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

J. G. McHutchison, K. Patel, Eugene R Schiff, N. Gitlin, R. E. Mur, G. T. Everson, R. L. Carithers, G. L. Davis, P. Marcellin, M. L. Shiffman, J. Harvey, J. K. Albrecht

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Abstract

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.

Original languageEnglish
Pages (from-to)422-432
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume27
Issue number5
DOIs
StatePublished - Mar 1 2008

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interferon alfa-2b
Chronic Hepatitis C
Clinical Trials
Hepacivirus
Interferons
Inflammation
Fibrosis
Therapeutics
Ribavirin
Alanine Transaminase

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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Clinical trial : Interferon alpha-2b continuous long-term therapy vs. repeated 24-week cycles for re-treating chronic hepatitis C. / McHutchison, J. G.; Patel, K.; Schiff, Eugene R; Gitlin, N.; Mur, R. E.; Everson, G. T.; Carithers, R. L.; Davis, G. L.; Marcellin, P.; Shiffman, M. L.; Harvey, J.; Albrecht, J. K.

In: Alimentary Pharmacology and Therapeutics, Vol. 27, No. 5, 01.03.2008, p. 422-432.

Research output: Contribution to journalArticle

McHutchison, JG, Patel, K, Schiff, ER, Gitlin, N, Mur, RE, Everson, GT, Carithers, RL, Davis, GL, Marcellin, P, Shiffman, ML, Harvey, J & Albrecht, JK 2008, 'Clinical trial: Interferon alpha-2b continuous long-term therapy vs. repeated 24-week cycles for re-treating chronic hepatitis C', Alimentary Pharmacology and Therapeutics, vol. 27, no. 5, pp. 422-432. https://doi.org/10.1111/j.1365-2036.2007.03590.x
McHutchison, J. G. ; Patel, K. ; Schiff, Eugene R ; Gitlin, N. ; Mur, R. E. ; Everson, G. T. ; Carithers, R. L. ; Davis, G. L. ; Marcellin, P. ; Shiffman, M. L. ; Harvey, J. ; Albrecht, J. K. / Clinical trial : Interferon alpha-2b continuous long-term therapy vs. repeated 24-week cycles for re-treating chronic hepatitis C. In: Alimentary Pharmacology and Therapeutics. 2008 ; Vol. 27, No. 5. pp. 422-432.
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AU - McHutchison, J. G.

AU - Patel, K.

AU - Schiff, Eugene R

AU - Gitlin, N.

AU - Mur, R. E.

AU - Everson, G. T.

AU - Carithers, R. L.

AU - Davis, G. L.

AU - Marcellin, P.

AU - Shiffman, M. L.

AU - Harvey, J.

AU - Albrecht, J. K.

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N2 - 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.

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