Lifetime Drinking Patterns & HCV Treatment Outcomes

描述(申请人提供)：这是一项关于接受抗病毒治疗的丙型肝炎病毒阳性患者的终生酒精和药物使用情况的研究。它将提供必要的数据，为制定治疗过去或现在有酒精和/或药物使用史的丙型肝炎病毒阳性患者的循证指南提供信息。由于最近或目前的药物滥用是抗病毒治疗的禁忌症，而且还没有对轻度、中度饮酒者进行系统研究，因此缺乏关于丙型肝炎患者酒精和药物使用的研究。为饮酒者和吸毒者制定有效的治疗丙型肝炎病毒指南的临床和公共卫生重要性在以下报告中得到了证明：丙型肝炎病毒阳性患者中普遍有药物使用和大量饮酒的病史，即使是适度饮酒也可能增加丙型肝炎患者的肝病进展，酒精和药物使用可能会降低抗病毒治疗方案的依从性，抗病毒治疗可能会导致前吸毒者复发，饮酒会损害基于干扰素的抗病毒治疗的反应性。2002年或以后，萨克拉门托凯撒永久医疗中心将对500名接受聚乙二醇化干扰素和利巴韦林治疗的丙型肝炎病毒阳性患者进行研究。与患者丙型肝炎治疗相关的临床信息将从Kaiser的实验室测试、病理报告和医疗保健利用的计算机化数据库中提取，并从记录丙型肝炎病毒治疗监测的纸质医疗报告中提取。对终生药物使用的详细评估将被用来确定药物使用和以下饮酒模式、总消耗量、总饮酒频率、每天和每天的饮酒量以及四个关键时期的不规律饮酒：1)从开始正常饮酒到患者得知自己是丙型肝炎病毒阳性，2)从患者得知自己是丙型肝炎病毒阳性到开始丙型肝炎病毒治疗，3)在丙型肝炎病毒治疗期间，以及4)在丙型肝炎病毒治疗完成后的6个月期间。通径分析技术将被用来调查：1)饮酒模式对持续病毒应答(SVR，定义为治疗结束后6个月血清中没有丙型肝炎病毒RNA)的直接影响；2)饮酒模式对SVR的间接影响，通过减少对抗病毒治疗的依从性；以及3)药物使用与SVR的关系以及药物使用的调节作用对饮酒模式与依从性之间的关系。将使用概率和Logistic回归分析来调查饮酒模式与SVR之间显著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酒精摄入量以优化SVR率以及持续多长时间；治疗结束后病毒应答的患者如果在丙型肝炎治疗结束后再次开始饮酒是否无法获得SVR，以及抗病毒治疗是否会导致既往药物滥用者的复发？)。

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?).