Treatment of patients with chronic hepatitis C not responding to interferon with high-dose interferon alpha with or without ribavirin: final results of a prospective randomized trial. Austrian Hepatitis Study Group.
OBJECTIVE
To investigate the efficacy of high-dose interferon alpha (IFN-alpha) with or without ribavirin in interferon (IFN) non-responders.


METHODS
304 chronic hepatitis C patients received 5 MU IFN-alpha2b (IntronA, Schering-Plough, Kenilworth, NJ, USA) three times a week for 3 months. Non-responders were randomized either to continue with IFN (IFN 5 MU/TIW followed by 10 MU/TIW, each for 3 months) alone (group A: n = 76, m: f = 54: 22, age 45.7 +/- 12 years, 16% cirrhosis, alanine aminotransferase [ALT] 66 +/- 35 U/l) or in combination with ribavirin (approximately 14 mg/kg/day) (group B: n = 81, m: f = 57: 24, age 48.2 +/- 12 years, 17% cirrhosis, ALT 71 +/- 40 U/l). At the end of treatment, patients were followed for 6 months.


METHODS
Virological response at end of treatment and 6 months thereafter.


METHODS
University hospitals and tertiary referral centres.


RESULTS
At the end of treatment, eight (10.8%) and 25 (31.3%, P= 0.0066) patients were HCV-RNA negative, and 51 and 39 were HCV-RNA positive, in groups A and B, respectively. There were 17 drop-outs in each group. Six months after treatment, only one patient in group A (1.3%) and seven patients (8.6%, P= 0.06) in group B had normal ALT and undetectable serum HCV-RNA.


CONCLUSIONS
A combination of high-dose IFN with ribavirin induces a short-lasting complete response in about one-third of IFN-non-responders.
Ferenci
P
P
Department of Internal Medicine IV, University of Vienna, Austria. peter.ferenci@akh-wien.ac.at
Stauber
R
R
Steindl-Munda
P
P
Gschwantler
M
M
Fickert
P
P
Datz
C
C
Müller
C
C
Hackl
F
F
Rainer
W
W
Watkins-Riedel
T
T
Lin
W
W
Krejs
G J
GJ
Gangl
A
A
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D001483:Base Sequence; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D007372:Interferons / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D009934:Organization and Administration; D016133:Polymerase Chain Reaction; D011336:Probability; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis*; D012016:Reference Values; D012254:Ribavirin / Q000008:administration & dosage*; D017211:Treatment Failure; D016896:Treatment Outcome
D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D012254:Ribavirin; D007372:Interferons