A2ALL LADR PROTOCOL:PRE-TRNSPLNT TRTMNT TO PRVNT RCURRNCE OF HEPC AFT LVR TRNSPL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic hepatitis C is a long-lasting viral infection affecting the liver that may lead to permanent liver damage and, occasionally, to liver cancer. It rarely disappears by chance, but may be cleared from the bloodstream in some patients by interferon therapy, with or without a second anti-viral agent called ribavirin. The combination of peginterferon alpha and ribavirin has recently been shown to be more effective than prior available treatments in clearing the virus from the blood, and therefore getting rid of the infection. There are several different types of Hepatitis C virus and they are called genotypes. The purpose of this study is to determine how safe and how effective treatment with combination peginterferon alfa-2b plus ribavirin is in preventing the return of hepatitis C after transplant. The results from patients in genotype 1, 4, 5, or 6 who receive treatment will be compared to the results of patients in the same genotypes who do not receive treatment; if the participant has one of these genotypes they have 2 chances out of 3 to receive the treatment. All patients with genotypes 2 or 3 will receive treatment as the treatment benefit is higher with these genotypes. Peginterferon alfa-2b (PEGINTRONTM) is a form of interferon that lasts a long time in the blood stream and is given once a week. Ribavirin is taken orally (by mouth) twice a day, as a liquid solution in variable amounts with an average dose of approximately 2 teaspoons/dose (10 to 15 ml). Subjects who are treated in this study will receive both PEGINTRONTM + ribavirin. NOTE: not all patients who join this study will receive treatment. Peginterferon alfa-2b was approved by the Food and Drug Administration for treatment of hepatitis C in 2001, and Ribavirin was approved for use with Peginterferon alfa-2b in August, 2001. Because the participants have advanced liver disease and are awaiting liver transplantation, they may be less able to tolerate full doses of both peginterferon and ribavirin. For this reason the starting doses of both drugs will begin low and then doses will be increased based on their tolerance to the treatment. One of the clinical problems encountered in patients with advanced liver disease are low blood cell counts, specifically low white cells, low platelets, and low hemoglobin (anemia). If a participant has excessively low blood counts or develops them on treatment they may receive additional treatment, called growth factors (erythropoietin analogue (EPO) or granulocyte-colony stimulating factor (G-CSF)). The goal of using growth factors is to keep their blood counts high enough so that they can be treated with adequate doses of peginterferon and ribavirin.