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Hepati tis web study Hepati tis web study Interferon alfa-2b +/- Ribavirin for 24 or 48 weeks Phase 3 Treatment Naïve, Chronic HCV McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.

I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

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Phase 3. Treatment Naïve, Chronic HCV. I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks. McHutchison JG, et al. N Engl J Med. 1998;339:1485-92. I nterferon alfa- 2b +/- Ribavirin for Chronic HCV Study Outline. - PowerPoint PPT Presentation

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Page 1: I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Hepatitisweb study

Hepatitisweb study

Interferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Phase 3

Treatment Naïve, Chronic HCV

McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.

Page 2: I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Hepatitisweb study

Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Outline

• Study- Randomized, double-blinded, placebo controlled, phase 3 trial- Conducted in 44 centers in United States

• Subjects- N = 912 with chronic hepatitis C - Treatment naïve; 72% genotype 1

• Regimens - Interferon alfa-2b + Placebo x 24 or 48 weeks - Interferon alfa-2b + Ribavirin (weight based) x 24 or 48 weeks

• Primary Endpoint- Undetectable serum HCV RNA 24 weeks after stopping treatment

Source: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.

*Ribavirin weight based dosing: <75 kg = 1000 mg/day; >75 kg = 1200 mg/day

Page 3: I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Hepatitisweb study

Interferon + Ribavirin(n = 228)

Interferon(n = 225)

Interferon (n = 231)

48 720Week

Source: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.

Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Design

Drug DosingInterferon alfa-2b 3 million U 3x/weekWeight-based Ribavirin (divided bid): 1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg

SVR24

Interferon + Ribavirin(n = 228)

SVR24

24

SVR24

SVR24

Page 4: I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Hepatitisweb study

Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Results

SVR 24, by Treatment Regimen

Source: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.

Interferon _x000d_(24 weeks)

Interferon _x000d_(48 weeks)

Interferon + Ribavirin _x000d_(24 weeks)

Interferon + Ribavirin _x000d_(48 weeks)

0

10

20

30

40

50

6

13

31

38

Patie

nts

with

SVR

24

(%)

13/231 29/225 70/228 87/228

Page 5: I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Hepatitisweb studySource: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.

Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Conclusions

Conclusions: “In patients with chronic hepatitis C, initial therapy with interferon and ribavirin was more effective than treatment with interferon alone.”

Page 6: I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Hepatitisweb study

Hepatitisweb study

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.