A multicenter, randomized, controlled trial of interferon alfacon-1 compared with alpha-2a-interferon in Chinese patients with chronic hepatitis C virus infection.
BACKGROUND
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.
Yao
G B
GB
Shanghai Jin An Qu Central Hospital, China. GBYAO@81890.net
Fu
X X
XX
Tian
G S
GS
Xu
D Z
DZ
Hao
L J
LJ
Huangfu
Y S
YS
Su
C X
CX
D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D007370:Interferon Type I / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012449:Safety; D013997:Time Factors
D000998:Antiviral Agents; D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; C050739:interferon alfacon-1; D000410:Alanine Transaminase