Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Asian Pac J Cancer Prev. 2023 Feb 1;24(2):597-605. doi: 10.31557/APJCP.2023.24.2.597.
BACKGROUND & AIMS: The safety and efficacy of hepatitis C (HCV) direct-acting antivirals (DAAs) have been established in several real-world trials; however, some reports have claimed an association between DAAs and hepatocellular carcinoma (HCC) occurrence or aggressive behavior. We aimed to prospectively examine differences in de-novo HCC tumor behavior and overall survival (OS) in DAAs-treated versus HCV-untreated patients as measured by BCLC progression during a two-year follow-up period.
This multicenter cohort study recruited 523 patients with de-novo HCV-related HCC. After exclusion criteria were applied, 353 patients were placed into; Group 1, including 236 patients without a history of DAAs therapy, and Group 2 including 117 patients with de-novo HCC developed after receiving DAAs. Patients were then stratified in each group according to BCLC staging (Liver, 2018). All patients received standard of care management and were followed until death or a maximum of 2 years.
No statistically significant differences were observed between the two groups regarding tumor characteristics (number and size of lesions) and criteria for aggressiveness upon presentation. Among all BCLC stages, DAAs treated patients showed significantly lower baseline Fib4 values than DAA untreated patients in BCLC-0 stage (4.1 vs 7.7, p 0.019). No statistically significant differences were evident in HCC progression in the different BCLC stages at 12 and 24 months follow up periods (p 0.0718 and 0.279 respectively). Significantly better survival was recorded in Group 1 compared to Group 2 patients for BCLC stages C and D (p = 0.003 and 0.01, respectively).
HCC may develop at an earlier stage of liver disease after DAAs therapy. No defensive role was found for DAAs treatment in delaying HCC progression that occurs after viral eradication.
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几项真实世界试验已证实丙型肝炎（HCV）直接作用抗病毒药物（DAA）的安全性和有效性；然而，一些报告声称 DAA 与肝细胞癌（HCC）发生或侵袭性行为之间存在关联。我们旨在前瞻性地研究 DAA 治疗与 HCV 未治疗患者在两年随访期间通过 BCLC 进展衡量的新发性 HCC 肿瘤行为和总生存期（OS）的差异。
这项多中心队列研究招募了 523 例新发性 HCV 相关 HCC 患者。应用排除标准后，353 例患者被纳入研究：第 1 组包括 236 例无 DAA 治疗史的患者，第 2 组包括 117 例接受 DAA 治疗后新发生的 HCC 患者。然后根据 BCLC 分期（2018 年）将每组患者进一步分层。所有患者均接受标准治疗管理，并随访至死亡或最长 2 年。
两组患者在肿瘤特征（病变数量和大小）和就诊时侵袭性标准方面无统计学差异。在所有 BCLC 分期中，DAA 治疗患者在 BCLC-0 期的基线 Fib4 值明显低于 DAA 未治疗患者（4.1 比 7.7，p=0.019）。在 12 个月和 24 个月的随访期间，不同 BCLC 分期的 HCC 进展无统计学差异（p=0.0718 和 0.279 分别）。与 DAA 未治疗患者相比，BCLC 分期为 C 和 D 的患者的 DAA 治疗组 1 的生存率显著提高（p=0.003 和 0.01，分别）。
DAA 治疗后，HCC 可能在肝病的更早阶段发生。在病毒清除后发生的 HCC 进展中，未发现 DAA 治疗具有延迟作用。
