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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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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.
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
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
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
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.”
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.