Patient Oriented Research in Hepatitis C-infected Injection Drug Users

描述（由申请人提供）：这是一份为约翰霍普金斯大学医学院的Mark S. Sulkowski博士申请K24患者导向研究（POR）中期研究者奖的提案。Sulkowski博士是传染病部（ID）的医学副教授和ID病毒性肝炎中心的医学主任。他领导了两个互补的丙型肝炎病毒（HCV）扶贫项目：HCV/HIV肝脏预后研究。本研究的目的是评估美国国立卫生研究院支持的成人HIV和HCV合并感染的HCV疾病的长期结局。目前的努力强调使用工具来确定抗逆转录病毒治疗和HCV治疗对肝脏疾病的影响，包括组织学和无创瞬时弹性成像，以及改善HCV结局的干预措施，如HCV治疗的行为强化。丙肝病毒疗法。本研究的目的是开展治疗HCV的新型直接作用抗病毒药物（DAAs）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。K24奖提案的主要目的是：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，为与HCV相关的POR学术生涯的早期临床研究者做好准备；2)致力于艾滋病临床试验组（ACTG） HCV研究议程的推进。该网络领导了艾滋病毒/丙型肝炎病毒合并感染的研究，并拥有对丙型肝炎病毒领域至关重要的病毒学、免疫学、药理学、代谢、生物静力学、生物伦理学和研究实施方面的专业知识；3)通过开展一项研究计划，扩大合并感染成人的HCV疾病管理范围，该研究计划侧重于有害酒精摄入，这在该人群中普遍存在，加速了HCV疾病的发展，是HCV治疗的禁忌症。这些目标将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得到解决。K24将使Sulkowski博士能够更有效地追求他的长期职业目标，即改善HCV治疗并将这些治疗方法转化为HCV疾病负担最高的人群。

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.