August 23, 1996
Therapy (HCV); "Improved Sustained Response Following Treatment
of Chronic Hepatitis C by Gradual Reduction in the Interferon
Dose."
Hepatitis Weekly via Individual Inc.
According to the authors' abstract of an article published in
Hepatology, "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 (PCR) 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 from 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."
The corresponding author for this study is: ML Shiffman,
Virginia Commonwealth Univ, Med Coll Virginia, Hepatol Sect, Box
980711, Richmond, VA 23298 USA. For subscription information for
this journal contact the publisher: W B Saunders Co, Independence
Square West, Curtis Center, Ste 300, Philadelphia, PA 19106-
3399.
AUTHORS: Shiffman, M.L.; Hofmann, C.M.; Luketic, V.A.C.;
Sanyal, A.J.; Contos, M.J.; Mills, A.S.
SOURCE: Hepatology, July 1996;24(1):21-26.
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