Sustained responses to interferon-alpha occur in 10% to 25% of patient
s with chronic hepatitis C, but the long-term outcome is not well defi
ned. We evaluated the long-term clinical, histological, and virologica
l outcomes of 10 patients with chronic hepatitis C who were treated be
tween 1984 and 1987 with interferon-alpha-2b for 52 +/- 6 weeks (total
doses of 492 +/- 116 MU), Before therapy, all 10 had hepatitis C viru
s (HCV) RNA, elevations of serum aminotransferases, and chronic hepati
tis with fibrosis on liver biopsy. Clinical follow up was 6 to 13 year
s, and liver biopsies were done 5 to 11 years after initiation of ther
apy, HCV RNA was assayed by qualitative and quantitative reverse trans
criptase-polymerase chain reaction assays, Among 5 patients who had a
6-month sustained response after therapy, all remained HCV RNA negativ
e, and at last follow-up, 4 had normal. and 1 minimally elevated serum
aminotransferase levels, Liver biopsy specimens were nonreactive for
HCV RNA, and all the patients showed improvements in both inflammation
and fibrosis and were either normal or had mild, nonspecific inflamma
tory changes. Among 5 patients without a sustained response, all conti
nued to have HCV RNA in serum and persistent or intermittent aminotran
sferase elevations. Liver biopsy specimens showed little or no change
in necrosis and inflammation; all except 1 patient had progression of
fibrosis scores or cirrhosis, All 5 patients had symptoms of chronic h
epatitis, 1 underwent liver transplantation, and another had progressi
ve hepatic decompensation. In conclusion, patients with a 6-month post
treatment virological response have a favorable long-term clinical and
histological outcome.