hepatitis web study hepatitis web study interferon alfa-2b +/- ribavirin for 24 or 48 weeks phase 3...

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

Pat

ien

ts w

ith

SV

R 2

4 (%

)

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 Online

www.hepatitisc.uw.edu

Hepatitis Web Study

http://depts.washington.edu/hepstudy/

Funded by a grant from the Centers for Disease Control and Prevention.