MANAGEMENT OF HEPATITIS C IN HIV-INFECTED AND UNINFECTED IDUS

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。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%的注射吸毒者感染了丙型肝炎，丙型肝炎可在20年或更长时间内引起进行性肝纤维化（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，与人类免疫缺陷病毒（HIV）的合并感染存在于30%的HCV感染的注射吸毒者中，并且与HCV相关肝病的更快进展相关。用聚乙二醇干扰素/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，使用或曾经使用过注射毒品的人通常被排除在这些治疗方案之外，患有艾滋病毒感染和精神疾病等其他合并症的人也是如此。这项研究旨在解决这样一个现实，即受HCV感染影响最严重的人是研究最少和治疗最少的人，随着HCV治疗成功率的提高，这种差异变得更加引人注目。然而，由于缺乏关于哪些艾滋病毒感染者和未感染者有资格并需要HCV治疗的数据，HCV治疗的实施受到阻碍。为解决这些问题，我们建议实现以下目标：1）根据绝对和相对标准确定符合PEG/RBV治疗条件的HIV感染者和未感染者的比例; 2）确定符合PEG/RBV治疗条件的HIV感染者和未感染者中HCV治疗的医学必要性（通过肝组织学和非侵入性标志物确定）;和3）评价直接施用与标准护理递送的聚乙二醇化干扰素α加利巴韦林用于治疗HIV感染和未感染的注射吸毒者中的丙型肝炎的安全性、耐受性、功效和成本效益。我们预计提供的数据将对有和没有艾滋病毒合并感染的HCV感染的注射吸毒者的医疗护理以及制定注射吸毒者中丙型肝炎护理的管理和提供政策产生重要影响。

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. 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) To evaluate the safety, tolerability, efficacy and cost-effectiveness of directly-administered versus standard-of-care delivery of pegylated interferon alfa plus ribavirin for the treatment of hepatitis C in HIV-infected and uninfected IDUs. 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.