The aim of this study was to evaluate the most appropriate therapeutic prot
ocol for patients with chronic hepatitis C not responding to a previous cou
rse of recombinant interferon alpha-2b (rIFN). Sixty patients were randomly
assigned to two groups of 30 subjects each: group A was treated with doubl
e dose of the same type of rIFN (6 MU t.i.w.) plus ribavirin for 6 months;
group B was treated with the same rIFN dose and duration as group A, but wi
thout ribavirin. An end of treatment complete response (ETCR) was defined a
s alanine transaminase (ALT) normalization with undetectable serum HCV-RNA
at the end of the treatment, while an end of treatment biochemical response
(ETBR) as ALT normalization with still detectable viraemia. The two groups
were homogeneous. The patients with ETCR or ETBR were than followed-up for
at least 1 year. A sustained biochemical response (SBR) was defined as the
persistence of normal ALT with still detectable viraemia after a 12-month
follow-up, and a sustained complete response (SCR) as the persistence of no
rmal ALT with undetectable viraemia. Side-effects were only observed in pat
ients treated with rIFN plus ribavirin: four cases (13%) discontinued the t
herapy owing to haemolytic anaemia. Combination therapy induced an ETCR in
11 patients (37%) and an ETBR in six (20%), while a SCR was observed in two
subjects (7%) and a SBR in four (13%). The use of a double dose of rIFN al
one obtained an ETCR in four cases (13%) and an ETBR in five (17%), with a
SCR in two (7%) and a SBR in three (10%). Hence, both combination therapy a
nd single treatment with higher rIFN doses were unable to show statisticall
y significant long-term benefits in patients with chronic hepatitis C resis
tant to a previous course of rIFN treatment.