G. Saracco et al., LONG-TERM FOLLOW-UP OF PATIENTS WITH CHRONIC HEPATITIS-C TREATED WITHDIFFERENT DOSES OF INTERFERON-ALPHA-2B, Hepatology, 18(6), 1993, pp. 1300-1305
Eighty patients with chronic hepatitis C who completed a previously re
ported randomized controlled trial on the efficacy of interferon-alpha
2b were followed up for at least 36 mo after therapy discontinuation.
Seventeen patients (21.2%) maintained normal ALT values throughout the
follow-up; 63 (78.8%) either did not normalize the levels of ALT or r
elapsed during the follow-up. A significantly greater proportion of pa
tients treated with 3 million units of interferon three times a week s
ubcutaneously for 48 wk were long-term responders compared with patien
ts treated for 24 wk. Sex, age, hepatitis C virus antibody status, sou
rce of infection and pretreatment levels of ALT were not predictive of
long-term response. Cirrhosis was found to be an unfavorable predicti
ve factor. After 3 yr of follow-up, clearance of viremia was observed
in 58.9% of the 17 long-term responders but in none of the nonresponde
rs (p = 0.002). E2-NS1 antibody tested negative in 88.2% of long-term
responders and in 14.3% of nonresponders (p = 0.001). Fifty-nine perce
nt of long-term responders tested negative for C100-NS4 antibody compa
red with 14.3% of nonresponders (p = 0.031). No significant change was
observed in other antibodies. Four long-term responders underwent liv
er biopsy 2 yr after discontinuation of therapy. All four patients had
normal liver histology compared with baseline assessment of chronic a
ctive hepatitis in three and chronic persistent hepatitis in the other
. Three of the four were negative for serum hepatitis C virus RNA.