Treatment Disparities/Outcomes of HCV-HIV Co-Infection

描述(由申请人提供)： 全球约有400万美国人和1.7亿人感染了丙型肝炎病毒。每年有8,000-10,000名美国人死于丙型肝炎。丙型肝炎病毒引起的终末期肝病是美国肝移植的主要原因之一。丙型肝炎病毒和人类免疫缺陷病毒(HIV)的混合感染很常见，在美国，超过三分之一的HIV感染患者是同时感染丙型肝炎病毒的。尽管感染率和死亡率很高，但很少有丙型肝炎患者和更少的丙型肝炎病毒与艾滋病毒混合感染的患者接受丙型肝炎病毒的治疗。此外，丙型肝炎病毒与艾滋病病毒混合感染患者接受丙型肝炎病毒治疗后的长期结果尚不清楚。这项申请的目的是研究HIV合并感染患者和非HIV合并感染患者的丙型肝炎病毒治疗模式，以及治疗后的临床结果，并为申请人在丙型肝炎病毒-艾滋病毒联合感染领域的独立研究生涯做好准备。具体的研究目的是确定：i)丙型肝炎病毒-艾滋病毒混合感染患者接受丙型肝炎病毒治疗的可能性是否低于单独感染丙型肝炎病毒的患者，以及这种差异是否可以由艾滋病毒合并感染本身、年龄、种族、性别、精神病史以及药物和酒精使用来解释；ii)接受丙型肝炎病毒治疗的丙型肝炎病毒感染患者是否比单独接受丙型肝炎病毒感染的患者完成疗程的可能性更低，并了解与未能完成治疗相关的因素；以及iii)完成治疗的患者是否通过存活、急诊科就诊、肝病相关住院和肝细胞癌发病率。研究人群将是1999至2002年间进入国家退伍军人管理局数据库的所有感染丙型肝炎病毒的退伍军人。1999-2001年间，退伍军人管理局医疗系统新诊断为丙型肝炎抗体阳性的患者总数为109,700人。将研究人口和社会变量、丙型肝炎病毒治疗的处方和完成情况、包括存活率在内的临床结果、与肝病相关的住院治疗、对与肝病相关的疾病的紧急护理的利用情况以及肝细胞癌的发展。这些信息将从使用ICD 9代码的国家退伍军人管理局行政数据库和药房福利管理数据库中检索。为了达到本申请的教育目标，申请者将报名参加匹兹堡大学临床研究培训计划，完成临床有效性和结果研究理学硕士学位的课程工作，并积极参与医学院的继续教育活动。申请者的长期目标是对丙型肝炎病毒的治疗模式和结果产生临床相关的影响，特别是在丙型肝炎病毒和艾滋病毒合并感染的患者中。

DESCRIPTION (provided by applicant): About 4 million Americans, and 170 million persons worldwide are infected with the Hepatitis C virus (HCV). Each year, 8,000-10,000 Americans die of HCV. End stage liver disease due to HCV is one of the leading cause for liver transplantation in the United States. Co-infection with HCV and human immunodeficiency virus (HIV) is common with over one-third of the HIV infected patients in the US being co-infected with HCV. Despite high prevalence and mortality, very few patients with HCV and even fewer with HCV-HIV co-infection receive treatment for HCV. Additionally, the long term outcomes after HCV treatment in HCV-HIV co-infected patients are unknown. The goal of this application is to study the treatment patterns of HCV in patients with and without HIV co-infection, and the clinical outcomes after treatment and to prepare the applicant for an independent research career in the field of HCV-HIV co-infection. The specific research aims are to determine i) whether HCV-HIV co-infected patients are less likely to receive treatment for HCV than those infected with HCV alone, and whether this disparity could be explained by HIV co-infection itself, age, race, gender, history of psychiatric illness, and drug and alcohol use ii) whether HCV-HIV infected patients who do receive treatment for HCV are less likely to complete the course of treatment when compared with HCV alone infected patients, and to understand the factors associated with failure to complete treatment, and iii) whether patients who complete the treatment have improved outcomes as measured by survival, emergency department visits, liver disease related hospitalization and incidence of hepatocellular carcinoma. The study population will be all HCV infected Veterans who have been entered in the national VA administrative database between 1999 and 2002. The total number of patients newly diagnosed to be HCV antibody positive in the VA Healthcare System during 1999-2001 was 109,700. Demographic and social variables, prescription and completion of HCV treatment, clinical outcomes including survival, liver disease related hospitalizations, utilization of emergency care for liver disease related conditions and development of hepatocellular carcinoma will be studied. This information will be retrieved from the national VA administrative database using ICD 9 codes, and from the Pharmacy Benefits Management database. To attain the educational goals of this application, the applicant will enroll in University of Pittsburgh Clinical Research Training Program, to complete course work for a Masters of Science degree in Clinical Effectiveness and Outcomes Research, and participate actively in the School of Medicine's continuing educational activities. The long term objective of the applicant is to make a clinically relevant impact on the HCV treatment patterns and outcomes, especially in the HCV-HIV co-infected patients.