Chang Shao-Hsuan, Cabrera Roniel, Heo Jihaeng, Park Chanhyun, Guo Jingchuan, Park Haesuk
Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
Division of Gastroenterology, Hepatology, and Nutrition, College of Medicine, University of Florida, Gainesville, Florida, USA.
Clin Pharmacol Ther. 2025 Apr;117(4):1030-1038. doi: 10.1002/cpt.3481. Epub 2024 Nov 3.
The association between direct-acting antiviral (DAA) treatment and hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) is currently unclear. Hence, we aim to assess the association between DAA treatment and mortality rate among Medicare beneficiaries with HCV-related HCC. This retrospective cohort study screened 19,813 adults in 2013-2019 Surveillance, Epidemiology, and End Results data linked with Medicare data. Patients with HCV-related HCC initiating DAA therapy after their first HCC diagnosis were compared with patients with HCV-related HCC who received no HCV treatment. After inverse probability treatment weighting, multivariable Cox proportional hazards models compared mortality rates between the groups. Subgroup and sensitivity analyses were based on HCC stage (early vs. advanced), type of HCC treatment (curative, palliative, none), and DAA treatment duration. In total 3,777 patients with HCV-related HCC were identified (mean age: 68.2 years, 75.2% male, 61.8% White), of whom 19% initiated DAA therapy. Crude incidence mortality rates were 17.9 and 90.7 deaths per 100 person-years in the DAA and HCV-untreated groups, respectively. Cox regression models indicated that DAA therapy was associated with decreased risk of all-cause mortality (adjusted hazard ratio, 0.33; 95% CI 0.31-0.36). Median survival time was 45.7 (95% CI 40.9-57.9) months in the DAA group and 7.7 (95% CI 7.3-8.2) months in the HCV-untreated group (P < 0.001). All subgroup and sensitivity analyses were consistent with the main analyses. DAA therapy was associated with survival benefits for patients with HCV-related HCC regardless of the stage or type of HCC treatment and should not be withheld from this population of Medicare beneficiaries.
直接抗病毒药物（DAA）治疗与丙型肝炎病毒（HCV）相关肝细胞癌（HCC）之间的关联目前尚不清楚。因此，我们旨在评估DAA治疗与HCV相关HCC的医疗保险受益人的死亡率之间的关联。这项回顾性队列研究筛选了2013 - 2019年监测、流行病学和最终结果数据中与医疗保险数据相关联的19,813名成年人。将首次诊断为HCC后开始DAA治疗的HCV相关HCC患者与未接受HCV治疗的HCV相关HCC患者进行比较。在逆概率治疗加权后，多变量Cox比例风险模型比较了两组之间的死亡率。亚组分析和敏感性分析基于HCC分期（早期与晚期）、HCC治疗类型（治愈性、姑息性、无）以及DAA治疗持续时间。总共识别出3777例HCV相关HCC患者（平均年龄：68.2岁，75.2%为男性，61.8%为白人），其中19%开始了DAA治疗。DAA治疗组和未接受HCV治疗组的粗发病率死亡率分别为每100人年17.9例和90.7例死亡。Cox回归模型表明，DAA治疗与全因死亡率风险降低相关（调整后的风险比，0.33；95%可信区间0.31 - 0.36）。DAA治疗组的中位生存时间为45.7（95%可信区间40.9 - 57.9）个月，未接受HCV治疗组为7.7（95%可信区间7.3 - 8.2）个月（P < 0.001）。所有亚组分析和敏感性分析结果均与主要分析一致。无论HCC的分期或治疗类型如何，DAA治疗都与HCV相关HCC患者的生存获益相关，不应拒绝为这一医疗保险受益人群提供DAA治疗。
