Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia.
Atlanta Veterans Affairs Medical Center, Decatur, Georgia.
JAMA Netw Open. 2023 Sep 5;6(9):e2335715. doi: 10.1001/jamanetworkopen.2023.35715.
Some payers and clinicians require alcohol abstinence to receive direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection.
To evaluate whether alcohol use at DAA treatment initiation is associated with decreased likelihood of sustained virologic response (SVR).
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used electronic health records from the US Department of Veterans Affairs (VA), the largest integrated national health care system that provides unrestricted access to HCV treatment. Participants included all patients born between 1945 and 1965 who were dispensed DAA therapy between January 1, 2014, and June 30, 2018. Data analysis was completed in November 2020 with updated sensitivity analyses performed in 2023.
Alcohol use categories were generated using responses to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire and International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses for alcohol use disorder (AUD): abstinent without history of AUD, abstinent with history of AUD, lower-risk consumption, moderate-risk consumption, and high-risk consumption or AUD.
The primary outcome was SVR, which was defined as undetectable HCV RNA for 12 weeks or longer after completion of DAA therapy. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% CIs of SVR associated with alcohol category.
Among 69 229 patients who initiated DAA therapy (mean [SD] age, 62.6 [4.5] years; 67 150 men [97.0%]; 34 655 non-Hispanic White individuals [50.1%]; 28 094 non-Hispanic Black individuals [40.6%]; 58 477 individuals [84.5%] with HCV genotype 1), 65 355 (94.4%) achieved SVR. A total of 32 290 individuals (46.6%) were abstinent without AUD, 9192 (13.3%) were abstinent with AUD, 13 415 (19.4%) had lower-risk consumption, 3117 (4.5%) had moderate-risk consumption, and 11 215 (16.2%) had high-risk consumption or AUD. After adjustment for potential confounding variables, there was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or AUD (OR, 0.95; 95% CI, 0.85-1.07). There was no evidence of interaction by stage of hepatic fibrosis measured by fibrosis-4 score (P for interaction = .30).
In this cohort study, alcohol use and AUD were not associated with lower odds of SVR. Restricting access to DAA therapy according to alcohol use creates an unnecessary barrier to patients and challenges HCV elimination goals.
一些支付方和临床医生要求在接受慢性丙型肝炎病毒（HCV）感染的直接作用抗病毒（DAA）治疗之前戒酒。
评估 DAA 治疗开始时的饮酒情况是否与持续病毒学应答（SVR）的可能性降低有关。
设计、地点和参与者：这是一项回顾性队列研究，使用了来自美国退伍军人事务部（VA）的电子健康记录，VA 是提供 HCV 治疗无限制通道的最大综合性国家医疗保健系统。参与者包括所有出生于 1945 年至 1965 年之间、在 2014 年 1 月 1 日至 2018 年 6 月 30 日之间接受 DAA 治疗的患者。数据分析于 2020 年 11 月完成，并在 2023 年进行了更新的敏感性分析。
使用酒精使用障碍识别测试-消耗（AUDIT-C）问卷和酒精使用障碍（AUD）的国际疾病分类，第九版和国际疾病分类和相关健康问题，第十版诊断的反应来生成酒精使用类别：无 AUD 的戒酒，有 AUD 的戒酒，低风险消耗，中风险消耗，高风险消耗或 AUD。
主要结局是 SVR，定义为 DAA 治疗完成后 12 周或更长时间内 HCV RNA 不可检测。使用多变量逻辑回归来估计与酒精类别相关的 SVR 的比值比（OR）和 95%置信区间（CI）。
在接受 DAA 治疗的 69229 名患者中（平均[SD]年龄，62.6[4.5]岁；67150 名男性[97.0%]；34655 名非西班牙裔白人个体[50.1%]；28094 名非西班牙裔黑人个体[40.6%]；58477 名 HCV 基因型 1 个体[84.5%]），65355 名（94.4%）达到 SVR。共有 32290 名（46.6%）患者无 AUD 戒酒，9192 名（13.3%）患者有 AUD 戒酒，13415 名（19.4%）患者低风险消耗，3117 名（4.5%）患者中风险消耗，11215 名（16.2%）患者高风险消耗或 AUD。在调整了潜在混杂因素后，在 SVR 方面，各酒精使用类别之间没有差异，即使是高风险消耗或 AUD 的患者也是如此（OR，0.95；95%CI，0.85-1.07）。纤维化-4 评分（P 交互值=0.30）衡量的肝纤维化分期无交互作用的证据。
在这项队列研究中，饮酒和 AUD 与 SVR 的可能性降低无关。根据酒精使用情况限制 DAA 治疗的机会，对患者造成了不必要的障碍，并对 HCV 消除目标提出了挑战。
