ribavirin: mg/d - Peginterferon alfa-2b: 1.5 µg/kg/wk + Flat-dose Ribavirin: 800 mg/d Treatment Duration - Genotypes 1,4,5,6: duration of 48 weeks - Genotypes 2,3: duration of 24 or 48 weeks Primary Endpoint - Undetectable serum HCV RNA at end of treatment (ETR) - Undetectable serum HCV RNA 24 weeks after cessation of treatment (SVR) Source: Jacobson IM, et. al. Hepatology. 2007;46:

Hepatitis web study PEG + Ribavirin (weight-based) (n = 2111) PEG + RBV (weight-based) (n = 333) 48720Week24 Source: Jacobson IM, et. al. Hepatology. 2007;46: Peginterferon alfa-2b + Ribavirin (weight-based or flat-dose) WIN-R Study: Design SVR24 GT 1-6 Drug Dosing Peginterferon alfa-2b: 180 µg once weekly Weight-based Ribavirin (in 2 divided doses): mg/d if kg; 1400 mg/d if >105 kg Flat-dose Ribavirin (in 2 divided doses): 800 mg/day GT 2, 3 PEG + Ribavirin (flat dose) (n = 335) PEG + Ribavirin (flat dose) ( n = 2144 ) SVR24

Hepatitis web study Peginterferon alfa-2b + Ribavirin (weight-based or flat-dose) WIN-R Study: Results SVR 24, by Genotype and Treatment Regimen Source: Jacobson IM, et. al. Hepatology. 2007;46: / / / / /775462/777 P =.008 P =.005 P =.252

Hepatitis web study P =.973 P =.001 Peginterferon alfa-2b + Ribavirin (weight-based or flat-dose) WIN-R Study: Results All Treated: SVR24 by Weight Distribution Source: Jacobson IM, et. al. Hepatology. 2007;46:

Hepatitis web study Peginterferon alfa-2b + Ribavirin (weight-based or flat-dose) WIN-R Study: Results Sustained Virologic Response (SVR) by Weight Distribution Source: Jacobson IM, et. al. Hepatology. 2007;46: P =.036 P =.446

Hepatitis web study Source: Jacobson IM, et. al. Hepatology. 2007;46: Peginterferon alfa-2b and Weight-based or Flat-dose Ribavirin WIN-R Study: Conclusions Conclusion: “Peginterferon alfa-2b plus weight-based ribavirin is more effective than flat-dose ribavirin, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups. Ribavirin 1400 mg/day is appropriate for patients 105 to 125 kg. For genotype 2/3 patients, 24 weeks of treatment with flat-dose ribavirin is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated.”

Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.