Clinical trial: interferon alpha-2b continuous long-term therapy vs. repeated 24-week cycles for re-treating chronic hepatitis C.

Journal Article (Journal Article;Multicenter Study)

BACKGROUND: Treatment options are limited for patients with hepatitis C virus who do not experience sustained viral eradication with pegylated interferon and ribavirin therapy. AIM: To compare, in an open-label, randomized study, long-term continuous interferon alpha-2b treatment with repeated 24-week courses in patients with chronic hepatitis C virus that relapsed after prior interferon monotherapy. METHODS: A total of 499 patients received 24 weeks of interferon alpha-2b, 3 MIU administered 3 TIW. Responders (normal alanine aminotransferase and negative hepatitis C virus -RNA, n = 244) were then randomized to continuous interferon therapy (1, 2 or 3 MIU TIW depending on response) or cyclical therapy (3 MIU TIW for 24 weeks per relapse). Mean Knodell inflammation (I + II + III) and necrosis (IV) scores at baseline vs. year 2 were compared. RESULTS: Patients receiving continuous low-dose therapy vs. cycled therapy had larger reductions in inflammation (-3.9 vs. -3.1) and fibrosis (-0.49 vs. -0.24). Among both groups, the mean change was -3.4 for inflammation and -0.36 for fibrosis. Overall, 73% (95% CI: 67-79) of patients experienced reduced inflammation and 28% (95% CI: 22-34) had reduced fibrosis. CONCLUSIONS: Our results suggest hepatitis C virus patients experiencing viral suppression during long-term maintenance therapy with interferon demonstrate histological improvement. Further prospective trials testing this hypothesis are in progress.

Full Text

Duke Authors

Cited Authors

  • McHutchison, JG; Patel, K; Schiff, ER; Gitlin, N; Mur, RE; Everson, GT; Carithers, RL; Davis, GL; Marcellin, P; Shiffman, ML; Harvey, J; Albrecht, JK; International Hepatitis Interventional Therapy Group,

Published Date

  • March 1, 2008

Published In

Volume / Issue

  • 27 / 5

Start / End Page

  • 422 - 432

PubMed ID

  • 18081733

Electronic International Standard Serial Number (EISSN)

  • 1365-2036

Digital Object Identifier (DOI)

  • 10.1111/j.1365-2036.2007.03590.x


  • eng

Conference Location

  • England