Lifetime Drinking Patterns & HCV Treatment Outcomes

终生饮酒模式

• 批准号: 7099044
• 负责人: MARCIA RUSSELL
• 金额: $ 51.06万
• 依托单位: PACIFIC INSTITUTE FOR RES AND EVALUATION
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7099044
• 关键词: alcoholic beverage consumption; alcoholism /alcohol abuse; behavioral /social science research tag; clinical research; comorbidity; disease /disorder onset; disease /therapy duration; drug abuse; drug adverse effect; hepatitis C virus; human subject; human therapy evaluation; injection /infusion; interferons; interview; intravenous drug abuse; microorganism disease chemotherapy; patient oriented research; relapse /recurrence; ribavirin; statistics /biometry; substance abuse related behavior; therapy compliance; virus load

DESCRIPTION (provided by applicant): This is a study of lifetime alcohol and drug use among HCV+ patients who have received antiviral therapy. It will provide data needed to inform the development of evidence-based guidelines for treating HCV+ patients with a past or present history of alcohol and/or drug use. Studies of alcohol and drug use in patients with HCV are lacking because recent or current substance abuse is a contraindication for antiviral therapy, and systematic studies have not been conducted in light, moderate drinkers. The clinical and public health importance of establishing effective guidelines for treating HCV in drinkers and drug users is documented by reports that histories of drug use and heavy drinking are prevalent among HCV+ patients, that even moderate drinking may increase the progression of liver disease in HCV patients, that alcohol and drug use may reduce adherence to antiviral treatment regimens, that antiviral treatment may trigger relapses in former drug users, and that drinking impairs responsivity to interferon-based antiviral therapy. Research will be conducted in a sample of 500 HCV+ patients treated with pegylated interferon and ribavirin in the Sacramento Kaiser Permanente Medical Center during or after 2002. Clinical information relevant to patients' HCV treatment will be extracted from Kaiser's computerized databases on laboratory tests, pathology reports, and medical care utilization, and from paper medical reports that document HCV treatment monitoring. Detailed assessments of lifetime substance use will be employed to define drug use and the following alcohol drinking patterns, total consumption, total drinking frequency, intakes per day and per drinking day, and irregular drinking for four critical periods: 1) from the onset of regular drinking to the time patients learned they were HCV+, 2) from the time patients learned they were HCV+ to initiation of HCV treatment, 3) during HCV treatment, and 4) during the six months following completion of HCV treatment. Path analytic techniques will be employed to investigate: 1) direct effects of drinking patterns on sustained viral response (SVR, defined as no HCV RNA in serum six months after treatment ends); 2) indirect effects of drinking patterns on SVR mediated through reduced adherence to antiviral therapy; and 3) relations between drug use and SVR and moderating effects of drug use on the relation between drinking patterns and adherence. Probit and logistic regression analysis will be used to investigate clinically relevant parameters of significant relations between drinking patterns and SVR (e.g., how much do light, moderate, and heavy drinkers need to reduce their alcohol consumption to optimize SVR rates and for how long; do patients with an end-of-treatment viral response fail to obtain an SVR if they start drinking again after HCV treatment ends, and does antiviral treatment precipitate relapses in former substance abusers?).

描述（由申请人提供）：这是一项针对接受抗病毒治疗的 HCV+ 患者终生饮酒和吸毒情况的研究。它将提供所需的数据，为制定治疗有过去或现在饮酒和/或吸毒史的 HCV+ 患者的循证指南提供信息。由于最近或当前的药物滥用是抗病毒治疗的禁忌症，因此缺乏对 HCV 患者饮酒和吸毒的研究，并且尚未对轻度、中度饮酒者进行系统研究。有报道称，HCV+ 患者中普遍存在吸毒和酗酒史，即使适量饮酒也可能会加速 HCV 患者肝病的进展，这证明了建立有效治疗饮酒者和吸毒者 HCV 指南的临床和公共卫生重要性，酒精和药物的使用可能会降低抗病毒治疗方案的依从性，抗病毒治疗可能会引发前吸毒者的复发，并且饮酒会损害对基于干扰素的抗病毒治疗的反应。研究将在 2002 年或之后在萨克拉门托 Kaiser Permanente 医疗中心以 500 名接受聚乙二醇干扰素和利巴韦林治疗的 HCV+ 患者为样本进行。与患者 HCV 治疗相关的临床信息将从 Kaiser 的实验室测试、病理报告计算机化数据库中提取、医疗保健利用，以及记录 HCV 治疗监测的纸质医疗报告。将采用对终生物质使用的详细评估来定义药物使用和以下饮酒模式、总消费量、总饮酒频率、每天和每个饮酒日的摄入量以及四个关键时期的不规则饮酒：1）从定期饮酒开始饮酒至患者得知自己为 HCV+ 时，2) 从患者得知自己为 HCV+ 时至开始 HCV 治疗，3) HCV 治疗期间，以及 4) HCV 治疗完成后六个月内。将采用路径分析技术来研究：1）饮酒模式对持续病毒反应（SVR，定义为治疗结束后六个月血清中没有 HCV RNA）的直接影响； 2) 饮酒模式通过减少抗病毒治疗依从性而对 SVR 产生间接影响； 3) 药物使用与 SVR 之间的关系以及药物使用对饮酒模式与依从性之间关系的调节作用。概率和逻辑回归分析将用于研究饮酒模式与 SVR 之间显着关系的临床相关参数（例如，轻度、中度和重度饮酒者需要减少多少饮酒量以优化 SVR 率以及持续多长时间；具有治疗结束病毒反应的患者如果在 HCV 治疗结束后再次开始饮酒，则无法获得 SVR，抗病毒治疗是否会导致以前的药物滥用者复发？）。