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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

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.


Peginterferon alfa 2a ribavirin for chronic hcv treatment duration and ribavirin dose
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.


Peginterferon alfa 2a ribavirin for chronic hcv treatment duration and ribavirin dose1
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.


Peginterferon alfa 2a ribavirin for chronic hcv treatment duration and ribavirin dose2
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.


Peginterferon alfa 2a ribavirin for chronic hcv treatment duration and ribavirin dose3
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.


Peginterferon alfa 2a ribavirin for chronic hcv treatment duration and ribavirin dose4
Peginterferon alfa-2a + Ribavirin for Chronic HCVTreatment Duration and Ribavirin Dose

Source: Hadziyannis SJ, et. al. Ann Intern Med. 2004;140:346-55.


Duration and dose finding peginterferon alfa 2a ribavirin

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.