MANAGEMENT OF HEPATITIS C IN HIV-INFECTED & UNINFECTED IDUS

HIV 感染者丙型肝炎的治疗

• 批准号: 7604582
• 负责人: Mark Sebastian Sulkowski
• 金额: $ 15.29万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604582
• 关键词: Address; Affect; Baltimore; Caring; Cessation of life; Cirrhosis; Comorbidity; Computer Retrieval of Information on Scientific Projects Database; Data; Drug usage; Funding; Grant; HIV; Hepatitis C; Hepatitis C Transmission; Hepatitis C virus; Histology; Injecting drug user; Injection of therapeutic agent; Institution; Interferons; Invasive; Liver; Liver Fibrosis; Liver diseases; Medical; Mental disorders; Patients; Pegylated Interferon Alfa; Persons; Pharmaceutical Preparations; Policy Developments; Primary carcinoma of the liver cells; Relative (related person); Research; Research Personnel; Resources; Ribavirin; Safety; Source; Staging; Standards of Weights and Measures; Treatment Protocols; United States; United States National Institutes of Health; Virus Diseases; care delivery; cost effectiveness; development policy; success

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 注射吸毒是美国HCV传播的主要方式，大多数注射吸毒者都感染了HCV。在东巴尔的摩，80-90% 的注射吸毒者感染丙型肝炎，这种病毒可在 20 年或更长时间内导致进行性肝纤维化（肝硬化），在某些患者中导致终末期肝病、肝细胞癌和死亡。 此外，30% 的 HCV 感染注射吸毒者中存在人类免疫缺陷病毒 (HIV) 的合并感染，并且与 HCV 相关肝病的更快进展有关。 使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，即受丙型肝炎病毒感染影响最严重的人研究和治疗最少，随着丙型肝炎病毒治疗成功率的提高，这种差距变得更加引人注目。 然而，由于缺乏关于哪些艾滋病毒感染者和未感染的注射吸毒者符合资格并需要丙肝治疗的数据，丙肝治疗的实施受到阻碍。 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有资格接受 PEG/RBV HCV 治疗的 HIV 感染者和未感染者的比例； 2) 确定符合 PEG/RBV 资格的 HIV 感染者和未感染者中 HCV 治疗的医疗必要性（通过肝脏组织学和非侵入性标志物确定）； 3) 评估直接给药与标准护理相比聚乙二醇化干扰素α加利巴韦林治疗 HIV 感染和未感染的注射吸毒者丙型肝炎的安全性、耐受性、有效性和成本效益。 我们预计提供的数据将对感染 HCV 的注射吸毒者（无论是否合并感染 HIV）的医疗保健以及制定管理和提供注射吸毒者丙型肝炎护理的政策产生重要影响。