A randomized trial of consensus interferon in combination with ribavirin as initial treatment for chronic hepatitis C.
OBJECTIVE
The aim of the present, open-labeled, randomized study was to determine the efficacy and safety of different doses of consensus interferon plus ribavirin in the initial treatment of chronic hepatitis C.


METHODS
One hundred and one genotype 2/3 patients were randomized to receive 9 mcg (group A, n=48) or 18 mcg (group B, n=53) of consensus interferon thrice weekly plus ribavirin (1000/1200 mg/daily) for 24 weeks and 92 genotype 1 patients to receive 9 mcg (group C, n=47) or 18 mcg (group D, n=45) of consensus interferon plus ribavirin for 48 weeks.


RESULTS
In an intention-to-treat analysis, the sustained virologic response at 24-week follow-up was 69% and 66% for group A and B (P=0.77) and 40% and 36% for group C and D (P=0.63). The overall sustained response was 67% and 38% in patients with genotype 2/3 and 1, respectively. Among genotype 1 patients the sustained virologic response was 39% and 41% for high or low baseline viremia levels.


CONCLUSIONS
Higher consensus interferon dose does not increase sustained virologic response. Naive genotype 1 patients may achieve significant response rate of approximately 40% if treated with 9 mcg of consensus interferon plus ribavirin for 48 weeks.
Fattovich
Giovanna
G
Servizio Autonomo Clinicizzato di Gastroenterologia, Università di Verona, Piazzale La Scuro 10, 37134 Verona, Italy. giovanna_fattovich@tin.it
Zagni
Irene
I
Minola
Eliseo
E
Felder
Martina
M
Rovere
Pierangelo
P
Carlotto
Antonio
A
Suppressa
Sergio
S
Miracolo
Anna
A
Paternoster
Claudio
C
Rizzo
Caterina
C
Rossini
Angelo
A
Benedetti
Paolo
P
Capanni
Marco
M
Ferrara
Chiara
C
Costa
Paolo
P
Bertin
Tosca
T
Pantalena
Maurizio
M
Lomonaco
Lorenzo
L
Scattolini
Chiara
C
Mazzella
Giuseppe
G
Giusti
Massimo
M
Boccia
Sergio
S
Milani
Stefano
S
Marin
Renato
R
Lisa Ribero
Maria
M
Tagger
Alessandro
A
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016898:Interferon-alpha; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000998:Antiviral Agents; D007370:Interferon Type I; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin; C050739:interferon alfacon-1