Retreatment of non-responder or relapser chronic hepatitis C patients with interferon plus ribavirin vs interferon alone.
OBJECTIVE
Interferon-alpha treatment of chronic hepatitis C is beneficial in only 20-30% of patients. This study evaluates if combination therapy with Interferon-alfa plus ribavirin is effective in inducing a response in patients who did not respond to, or relapsed after, a standard Interferon-alfa treatment.


METHODS
A total of 88 patients, 49 non-responders and 39 relapsers to previous Interferon-alfa therapy, were randomized to receive either natural Interferon-alfa (6 MU t.i.w.) plus ribavirin (1000 mg/daily) or natural Interferon-alfa alone (6 MU t.i.w.) for 6 months. All were followed for 12 months after stopping therapy. Serum aminotransferase levels were assessed monthly and HCV RNA was evaluated by RT-PCR (Amplicor, Roche) at end of therapy and the end of follow-up.


RESULTS
After treatment, a higher response rate defined as return to normal of aminotransferases and absence of serum HCV RNA was observed among patients treated with Interferon-alfa-ribavirin: 4/28 (14%) vs 1/21 (5%) non-responder patients and 9/19 (47%) vs 5/20 (25%) in the relapsers group. At the end of follow-up, a sustained response was found only in the combination treatment group: 4% and 32% in non-responder and relapser patients, respectively.


CONCLUSIONS
Our results suggest that retreatment with natural Interferon-alfa plus ribavirin is more effective than Interferon-alfa alone in increasing the response rate in patients with chronic hepatitis C who relapse after a previous standard IFN treatment whereas it is less effective in non-responder patients.
Milella
M
M
Clinic of Infectious Diseases, University of Bari, Italy.
Santantonio
T
T
Pietromatera
G
G
Maselli
R
R
Casalino
C
C
Mariano
N
N
Genchi
C
C
Pastore
G
G
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage*; D018709:Statistics, Nonparametric; D017211:Treatment Failure; D016896:Treatment Outcome
D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin