Induction interferon and ribavirin for re-treatment of chronic hepatitis C patients unresponsive to interferon alone.
BACKGROUND
The optimal treatment for hepatitis C patients unresponsive to interferon is unclear. High-dose induction interferon may enhance early viral clearance, whilst ribavirin reduces relapse; in combination, they may improve sustained virological response rates.


OBJECTIVE
To compare the efficacy and safety of re-treatment with interferon induction, with or without ribavirin, in interferon non-responders.


METHODS
We randomized 218 biochemical interferon non-responders to 10 MU interferon alpha 2b daily for 4 weeks, followed by 5 MU thrice weekly for 48 weeks plus ribavirin (II + R), or to the same interferon regimen plus placebo (II + P). All patients were viraemic at entry.


RESULTS
The sustained virological response in the II + R group was 39%[95% confidence interval (CI), 30-48%], compared with 16% (95% CI, 9-23%) in the II + P group (P < 0.002). The study drug was discontinued for intolerable symptoms during induction in 9% of the II + R group and in 5% of the II + P group. By logistic regression, a sustained virological response was more likely following II + R treatment (odds ratio, 4.4; 95% CI, 2.1-9.7) and less likely in patients with genotype 1 or 4 (odds ratio, 0.16; 95% CI, 0.07-0.36).


CONCLUSIONS
High-dose induction interferon plus ribavirin is well tolerated and effective for patients unresponsive to interferon alone.
Sievert
W
W
Department of Medicine, Monash Medical Centre, Monash University, Melbourne, Clayton, VIC, Australia. William.Sievert@med.monash.edu.au
Batey
R
R
Mollison
L
L
Pianko
S
S
McDonald
J
J
Marinos
G
G
Reed
W
W
Warner
S
S
Bowden
S
S
De Solom
R
R
Bhathal
P
P
D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin