Efficacy of high dose of recombinant alpha 2b interferon on long term response in chronic hepatitis C and cirrhosis: prospective randomized multicentre study.
OBJECTIVE
The long-term response to alpha-Interferon in HCV-related chronic liver diseases is disappointing. A randomized controlled trial was conducted to investigate: 1) if doubling the standard regimen of 3 MU recombinant alpha 2b-interferon thrice weekly for one year could improve the long-term response, and 2) the efficacy of these two schedules in cirrhotic patients.


METHODS
A series of 80 anti-HCV positive patients with biopsy proven liver disease (52 chronic hepatitis and 28 cirrhosis) were randomized to receive either 3 MU or 6 MU alpha 2b-interferon.


RESULTS
Based on "intention-to-treat analysis", 38% in the 3 MU group and 53% in the 6 MU group had end-of-treatment response. After 24 months, 18% had long-term response: 5% in 3 MU group and 30% in 6 MU group (p < 0.008). HCV genotype had no influence on the response rate. Thirty-eight percent of the cirrhotics treated with 6 MU had long-term response, while none of those treated with 3 MU had long-term response (difference 38%; 95% confidence internal 10%-67%; p = 0.03). At the end of treatment, 38% of patients lost HCV-RNA. After 24 months only 19% remained HCV-RNA negative: 12 patients (31%) in the 6 MU group and 2 (6%) in the 3 MU group (p < 0.05).


CONCLUSIONS
6 MU of alpha 2b-interferon thrice weekly for 12 months is significantly better than 3 MU in inducing a long-term response and permanent loss of HCV-RNA. This result is particularly striking in the subgroup of cirrhotics.
Ascione
A
A
Liver Pathophysiology Unit, A. Cardarelli Hospital, Napoli, Italy.
De Luca
M
M
Canestrini
C
C
Di Costanzo
G G
GG
Raimondo
G
G
Longo
G
G
Manns
M P
MP
Tillmann
H L
HL
Forte
G B
GB
Rocco
P
P
Biceglia
O
O
Faleo
D
D
Vinelli
F
F
Cela
E M
EM
Amitrano
L
L
Addario
L
L
Gigliotti
T
T
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000201:enzymology / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000998:Antiviral Agents; D007370:Interferon Type I; D012367:RNA, Viral; D011994:Recombinant Proteins; D000410:Alanine Transaminase