CLINICAL TRIAL
COMPARATIVE STUDY
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
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Combination treatment of advanced HCV associated liver disease with interferon and G-CSF.

BACKGROUND/AIMS: Interferon (IFN) is the only therapy currently approved for chronic hepatitis C treatment. Unfortunately, not all patients respond to IFN therapy with a disease remission. Some people consider advanced histologic disease to be either a contraindication for treatment or a predictor of a poor response to treatment. To assess the validity of the two preceding widely held views, a total of 30 consecutive patients with advanced histologic disease associated with hepatitis C were studied.

MATERIALS AND METHODS: Patients were treated with 5 million units of IFN administered SQ daily either alone or in combination with G-CSF (300 micrograms SQ on Mondays and Thursdays).

RESULTS: Both groups responded to the IFN therapy with 53 and 60% respectively being HCV-RNA negative after 6 months of therapy and 40 and 53% respectively continuing as HCV-RNA negative after 6 months of follow-up after IFN. The mean white blood cell (WBC) count and peak WBC counts of those receiving G-CSF were greater than those not receiving G-CSF therapy. The nadir values for both groups, however, were similar.

CONCLUSIONS: Based upon this study, utilizing daily high dose IFN (5 MU) therapy, it can be concluded that individuals with advanced histologic disease can be treated successfully with IFN and obtain a prolonged remission. The addition of G-CSF during IFN therapy of patients with histologically advanced disease increases the mean WBC and peak WBC count levels achieved during the course of IFN therapy but without significantly increasing the response rate defined as clearance of HCV-RNA at the end of treatment and follow-up.

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