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Study shows positive findings in treating patients with advanced hepatitis C
Date:4/24/2008

tients. Those who do not respond and have cirrhosis are at far greater risk for developing liver cancer or liver failure, so the development of treatment strategies for these nonresponders is a priority.

Conducted at approximately 40 sites in the United States, the COPILOT study compared weight-based low-dose peginterferon alfa-2b (subcutaneous injection of 0.5 mcg/kg/wk, one-third the dose used in standard HCV combination therapy) versus colchicine (0.6 mg orally, twice daily), an anti-inflammatory and antifibrotic medication, in 555 chronic hepatitis C patients with advanced liver fibrosis who previously failed interferon-based therapies. Patient baseline characteristics were well balanced between the two study arms. Over the four years of the randomized study, investigators monitored the patients to determine how many reached a primary endpoint, defined as death, liver transplant, hepatocellular carcinoma (liver cancer), variceal bleeding, or liver failure (increase in Child-Pugh-Turcotte [CPT] by 2 points with ascites, jaundice or encephalopathy). They analyzed their findings for all 555 patients, who received at least one dose of their assigned drug, in two ways: based on all events that occurred during the entire four years of the study, regardless of whether a patient was still taking their assigned drug or not (the intent-to-treat or ITT analysis), and based on only the events that occurred while patients were taking their assigned drug (the on drug analysis).

The investigators found a primary endpoint was reached by 17.8% (51/286) of patients in the peginterferon alfa-2b group versus 20.4% (55/269) in the colchicine group in the ITT analysis, and by 12.2% (35/286) and 16.0% (43/269) patients, respectively, in the on-drug analysis (treatment differences were not statistically significant). Among patients who had portal hypertension (42.3% and 48.0% of patients in the peginterferon alfa-2b and colchicine groups, respectively), peginterfero
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Contact: Bonnie Prescott
bprescot@bidmc.harvard.edu
617-667-7306
Beth Israel Deaconess Medical Center
Source:Eurekalert

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