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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 status.

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One patient in the non-escalating arm died of hepatic failure and one was withdrawn because of side effects. In the escalating arm, one patient was withdrawn due to side effects.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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