Patient Oriented Research in Hepatitis C-infected Injection Drug Users

丙型肝炎感染注射吸毒者的以患者为导向的研究

• 批准号: 8640131
• 负责人: Mark Sebastian Sulkowski
• 金额: $ 11.86万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-15 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8640131
• 关键词: AIDS clinical trial group; Acute; Address; Adult; African; Alcohol consumption; Alcoholic Liver Diseases; Alcohols; Antiviral Agents; Antiviral Therapy; Area; Automobile Driving; Award; Behavioral; Bioethics; Biological Markers; Cessation of life; Chronic Hepatitis B; Chronic Hepatitis C; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Combined Modality Therapy; Communicable Diseases; Communities; Conduct Clinical Trials; Data; Development; Disease; Disease Management; Disease Outcome; Doctor of Medicine; Effectiveness; Eligibility Determination; Ensure; Faculty; Fibrosis; Frequencies; Goals; HIV; Heavy Drinking; Hepatitis; Hepatitis B; Hepatitis C; Hepatitis C virus; Histologic; Histology; Immunology; Incentives; Individual; Injecting drug user; Institute of Medicine (U.S.); Intervention; Light; Liver; Liver diseases; Malignant neoplasm of liver; Measures; Medical; Medicine; Mentorship; Metabolic; Methodology; Mid-Career Clinical Scientist Award (K24); Midcareer Investigator Award in Patient-Oriented Research; Outcome; Outcomes Research; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Physician Executives; Pilot Projects; Population; Prevalence; Prevention approach; Prevention strategy; Psychological reinforcement; Public Health; Reporting; Research; Research Personnel; Research Support; Safety; Serum; South Carolina; Specimen; Staging; Targeted Research; Testing; Therapeutic; Time; Training; Training Programs; Translating; Translational Research; Translations; United States National Institutes of Health; Universities; Viral hepatitis; Virus Diseases; Work; antiretroviral therapy; bone; brief alcohol intervention; burden of illness; carbohydrate-deficient transferrin; career; cohort; computerized; drinking; elastography; graduate student; implementation research; improved; innovation; liver biopsy; liver injury; medical schools; mortality; new therapeutic target; novel; patient oriented research; professor; programs; public health relevance; randomized trial; screening, brief intervention, referral, and treatment; standard care; tool; treatment as usual; virology; voucher

DESCRIPTION (provided by applicant): This is a proposal for a K24 Midcareer Investigator Award in Patient-oriented research (POR) for Mark S. Sulkowski, MD of the Johns Hopkins University School of Medicine. Dr. Sulkowski is an Associate Professor of Medicine in the Division of Infectious Diseases (ID) and Medical Director of the ID Viral Hepatitis Center. He leads two complementary POR programs for hepatitis C virus (HCV): HCV/HIV Liver Outcomes Research. The aims of this research are to evaluate long-term outcomes of HCV disease in an NIH-supported longitudinal cohort of adults coinfected with HIV and HCV. Current efforts emphasize the use of tools to determine the impact of antiretroviral therapy and HCV treatment on liver disease including histology and noninvasive transient elastography as well as interventions to improve HCV outcomes such as behavioral reinforcement for HCV treatment. HCV Therapeutics. The aim of this research is to conduct clinical trials of novel direct acting antivirals (DAAs) for the treatment of HCV with the broad goals of validating new therapeutic targets, increasing eradication rates, improving safety and tolerability and translating these findings to the community. The principal aims of this K24 Award proposal are: 1) To create a comprehensive training program that brings together expertise in outcomes research and clinical trials to prepare early clinical investigator for academic careers in POR related to HCV; 2) To dedicate research effort to the advancement of the HCV research agenda in the AIDS Clinical Trials Group (ACTG). This network has led research in HIV/HCV coinfection and has expertise in virology, immunology, pharmacology, metabolic, biostatics, bioethics, and research implementation that are critical to the HCV field; 3) To expand the scope HCV disease management in coinfected adults through the development of a research program focused on harmful alcohol intake which is prevalent in this population, accelerates HCV disease and is a contraindication to HCV treatment. These aims will be addressed in the context of providing mentorship to new and existing junior faculty, infectious diseases fellows and graduate students. The K24 will allow Dr. Sulkowski to more effectively pursue his long-term career goals of improving HCV treatment and translating these treatments to populations of individuals with the highest HCV disease burden. Public Health Relevance: This is a proposal for a Midcareer Investigator Award in Patient-Oriented Research (K24) for Mark S. Sulkowski, M.D. This award will support Dr. Sulkowski's clinical research programs in Hepatitis C; the overarching aim of this research is to improve clinical outcomes in persons with HCV through the conduct clinical trials of novel direct acting antivirals (DAAs) for the treatment of HCV and the translation of improved therapies to populations with the greatest disease burden. These aims are addressed in the context of providing mentorship to new and existing junior faculty, infectious diseases fellows and graduate students.

描述（由申请人提供）：这是为约翰·霍普金斯大学医学院医学博士 Mark S. Sulkowski 申请 K24 职业生涯中期研究员奖 (POR) 的以患者为导向的研究 (POR) 的提案。 Sulkowski 博士是传染病科 (ID) 医学副教授兼 ID 病毒性肝炎中心医疗主任。他领导了两个针对丙型肝炎病毒 (HCV) 的补充 POR 项目：HCV/HIV 肝脏结果研究。本研究的目的是评估 NIH 支持的同时感染 HIV 和 HCV 的成人纵向队列中 HCV 疾病的长期结果。目前的工作强调使用工具来确定抗逆转录病毒治疗和丙型肝炎治疗对肝病的影响，包括组织学和无创瞬时弹性成像以及改善丙型肝炎结果的干预措施，例如丙型肝炎治疗的行为强化。丙肝病毒治疗。本研究的目的是开展用于治疗 HCV 的新型直接作用抗病毒药物 (DAA) 的临床试验，其广泛目标是验证新的治疗靶点、提高根除率、提高安全性和耐受性，并将这些发现转化为社区。该 K24 奖项提案的主要目标是： 1) 创建一个综合培训计划，汇集结果研究和临床试验方面的专业知识，为 HCV 相关 POR 学术生涯的早期临床研究者做好准备； 2) 致力于推进艾滋病临床试验组 (ACTG) 的丙型肝炎研究议程。该网络主导了 HIV/HCV 合并感染的研究，并拥有对 HCV 领域至关重要的病毒学、免疫学、药理学、代谢、生物统计学、生物伦理学和研究实施方面的专业知识； 3) 通过制定一项以有害酒精摄入为重点的研究计划，扩大合并感染成人的丙肝病毒疾病管理范围，有害酒精摄入在该人群中普遍存在，会加速丙肝病毒疾病，并且是丙肝病毒治疗的禁忌症。这些目标将在为新任和现有初级教师、传染病研究员和研究生提供指导的背景下得到实现。 K24 将使 Sulkowski 博士能够更有效地追求其长期职业目标，即改善 HCV 治疗并将这些治疗方法应用于 HCV 疾病负担最高的人群。 公共卫生相关性：这是一项为医学博士 Mark S. Sulkowski 颁发的以患者为导向的研究 (K24) 中职业生涯调查员奖的提案。该奖项将支持 Sulkowski 博士在丙型肝炎方面的临床研究项目；这项研究的总体目标是通过开展用于治疗 HCV 的新型直接作用抗病毒药物 (DAA) 的临床试验以及向疾病负担最严重的人群推广改进的疗法，改善 HCV 患者的临床结果。这些目标是在为新的和现有的初级教师、传染病研究员和研究生提供指导的背景下实现的。