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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。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，偶尔也会导致肝癌。它很少会偶然消失，但在某些患者中，可以通过干扰素治疗从血液中清除，使用或不使用第二种抗病毒药物利巴韦林。聚乙二醇干扰素α和利巴韦林的组合最近已被证明比先前可用的治疗更有效地清除血液中的病毒，从而摆脱感染。 丙型肝炎病毒有几种不同的类型，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。将基因型1、4、5或6接受治疗的患者的结果与相同基因型但未接受治疗的患者的结果进行比较;如果受试者具有这些基因型之一，则他们有3次机会中的2次接受治疗。所有基因型为2或3的患者都将接受治疗，因为这些基因型的治疗获益更高。 聚乙二醇干扰素α-2b（PEGINTRONTM）是一种干扰素，在血流中持续很长时间，每周给药一次。利巴韦林是口服（口服），每天两次，作为液体溶液，在变量与平均剂量约2茶匙/剂量（10至15毫升）。在本研究中接受治疗的受试者将接受PEGINTRON TM+利巴韦林。注：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并正在等待肝移植，他们可能不太能够耐受全剂量的聚乙二醇干扰素和利巴韦林。因此，两种药物的起始剂量开始较低，然后根据其对治疗的耐受性增加剂量。晚期肝病患者遇到的临床问题之一是低血细胞计数，特别是低白色细胞、低血小板和低血红蛋白（贫血）。如果受试者的血细胞计数过低或在治疗中出现，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））。使用生长因子的目标是保持他们的血细胞计数足够高，以便可以用足够剂量的聚乙二醇干扰素和病毒唑进行治疗。

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.