Improved sustained response following treatment of Chronic
Hepatitis C by gradual reduction in the Interferon dose
Authors: SHIFFMAN_ML, HOFMANN_CM, LUKETIC_VAC, SANYAL_AJ,
CONTOS_MJ, MILLS_AS, VIRGINIA COMMONWEALTH UNIV, MED COLL VIRGINIA,
HEPATOL SECT, BOX 980711, RICHMOND, VA 23298 VIRGINIA COMMONWEALTH
UNIV, MED COLL VIRGINIA, DIV SURG PATHOL, RICHMOND, VA 23298
Publication: HEPATOLOGY, 1996, Vol.24, No.1, pp.21-26
ABSTRACT:
Interferon (IFN) treatment of chronic hepatitis C virus (HCV) is
associated with a high rate of relapse, IFN is thought to exert its
effect against HCV via direct viral inhibition and immune
stimulation, We have hypothesized that relapse following
termination of therapy results from the sudden withdrawal of this
immune modulatory effect and that gradual reduction in the IFN dose
may decrease the incidence of relapse.
One hundred six patients with chronic HCV were enrolled into
this 24-month controlled, randomized prospective trial. All were
treated with 5 mU of interferon-alpha-2b three times a week for 6
months. Patients who achieved biochemical response were randomized
to either stop or taper IFN gradually at monthly intervals as
follows; 3 mU, 2 mU, 1 mU, and 0.5 mU (all three times a week), 0.5
mU twice weekly and then once weekly.
Liver histology was assessed by Knodell index and HCV RNA was
measured by a quantitative polymerase chain reaction BCR) assay, Of
the 92 patients who completed the initial 6 months of IFN
treatment, 47 (51%) achieved biochemical response, Twenty-one of
these patients were randomized to stop IFN treatment and 25 to
taper (1 drop-out), At randomization patients were well. matched
with respect to age, sex, race, serum alanine transaminase (ALT),
and liver histology, Biochemical relapse was observed in 19 of 21
(91%) patients who stopped IFN treatment compared with only 60% who
tapered (P = .04), Virological relapse occurred in 90% of patients
who stopped and only 48% of persons who tapered IFN therapy. At
completion of the 24-month study patients who achieved long-term
sustained biochemical response had a significantly lower mean
Knodell score (3.5 vs, 6.5) and a significantly greater number were
HCV RNA negative in serum (85% vs, 18%) compared with
relapsers.
We conclude that gradual reduction in IFN dose is associated
with a significantly higher rate of sustained response and
clearance of HCV RNA hom serum compared with abruptly stopping
treatment, This in turn is associated with a significant
improvement in hepatic histology supporting the premise that
response to IFN therapy can prevent progression to cirrhosis.
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