Intensive Models of HCV Care for Injection Drug Users

注射吸毒者的 HCV 强化护理模式

• 批准号: 8507204
• 负责人: Alain Harris Litwin
• 金额: $ 71.88万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-15 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8507204
• 关键词: Adherence; Adverse effects; Agonist; Antiviral Agents; Caring; Chronic Hepatitis C; Clinic; Clinical Trials; Complex; Computer Simulation; Data; Development; Directly Observed Therapy; Disease; Dose; Drug resistance; Education; Epidemic; Frequencies; Fright; Genotype; Group Therapy; HIV; Health Care Costs; Health Personnel; Healthcare Systems; Hepatitis C; Hepatitis C Prevalence; Hepatitis C Transmission; Hepatitis C virus; Homelessness; Incidence; Infection; Injecting drug user; Injection of therapeutic agent; Intensive Care; Interferons; Intervention; Knowledge; Life; Liver Failure; Liver diseases; Living Costs; Mental disorders; Methadone; Modeling; Motivation; Opiates; Oral; Outcome; Patients; Persons; Pharmaceutical Preparations; Physicians; Play; Poverty; Primary Health Care; Psychiatric therapeutic procedure; Publishing; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Recruitment Activity; Regimen; Resistance; Resistance development; Risk; Role; Site; Social support; Time; Treatment Protocols; Treatment outcome; Trust; United States; Viral; Virus; addiction; arm; base; care delivery; cost; cost effective; cost effectiveness; drug resistant virus; experience; improved; liver transplantation; methadone clinic/center; mortality; multidisciplinary; pill; programs; psychosocial; randomized trial; response; risk perception; skills; standard care; substance abuse treatment; success; treatment site

DESCRIPTION (provided by applicant):Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Up to 90% of HIV-infected IDUs are also infected with HCV. HCV treatment leading to sustained viral response (SVR) is associated with increased survival, but to date IDUs have had poor access to HCV care and their success in HCV treatment has been limited. Although past HCV therapies have been relatively ineffective in genotype-1 infected patients, newer regimens are substantially improved. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients (including HIV/HCV-coinfected patients), compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. Because the life- and costsaving benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients, we are proposing a randomized controlled trial of three models of care. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care (including HIV care), substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections. It is unknown whether either model is better or more cost-effective than standard on-site care. In the proposed study, 150 IDUs (100 HCV-monoinfected and 50 HIV/HCV coinfected) with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; and (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.

描述（由申请人提供）：注射吸毒者（IDU）占美国大约500万人感染了丙型肝炎病毒（HCV）的60％。多达90％的HIV感染IDU也感染了HCV。导致持续病毒反应（SVR）的HCV治疗与生存率增加有关，但迄今为止，IDU的获得HCV护理不良，其在HCV治疗中的成功受到限制。尽管过去的HCV疗法在受到基因型1感染的患者中相对无效，但较新的方案得到了显着改善。使用直接作用抗病毒剂，在大型临床试验中进行的HCV治疗可导致超过70％的基因型1感染患者（包括HIV/HCV可感染的患者）的SVR或治愈，而先前的疗法为45％。但是，在现实世界中，SVR率高达14％。大多数未能达到SVR的患者会产生耐药性，但是最大程度地缩放抗药性的最佳依从水平尚不清楚。如果在当前护理模型中继续进行HCV治疗，那么大多数IDU不仅会失败和发展抗药性，而且可能会将抗性病毒传递给其他人。由于除非我们确定大多数HCV感染的患者的最佳护理模型，否则新的HCV治疗的寿命和成本效益将无法实现，我们提出了三种护理模型的随机对照试验。我们以前已经开发了HCV护理的多学科模型，该模型将现场初级保健（包括艾滋病毒护理），药物滥用治疗，精神科护理和与HCV相关的护理纳入鸦片激动剂治疗诊所。为了最大程度地提高治疗结果，我们试图两种密集型HCV相关护理的模型：直接观察到的治疗（DOT）和并发组治疗（CGT）。在我们的DOT模型中，每周一次给卵毛干扰素进行一次施用，并在美沙酮窗口每天服用一剂口服药物。在我们的CGT模型中，患者在曾经每周治疗组中启动HCV治疗，该治疗组提供了强大的社会支持，以减轻人们对副作用，促进高效教育和每周注射的恐惧。尚不清楚两种模型是比标准现场护理更好还是更具成本效益。在拟议的研究中，将与慢性HCV（基因型1）（基因型1）（基因型1）（基因型1）150个IDU（100 HCV单染色和50 HIV/HCV共感染）从美沙酮诊所招募，并随机分为三种护理模型之一：DOT；并发小组治疗；或标准的现场护理。我们的具体目的是：1）确定两个密集的现场HCV治疗模型（点或并发组治疗）是否比标准现场处理更有效，以提高依从性和SVR，并降低耐药性； （2）确定与IDU中耐药性发展有关的发生率和因素； （3）对每个模型进行成本和成本效益分析； （4）检查HCV感染的IDU中HIV共同感染对依从性和病毒结局的影响。