Background: To evaluate the efficacy of leukocyte interferon in previously
untreated patients with chronic hepatitis C. 97 patients were enrolled in a
prospective study in Finland with a stepped-cart management protocol. Meth
ods: The treatment was initiated with 3 million units of interferon-alpha s
ubcutaneously three times a week. At 3 months. if the serum alanine aminotr
ansferase was still abnormal, the dose was doubled. If serum hepatitis C vi
rus (MCV) RNA had turned negative at 6 months, the treatment was stopped, i
f it was still positive, treatment was continued for up to 12 months. All p
atients were followed up after treatment for 6 months. Altogether, 74 patie
nts completed the treatment and followup periods. Results: Of all the origi
nally enrolled patients 36% (35 of 97) achieved sustained virologic respons
e, defined as HCV RNA negativity 6 months after the end of treatment. The c
ommonest HCV genotype among these patients was 3a, and as many as 52% of su
ch patients achieved sustained virologic response. Thirty-two per cent of t
he patients had HCV genotype 1a, 1b, or a mixture of these; a sustained res
ponse was achieved in only 6% of such patients but in 50% of patients with
a non-1 genotype. Adverse effects caused treatment cessation for 10% of the
patients and IFN dose reduction for 20%. Conclusions: Monotherapy with hum
an leukocyte interferon resulted in sustained virologic response in 36% of
patients with chronic hepatitis C. In those infected with a HCV genotype ot
her than 1, the sustained virologic response rate was 50%.