Is interferon-alpha therapy safe and effective for patients with chronic hepatitis C and inflammatory bowel disease? A case-control study

S. Bargiggia, D. Thorburn, A. Anderloni, S. Ardizzone, A. Giorgi, G. Bianchi Porro, F. Parente

Research output: Contribution to journalArticle

Abstract

Background: Hepatitis C virus infection is more common in patients with inflammatory bowel disease than in general population. Limited data are available as to the safety and efficacy of α-interferon therapy for chronic active hepatitis C in patients with concomitant inflammatory bowel disease. Aim: To evaluate the efficacy and safety of α-interferon monotherapy in patients with chronic active hepatitis C and inactive or mildly active inflammatory bowel disease. Methods: A total of 513 consecutive inflammatory bowel disease patients at a single centre were tested for antibodies to hepatitis C virus (anti-hepatitis C virus) between 1995 and 2000. Twenty-one patients had detectable anti-hepatitis C virus Ab and were hepatitis C virus-RNA positive with histologically proved chronic active hepatitis. Each of these patients, whose inflammatory bowel disease was in clinical remission or mildly active, was sex- and age-matched to three controls with similar histological grade and stage of chronic hepatitis C virus but without inflammatory bowel disease; and all were treated with human leucocyte α-interferon 6 million units given thrice weekly for 12 months. Responses to treatment were classified as follows: complete response - persistently normal alanine aminotransferase and viral clearance (hepatitis C virus-RNA-ve) at the end-of-treatment, incomplete response - alanine aminotransferase normalization without viral clearance (hepatitis C virus-RNA+ve), and sustained response - alanine aminotransferase normalization and hepatitis C virus clearance 12 months after the end-of-treatment. Results: Twenty-one patients with chronic active hepatitis C and inflammatory bowel disease (10 with Crohn's disease and 11 with ulcerative colitis) and 63 sex- and age-matched controls with chronic hepatitis C virus alone received α-interferon monotherapy. Response rates to interferon were similar for inflammatory bowel disease patients compared with controls [CR 42% vs. 35% and SR 24% vs. 18% (P, not significant), respectively]. None of the 21 inflammatory bowel disease patients had severe adverse effects and the mild ones observed were comparable with those seen in the control group. No patients developed an inflammatory bowel disease relapse during the interferon treatment period or in the 12 months thereafter. Conclusions: The biochemical and virological response to a 12-month human leucocyte α-interferon treatment in patients with chronic active hepatitis C are similar to that observed in matched controls with chronic hepatitis C virus without inflammatory bowel disease. Adverse effects are similar in both groups of patients and unrelated to the underlying inflammatory bowel condition. This provides hepatologists with evidence that α-interferon can be safely administered to patients with chronic hepatitis C virus and inflammatory bowel disease provided that the inflammatory bowel condition is in clinical remission.

Original languageEnglish
Pages (from-to)209-215
Number of pages7
JournalAlimentary Pharmacology and Therapeutics
Volume22
Issue number3
DOIs
Publication statusPublished - Aug 1 2005

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Chronic Hepatitis C
Inflammatory Bowel Diseases
Interferon-alpha
Case-Control Studies
Hepacivirus
Interferons
Chronic Hepatitis
Therapeutics
Alanine Transaminase
RNA
Safety
Hepatitis C Antibodies
Virus Diseases
Ulcerative Colitis
Crohn Disease

ASJC Scopus subject areas

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

Cite this

Is interferon-alpha therapy safe and effective for patients with chronic hepatitis C and inflammatory bowel disease? A case-control study. / Bargiggia, S.; Thorburn, D.; Anderloni, A.; Ardizzone, S.; Giorgi, A.; Porro, G. Bianchi; Parente, F.

In: Alimentary Pharmacology and Therapeutics, Vol. 22, No. 3, 01.08.2005, p. 209-215.

Research output: Contribution to journalArticle

Bargiggia, S. ; Thorburn, D. ; Anderloni, A. ; Ardizzone, S. ; Giorgi, A. ; Porro, G. Bianchi ; Parente, F. / Is interferon-alpha therapy safe and effective for patients with chronic hepatitis C and inflammatory bowel disease? A case-control study. In: Alimentary Pharmacology and Therapeutics. 2005 ; Vol. 22, No. 3. pp. 209-215.
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AU - Anderloni, A.

AU - Ardizzone, S.

AU - Giorgi, A.

AU - Porro, G. Bianchi

AU - Parente, F.

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N2 - Background: Hepatitis C virus infection is more common in patients with inflammatory bowel disease than in general population. Limited data are available as to the safety and efficacy of α-interferon therapy for chronic active hepatitis C in patients with concomitant inflammatory bowel disease. Aim: To evaluate the efficacy and safety of α-interferon monotherapy in patients with chronic active hepatitis C and inactive or mildly active inflammatory bowel disease. Methods: A total of 513 consecutive inflammatory bowel disease patients at a single centre were tested for antibodies to hepatitis C virus (anti-hepatitis C virus) between 1995 and 2000. Twenty-one patients had detectable anti-hepatitis C virus Ab and were hepatitis C virus-RNA positive with histologically proved chronic active hepatitis. Each of these patients, whose inflammatory bowel disease was in clinical remission or mildly active, was sex- and age-matched to three controls with similar histological grade and stage of chronic hepatitis C virus but without inflammatory bowel disease; and all were treated with human leucocyte α-interferon 6 million units given thrice weekly for 12 months. Responses to treatment were classified as follows: complete response - persistently normal alanine aminotransferase and viral clearance (hepatitis C virus-RNA-ve) at the end-of-treatment, incomplete response - alanine aminotransferase normalization without viral clearance (hepatitis C virus-RNA+ve), and sustained response - alanine aminotransferase normalization and hepatitis C virus clearance 12 months after the end-of-treatment. Results: Twenty-one patients with chronic active hepatitis C and inflammatory bowel disease (10 with Crohn's disease and 11 with ulcerative colitis) and 63 sex- and age-matched controls with chronic hepatitis C virus alone received α-interferon monotherapy. Response rates to interferon were similar for inflammatory bowel disease patients compared with controls [CR 42% vs. 35% and SR 24% vs. 18% (P, not significant), respectively]. None of the 21 inflammatory bowel disease patients had severe adverse effects and the mild ones observed were comparable with those seen in the control group. No patients developed an inflammatory bowel disease relapse during the interferon treatment period or in the 12 months thereafter. Conclusions: The biochemical and virological response to a 12-month human leucocyte α-interferon treatment in patients with chronic active hepatitis C are similar to that observed in matched controls with chronic hepatitis C virus without inflammatory bowel disease. Adverse effects are similar in both groups of patients and unrelated to the underlying inflammatory bowel condition. This provides hepatologists with evidence that α-interferon can be safely administered to patients with chronic hepatitis C virus and inflammatory bowel disease provided that the inflammatory bowel condition is in clinical remission.

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