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Duration and Dose Finding Peginterferon alfa-2a + Ribavirin

Phase 3. Treatment Naïve, Chronic HCV. Duration and Dose Finding Peginterferon alfa-2a + Ribavirin . Randomized study of low-dose versus weight based ribavirin and 24 versus 48 weeks of therapy. Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55. .

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Duration and Dose Finding Peginterferon alfa-2a + Ribavirin

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  1. Phase 3 TreatmentNaïve, Chronic HCV Duration and Dose Finding Peginterferon alfa-2a + Ribavirin Randomized study of low-dose versus weight based ribavirin and 24 versus 48 weeks of therapy Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55.

  2. Peginterferon alfa-2a + Ribavirin for Chronic HCVTreatment Duration and Ribavirin Dose • Study- Randomized, double-blind trial, with 2 x 2 factorial design • 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: 1000-1200 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: 1000-1200 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 (SVR) *Ribavirin dose: Ribavirin 1000 mg/day for Wt <75 kg, 1200 mg/day for Wt ≥75 kg Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55.

  3. Peginterferon alfa-2a + Ribavirin for Chronic HCVTreatment Duration and Ribavirin Dose Week 0 12 24 48 72 Randomize Peginterferon alfa-2a + Ribavirin (low dose) (n = 214) SVR24 Peginterferon alfa-2a + Ribavirin (weight-based dose)(n = 288) SVR24 Peginterferon alfa-2a + Ribavirin (low dose) (n = 365) SVR24 Peginterferon alfa-2a + Ribavirin (weight-based dose)(n = 444) SVR24 Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55.

  4. Peginterferon alfa-2a + Ribavirin for Chronic HCVTreatment Duration and Ribavirin Dose SVR24 Rates, by Regimen n = 101 n = 118 n = 250 n = 271 n = 96 n = 144 n = 99 n = 153 Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55.

  5. Peginterferon alfa-2a + Ribavirin for Chronic HCVTreatment Duration and Ribavirin Dose Rates of SVR with Different Peginterferon + Ribavivirn Regimens (≤ 2 x 106 copies/ml) (> 2 x 106 copies/ml) Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55.

  6. Peginterferon alfa-2a + Ribavirin for Chronic HCVTreatment Duration and Ribavirin Dose Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55.

  7. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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