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A multicenter, randomized, controlled trial of interferon alfacon-1 compared with alpha-2a-interferon in Chinese patients with chronic hepatitis C virus infection.

AbstractBACKGROUND:
Alpha-interferons are the accepted therapy for patients infected with chronic hepatitis C virus (HCV) in China. However, consensus interferon (CIFN) for HCV treatment is effective in patients with chronic hepatitis C from Western countries.
METHODS:
This randomized, controlled trial was conducted to determine the safety and efficacy of CIFN at two doses, and to compare it with alpha-2a-interferon (IFN-alpha-2a) in Chinese patients with chronic HCV. Interferon-naive patients with chronic HCV infection (n = 187) were randomly chosen to receive 15 microg CIFN or 9 microg or 3 MU IFN-alpha-2a subcutaneously, three times a week for 24 weeks, followed by a 24 week observation period. Efficacy was evaluated by the normalization of serum alanine aminotransferase (ALT) and the non-detectability disappearance of serum HCV-RNA by using reverse-transcription-polymerase chain reaction. The safety of CIFN was evaluated by recording the type and severity of adverse effects.
RESULTS:
The combined ALT and HCV-RNA end-of-treatment and sustained responses were observed to be greater for treatment with 15 microg CIFN (59.0% and 55.7%, respectively) compared to IFN alpha-2a (36.1% and 39.3%, respectively; P = 0.01 for the end-of-treatment, P = 0.07 for the sustained response). The combined ALT and HCV-RNA end-of-treatment and sustained responses for treatment with 9 microg CIFN (both 49.2%) were higher than those for IFN-alpha-2a (not statistically significant). Data were analyzed by using a logistic-multiple-variate regression model, which indicated that the higher IFN dose (15 microg or 9 microg CIFN vs 3 MU IFN-alpha-2a; P < 0.01) appeared to be associated with a better sustained response. The type, frequency and severity of adverse effects were comparable across treatment groups.
CONCLUSIONS:
Consensus interferon appears to be safe and effective at concentrations of 9 and 15 microg, but 15 microg CIFN may be more effective than 3 MU IFN-alpha-2a, without increased toxicity.
AuthorsG B Yao, X X Fu, G S Tian, D Z Xu, L J Hao, Y S Huangfu, C X Su
JournalJournal of gastroenterology and hepatology (J Gastroenterol Hepatol) Vol. 15 Issue 10 Pg. 1165-70 (Oct 2000) ISSN: 0815-9319 [Print] AUSTRALIA
PMID11106097 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antiviral Agents
  • Interferon Type I
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • interferon alfacon-1
  • interferon alfa-2a
  • Alanine Transaminase
Topics
  • Adolescent
  • Adult
  • Aged
  • Alanine Transaminase (blood)
  • Antiviral Agents (administration & dosage, adverse effects, therapeutic use)
  • China
  • Female
  • Hepacivirus (genetics)
  • Hepatitis C, Chronic (drug therapy)
  • Humans
  • Injections, Subcutaneous
  • Interferon Type I (administration & dosage, adverse effects, therapeutic use)
  • Interferon-alpha (administration & dosage, adverse effects, therapeutic use)
  • Logistic Models
  • Male
  • Middle Aged
  • RNA, Viral (analysis)
  • Recombinant Proteins
  • Reverse Transcriptase Polymerase Chain Reaction
  • Safety
  • Time Factors

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