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）：这是对接受抗病毒疗法的HCV+患者中终身酒精和药物使用的研究。它将提供所需的数据，以告知制定基于证据的指南，以治疗使用过过去或现在的酒精和/或吸毒史的HCV+患者。缺乏对HCV患者的酒精和药物使用的研究，因为最近或当前的药物滥用是抗病毒疗法的禁忌症，并且尚未在光线，中度饮酒者中进行系统研究。 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基于干扰素的抗病毒疗法。研究将在2002年或之后的萨克拉曼多·凯撒（Sacramento Kaiser Permanente）医疗中心的500例HCV+患者样本中进行。与患者的HCV治疗相关的临床信息将从Kaiser的计算机数据库中提取与患者的HCV治疗相关的临床信息。详细评估终身用品的详细评估将用于定义吸毒和以下饮酒方式，总消费，总饮酒频率，每天的摄入量，每天的摄入量和每天的饮酒日以及四个关键时期的不规则饮酒：1）从常规饮酒开始到患者到六个月以后，患者在治疗HCV+ hcv+ hcv the HCV之后，在HCV+ hcv hcv hcv the HCV之后，在HCV中进行了3个月， HCV处理。路径分析技术将用于研究：1）饮酒模式对持续病毒反应的直接影响（SVR，在治疗结束后六个月定义为血清中无HCV RNA）； 2）通过降低抗病毒疗法的依从性，饮酒模式对SVR的间接影响； 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调查饮酒方式与SVR之间显着关系的临床相关参数（例如，光，中度和重型饮酒者需要减少多少光，中度和重型饮酒者需要减少其饮酒量，以优化SVR率，以优化SVR的速率，并以较长的速度；如果在HCV后再进行饮酒后，则需要进行急诊室的降临，并且在HCV后无法进行治疗，并且在HCV后又无法进行治疗。施虐者？）。