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Peginterferon alpha-2b plus ribavirin for treatment of chronic hepatitis C with severe fibrosis: a multicentre randomized controlled trial comparing two doses of peginterferon alpha-2b.

Abstract
We compared sustained virological response (SVR) in chronic hepatitis C patients with severe fibrosis treated with pegylated interferon (Peg-IFN) alpha-2b 1.5 microg/kg/week or 0.75 microg/kg/week in combination with ribavirin 800 mg/day for 48 weeks. This was a multicentre randomized controlled study. SVR was observed in 44.5% (45/101) of patients treated with the standard dose of Peg-IFN and 37.2% (38/102) of patients treated with the low dose (NS). In patients with genotypes 1, 4 and 5, SVR was observed in 25.0% of patients who received the standard dose and 16.9% of patients who received the low dose of Peg-IFN (P = NS). In patients with genotypes 1, 4 and 5 and low viraemia, SVR was obtained in 27.3% of patients treated with the standard dose and 25.8% of patients treated with the low dose (P = NS). In the high-viraemia subgroup, SVR was obtained in 24.0% and 9.1% of patients, respectively. In patients with genotypes 2 and 3, SVR was similar in both groups (73.2%vs 73.0%). Thus, (1) patients with genotypes 2 and 3 and severe fibrosis can be treated with low dose of Peg-IFN and ribavirin, (2) this study suggests that patients with genotypes 1, 4 and 5 and high viraemia could receive a standard dose of Peg-IFN associated with ribavirin for 48 weeks, (3) side effects limit the efficacy of the treatment with standard dose of Peg-IFN in patients with genotypes 1, 4 and 5 and low viraemia, (4) more studies are needed for patients with genotype 2 or 3 to define the optimal duration (24 or 48 weeks) in patients with severe fibrosis.
AuthorsA Abergel, C Hezode, V Leroy, K Barange, J P Bronowicki, A Tran, L Alric, L Castera, P-H Bernard, C Henquell, H Lafeuille, S Ughetto, C Darcha, M Chevallier, N Martineau, S Dubost, K Randl, D Dhumeaux, G Bommelaer, C Bonny, French multicenter study group
JournalJournal of viral hepatitis (J Viral Hepat) Vol. 13 Issue 12 Pg. 811-20 (Dec 2006) ISSN: 1352-0504 [Print] England
PMID17109680 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • peginterferon alfa-2b
Topics
  • Adult
  • Aged
  • Antiviral Agents (administration & dosage, adverse effects)
  • Dose-Response Relationship, Drug
  • Female
  • Hepatitis C, Chronic (drug therapy, pathology, virology)
  • Humans
  • Interferon alpha-2
  • Interferon-alpha (administration & dosage, adverse effects)
  • Liver Cirrhosis (drug therapy, pathology, virology)
  • Male
  • Middle Aged
  • Patient Compliance
  • Polyethylene Glycols
  • Recombinant Proteins
  • Ribavirin (administration & dosage, adverse effects)

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