Does dose escalation of interferon result in a greater
improvement in patients with chronic hepatitis?
D. Nunes; Boston City Hospital and West Roxbury VA Medical
Center Boston, MA
Presented May 19, 1996
Because less than 25% of patients with chronic hepatitis C
treated with currently employed levels of alpha-interferon
experience a sustained response to treatment, Dr Nunes and
colleagues conducted a randomized study to evaluate the effect of
escalating doses of interferon on HCV-RNA status.
A total of 61 patients were randomized (at a 1:2 ratio) to
receive either a standard dose of interferon (3 million units three
times a week) or to an escalating dose arm to receive 3 million
units three times a week increased to 5 million units three time a
week after two months and then 10 million units three time a week
after 4 months if they remained HCV-RNA- positive at each of the
two time intervals. Total treatment for all patients (21
non-escalating and 40 dose-escalating) was 6 months.
After 6 months of therapy and at 10 months follow-up, there was
no significant difference between the two treatment groups in terms
of the percentage of patients converted to HCV-RNA- negative
Patients with phenotype 1 had the poorest response, with
approximately 40% remaining HCV-RNA-positive, whereas, no patients
with phenotypes 2 or 3 failed to convert to HCV-RNA- negative
status. The differences between patients with phenotype 1 and
phenotypes 2 and 3 were highly significantly different.
One patient in the non-escalating arm died of hepatic failure
and one was withdrawn because of side effects. In the escalating
arm, one patient was withdrawn due to side effects. Dr. Nunes
concluded his presentation by stating that in general, dose
escalation was not associated with a higher rate of either
transient or sustained loss of HCV viremia. However, he did
acknowledge that an increase in dose to 5 million units three times
a week may benefit a subset of patients not responding to 3 million
units. Increasing the dose further to 10 million units three times
a week did not confer any additional benefits.
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