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

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.
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.
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.
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
  • 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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research network!

Choose Username:
Verify Password: