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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。慢性丙型肝炎是一种影响肝脏的长期病毒感染，可能导致永久性肝损伤，偶尔还会导致肝癌。它很少偶然消失，但在一些患者中，通过干扰素治疗，或者不使用第二种抗病毒药物利巴韦林，它可能会从血液中清除。聚乙二醇干扰素α和利巴韦林的组合最近被证明比以前可用的治疗方法更有效地清除血液中的病毒，从而消除感染。有几种不同类型的丙型肝炎病毒，它们被称为基因型。本研究的目的是确定聚乙二醇干扰素α -2b联合利巴韦林在预防移植后丙型肝炎复发方面的安全性和有效性。接受治疗的基因型1、4、5或6患者的结果将与未接受治疗的相同基因型患者的结果进行比较；如果参与者有这些基因型中的一种，他们有三分之二的机会接受治疗。所有基因型2或3的患者都将接受治疗，因为这些基因型的治疗效果更高。聚乙二醇干扰素α -2b （PEGINTRONTM）是一种干扰素，在血液中持续很长时间，每周给药一次。利巴韦林每天口服（口服）两次，作为可变量的液体溶液，平均剂量约为2茶匙/剂（10至15毫升）。在本研究中接受治疗的受试者将同时接受PEGINTRONTM +利巴韦林。注意：并非所有参加本研究的患者都将接受治疗。聚乙二醇干扰素- α -2b于2001年被美国食品和药物管理局批准用于治疗丙型肝炎，利巴韦林于2001年8月被批准与聚乙二醇干扰素- α -2b联合使用。由于参与者患有晚期肝病，正在等待肝移植，他们可能无法耐受全剂量的聚乙二醇干扰素和利巴韦林。由于这个原因，两种药物的开始剂量都很低，然后根据它们对治疗的耐受性增加剂量。晚期肝病患者的临床问题之一是血细胞计数低，特别是白细胞、血小板和血红蛋白低（贫血）。如果参与者有过低的血液计数或发展他们的治疗，他们可能会接受额外的治疗，称为生长因子（促红细胞生成素类似物（EPO）或粒细胞集落刺激因子（G-CSF））。使用生长因子的目的是保持他们的血液计数足够高，这样他们就可以用足够剂量的聚乙二醇干扰素和利巴韦林进行治疗。

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.