PROSPECTIVE RANDOMIZED CONTROLLED TRIAL TO DETERMINE IF REDUCTION IN

Virginia Commonwealth University, Richmond VA

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Abstract

A trial to determine if a reduction in HCV-RNA titer can identify patients who achieve histologic improvement during treatment with Infergen (concensus interferon) for chronic hepatitis C (HCV). HCV is the most common cause of chronic hepatitis in the United States and other western countries. Approximately four million people in this country are infected with HCV. Nearly 90% of the people are unable to resolve the infection and develop chronic HCV. This progresses to cirrhosis in 33-50% of infected people. The progression takes 15-30 years and can develop into liver cancer. Cirrhosis caused by HCV is responsible for nearly 33% of all people undergoing liver transplantation and for nearly 8,000 deaths annually. It is estimated that deaths due to HCV will triple during the next decade. Concensus interferon is an antiviral medication and is a synthetic alpha-interferon with an amino acid sequence. The ideal goal of interferon treatment is long-term sustained response. Unfortunately, the goal is rarely attained. Approximately 33-50% of people treated with standard doses of various interferons will achieve response. One way to possibly increase this percentage is to increase the dosage. The objectives of this study are a) to determine if a decline in HCV-RNA titer during treatment with interferon can be utilized to identify which patients achieved improvement and, b) to determine if the degree of improvement in patients who have a reduction in HCV-RNA titer is similar to that for patients who achieve viral eradication. The study will enroll at least 300 patients, male and female, having had a liver biopsy in the past six months and have chronic HCV. All patients will begin treatment with concensus interferon three times weekly for three months. If the patient has responded to this dose, she/he will remain on this dose for an additional 15 months. If there is no response, the dose will be increased and will continue for an additional three months. Responses will again be assessed at six months and doses will be adjusted. All patients will be followed in the protocol for 18 months, and will be given an additional liver biopsy after the 18th month to assess response. During participation, patients will undergo routine lab tests to monitor response to the therapy. Alcohol will not be regularly consumed while treatment is ongoing.