HIV-Infected Patients' Experiences with HCV Treatment

描述（由申请人提供）：在美国，慢性丙型肝炎病毒（HCV）感染影响了40,000名HIV阳性患者。丙型肝炎病毒治疗与危及生命的副作用和抗逆转录病毒药物相互作用有关。如果不进行治疗，越来越多的艾滋病毒阳性患者要么死于终末期肝病，要么死于艾滋病毒相关并发症，原因是由于抗逆转录病毒药物的肝毒性而无法使用。数据有限，但临床印象是这一人群很少接受或完成HCV治疗。需要更多关于艾滋病毒感染患者在管理HCV治疗过程中的经验的信息。这项定性、纵向研究的目的是对hiv感染患者接受HCV治疗的经历有一个清晰的认识。这一认识将提高我们设计临床干预措施的能力，支持对合并感染患者的HCV治疗。本研究的具体目的是：(1)描述艾滋病毒感染患者在处理HCV治疗过程中的主观体验，(2)检查与健康相关的生活质量、症状体验、精神疾病、药物滥用以及卫生保健提供者对合并感染患者HCV治疗体验的影响，以及(3)探索人口统计学、临床辅助因素与HCV治疗体验之间的关联。将在三个时间点（治疗前、治疗后8-12周和治疗结束时）对40名HCV/HIV合并感染患者进行深入的定性访谈。选择不接受治疗的受试者也将接受采访。将采用内容分析的恒常比较法对HCV治疗经验的访谈数据进行抽象。meta矩阵将用于整合定性、人口统计学和临床辅助因素数据（HCV治疗依从性、HIV RNA、HCV RNA、HCV基因型、肝脏病理、全血细胞计数、肝功能检查、HIV疾病阶段和与抗逆转录病毒药物的联合治疗）。这项拟议的研究是为在hiv感染患者中测试HCV治疗干预措施的临床试验奠定基础的重要一步。这项研究的结果对临床医生、教育工作者、研究人员和那些为丙型肝炎病毒/艾滋病毒合并感染患者制定治疗指南的人也很有价值。

DESCRIPTION (provided by applicant): Chronic hepatitis C virus (HCV) infection affects 40,000 HIV positive patients in the United States. HCV treatment is associated with life-threatening side effects and antiretroviral drug interactions. Without treatment, increasing numbers of HIV positive patients will either die from end stage liver disease or from HIV-related complications because of the inability to use antiretroviral agents due to their hepatotoxicity. Data are limited, but the clinical impression is that this population less often accepts or completes HCV treatment. More information is needed about the experience of HIV-infected patients as they manage the process of HCV treatment. The purpose of this qualitative, longitudinal study is to develop a clear understanding of HIV-infected patients' experiences with HCV treatment. This understanding will improve our ability to design clinical interventions that support HCV treatment efforts in co-infected patients. The specific aims of this study are to (1) describe the subjective experiences of HIV-infected patients as they manage the process of HCV treatment, (2) examine the influence of health related quality of life, symptom experience, mental illness, substance abuse and the role of health care providers on the experience of HCV treatment in co-infected patients, and (3) explore the association between demographic, clinical cofactors and the HCV treatment experience. In-depth qualitative interviews will be conducted with 40 HCV/HIV co-infected patients at three time points (before treatment, 8-12 weeks into treatment and at treatment completion). Subjects who choose not to be treated will be interviewed also. The constant comparative method of content analysis will be used to abstract interview data on the HCV treatment experience. A meta-matrix will be used to integrate the qualitative, demographic and clinical cofactor data (HCV treatment adherence, HIV RNA, HCV RNA, HCV genotype, liver pathology, complete blood counts, liver function tests, HIV illness stage and co-treatment with antiretroviral agents). The proposed study is an essential step towards developing the foundation for clinical trials that test HCV treatment interventions among HIV-infected patients. Results of this study will also be valuable to clinicians, educators, researchers and those who develop treatment guidelines for HCV/HIV co-infected patients.