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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。慢性丙型肝炎是一种影响肝脏的长期病毒感染，可能会导致永久性肝损伤，偶尔还会导致肝癌。它很少会偶然消失，但在一些患者中，可以通过干扰素治疗，再加上或不加第二种名为利巴韦林的抗病毒药物，将其从血液中清除。最近，聚乙二醇型干扰素和利巴韦林的组合被证明比以前可用的治疗方法更有效地从血液中清除病毒，从而消除感染。丙型肝炎病毒有几种不同的类型，它们被称为基因类型。这项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1、4、5或6的患者的结果将与未接受治疗的相同基因的患者的结果进行比较；如果参与者具有这些基因中的一种，他们有3次机会中的2次接受治疗。所有基因2或3的患者都将接受治疗，因为这些基因的治疗效益更高。聚乙二醇化干扰素α-2b(PEGINTRONTM)是干扰素的一种形式，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，作为液体溶液，用量可变，平均剂量约为2茶匙/剂量(10至15毫升)。在这项研究中接受治疗的受试者将同时接受派罗宁和利巴韦林治疗。注：并不是所有参与这项研究的患者都将接受治疗。2001年，聚乙二醇干扰素α-2b被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一起使用。由于参与者患有晚期肝病，正在等待肝移植，他们可能更难耐受全部剂量的聚乙二醇干扰素和利巴韦林。出于这个原因，这两种药物的起始量将从低开始，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低血细胞计数，特别是低白细胞、低血小板和低血红蛋白(贫血)。如果参与者的血细胞计数过低或在治疗过程中出现，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细胞计数足够高，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.