Management/Hepatitis C/HIV-infected and Uninfected IDU's

描述（由申请人提供）：在美国，注射吸毒是HCV传播的主要方式，大多数注射吸毒者都有HCV感染。在东巴尔的摩，80-90%的注射吸毒者感染丙型肝炎，可导致20年或更长时间的进行性肝纤维化（肝硬化），在一些患者中导致终末期肝病、肝细胞癌和死亡。此外，30%的丙型肝炎病毒感染注射吸毒者中存在人类免疫缺陷病毒（HIV）合并感染，并与丙型肝炎相关肝病的更快进展有关。用聚乙二醇化干扰素/利巴韦林（PEG/RBV）治疗丙型肝炎可根除约一半患者的HCV感染。然而，使用或曾经使用注射药物的人，以及患有艾滋病毒感染和精神疾病等其他合并症的人，通常被排除在这些治疗方案之外。这项研究旨在解决这样一个现实，即受丙型肝炎病毒感染影响最大的人是被研究最少、治疗最少的人，随着丙型肝炎病毒治疗成功率的提高，这一差距变得更加引人注目。然而，由于缺乏关于艾滋病毒感染和未感染的注射吸毒者有资格并需要丙型肝炎病毒治疗的数据，丙型肝炎病毒护理的实施受到阻碍。为了解决这些问题，我们建议实现以下目标：1)根据绝对和相对标准确定hiv感染和未感染的注射吸毒者中有资格接受PEG/RBV治疗的比例；2)确定符合PEG/RBV条件的hiv感染者和未感染者治疗HCV的医学必要性（通过肝脏组织学和非侵入性标志物确定）；3)鉴于调查小组的经验和广泛的初步研究，我们期望提供的数据将对合并和未合并艾滋病毒感染的丙型肝炎注射吸毒者的医疗护理以及在注射吸毒者中管理和提供丙型肝炎护理的政策的制定产生重要影响。

DESCRIPTION (provided by applicant): Injection drug use is the predominant mode of HCV transmission in the United States and most injection drug users have HCV infection. In East Baltimore, 80-90% of IDUs are infected with hepatitis C, which can cause progressive hepatic fibrosis (cirrhosis) over 20 or more years, leading, in some patients, to end-stage liver disease, hepatocellular carcinoma and death. Furthermore, coinfection with human immunodeficiency virus (HIV) is present in 30% of HCV-infected IDUs, and is associated with the more rapid progression of HCV-related liver disease. Treatment of hepatitis C with pegylated interferon/ribavirin (PEG/RBV) eradicates HCV infection in approximately one-half of patients. However, persons who use or have used injection drugs are typically excluded from these treatment protocols, as are persons with other comorbidities such as HIV infection and psychiatric disease. This research aims to address the reality that the persons most affected by HCV infection are the least studied and the least treated, a disparity that becomes even more compelling as the success of HCV therapy increases. However, the implementation of HCV care is hindered by the paucity of data regarding which HIV-infected and uninfected IDUs are eligible and need HCV treatment. To address these issue we propose to accomplish the following aims: 1) to determine proportion of HIV-infected and uninfected IDUs who are eligible for HCV therapy with PEG/RBV according to absolute and relative criteria; 2) To determine the medical necessity of HCV treatment among HIV-infected and uninfected persons who are eligible for the PEG/RBV (determined by liver histology and non-invasive markers); and 3) Given the experience of the investigative team and the extensive preliminary research, we anticipate providing data that will have important impact on the medical care HCV-infected IDUs with and without HIV coinfection as well as the development of policies for the management and delivery of hepatitis C care among IDUs.