Interferon-alpha alone versus interferon-alpha plus ribavirin in patients with chronic hepatitis C not responding to previous interferon-alpha treatment
S. Tripi et al., Interferon-alpha alone versus interferon-alpha plus ribavirin in patients with chronic hepatitis C not responding to previous interferon-alpha treatment, BIODRUGS, 13(4), 2000, pp. 299-304
Objective: To study the effects of monotherapy with leucocyte interferon-al
pha (IFN alpha) versus IFN alpha + ribavirin in patients with chronic hepat
itis C who were nonresponders to previous courses of recombinant or lymphob
lastoid IFN alpha.
Design and setting: This was a nonblind randomised study of outpatients at
3 centres in Palermo, Sicily, Italy.
Patients and participants: We recruited 72 patients (48 males, 24 females),
mean age 48.8 +/- 6.6 years (range 31 to 63 years), with biopsy-proven chr
onic hepatitis C, predominantly genotype Ib.
Interventions: 24 patients (group A) received IFN alpha 6MU 3 times weekly
for 6 months, and 48 patients (group B) received IFN alpha 6MU 3 times week
ly + ribavirin 1200 mg/day for 6 months. ALT levels and adverse effects wer
e monitored monthly, and hepatitis C virus (HCV) RNA levels were measured a
t, study entry, at the end of treatment and after a S-month follow-up.
Results: At baseline all patients were HCV-RNA positive and had ALT levels
greater than twice normal. Mean post-treatment serum HCV-RNA levels were be
low baseline in group A, but the virus was eradicated in only 1 patient; 6
patients had normalised serum ALT levels. In group B at end of treatment, 1
2 patients were negative for HCV-RNA and serum ALT levels were normal in 18
. At follow-up, all group A patients had elevated ALT levels and positive H
CV-RNA. In group B, 3 patients were still negative for HCV-RNA and 3 had no
rmal ALT. In 4 patients in group B, therapy was suspended because of anaemi
a, depression and decrease in neutrophil count; a flu-like syndrome was rec
orded with no frequency difference between groups.
Conclusions: These results suggest that patients with chronic hepatitis C u
nresponsive to IFN alpha monotherapy could benefit from combination therapy
with IFN alpha + ribavirin.