Hepatitis web study Hepatitis web study Duration and Dose Finding Peginterferon alfa-2a + Ribavirin Phase 3 Treatment Naïve, Chronic HCV Randomized study.

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Presentation transcript:

Hepatitis web study Hepatitis web study Duration and Dose Finding Peginterferon alfa-2a + Ribavirin Phase 3 Treatment Naïve, Chronic HCV Randomized study of low-dose versus weight based ribavirin and 24 versus 48 weeks of therapy Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:

Hepatitis web study *Ribavirin dose: 1000 mg/day for Wt <75 kg, 1200 mg/day for Wt ≥75 kg Peginterferon alfa-2a + Ribavirin for Chronic HCV Treatment Duration and Ribavirin Dose Study - Randomized, double-blind trial Subjects - N = 1311 with chronic hepatitis C (1284 treated) - Treatment naïve adult patients; 58% genotype 1 - Serum ALT above upper limit of normal x prior 6 months Regimens - Peginterferon alfa-2a: 180 µg/wk + Ribavirin: 800 mg/day x 24 wks - Peginterferon alfa-2a: 180 µg/wk + *Ribavirin: mg/day x 24 wks - Peginterferon alfa-2a: 180 µg/wk + Ribavirin: 800 mg/d x 48 weeks - Peginterferon alfa-2a: 180 µg/wk + *Ribavirin: mg/day x 48 wks Primary Endpoint - Undetectable serum HCV RNA at end of treatment (ETR) - Undetectable serum HCV RNA 24 wks after cessation of treatment (SV Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:

Hepatitis web study Peginterferon alfa-2a + Ribavirin (low dose) (n = 214) Peginterferon alfa-2a + Ribavirin (low dose) (n = 365) Peginterferon alfa-2a + Ribavirin (weight-based dose) (n = 288) Peginterferon alfa-2a + Ribavirin (weight-based dose) (n = 158) Randomize Week 24 Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140: Peginterferon alfa-2a + Ribavirin for Chronic HCV Treatment Duration and Ribavirin Dose SVR24

Hepatitis web study Peginterferon alfa-2a + Ribavirin for Chronic HCV Treatment Duration and Ribavirin Dose SVR24 Rates, by Regimen Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140: n = 101n = 118n = 250n = 271n = 96n = 144n = 99n = 153

Hepatitis web study Peginterferon alfa-2a + Ribavirin for Chronic HCV Treatment Duration and Ribavirin Dose Rates of SVR with Different Peginterferon + Ribavirin Regimens Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:

Hepatitis web study Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140: Peginterferon alfa-2a + Ribavirin for Chronic HCV Treatment Duration and Ribavirin Dose Conclusion: “Treatment with peginterferon-alpha2a and ribavirin may be individualized by genotype. Patients with HCV genotype 1 require treatment for 48 weeks and a standard dose of ribavirin; those with HCV genotypes 2 or 3 seem to be adequately treated with a low dose of ribavirin for 24 weeks.”

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.