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AGA 临床实践更新:口服直接作用抗病毒药物治疗慢性丙型肝炎感染与肝细胞癌的相互作用:专家综述。

AGA Clinical Practice Update on Interaction Between Oral Direct-Acting Antivirals for Chronic Hepatitis C Infection and Hepatocellular Carcinoma: Expert Review.

机构信息

Division of Digestive and Liver Diseases, UT Southwestern Medical Center, Dallas, Texas.

Yale Liver Center and Section of Digestive Diseases; Yale University School of Medicine, New Haven, Connecticut.

出版信息

Gastroenterology. 2019 Jun;156(8):2149-2157. doi: 10.1053/j.gastro.2019.02.046. Epub 2019 Mar 13.

Abstract

DESCRIPTION

The purpose of this clinical practice update is to evaluate the evidence describing the interaction between direct-acting antiviral (DAA) therapy for hepatitis and hepatocellular carcinoma (HCC) with regard to HCC incidence, HCC recurrence, and DAA efficacy, and to summarize best practice advice regarding HCC surveillance and timing of DAA therapy.

METHODS

The recommendations outlined in this expert review are based on available published evidence, including observational studies and systematic reviews, and incorporates expert opinion where applicable. BEST PRACTICE ADVICE 1: DAA treatment is associated with a reduction in the risk of incident HCC. The relative risk reduction is similar in patients with and without cirrhosis. BEST PRACTICE ADVICE 2: Patients with advanced liver fibrosis (F3) or cirrhosis should receive surveillance imaging before initiating DAA treatment. BEST PRACTICE ADVICE 3: Patients with advanced liver fibrosis (F3) or cirrhosis at the time of DAA treatment represent the highest-risk group for HCC after DAA-induced sustained virologic response. These patients should stay in HCC surveillance. BEST PRACTICE ADVICE 4: HCC surveillance should be performed using ultrasound with or without α-fetoprotein every 6 months. Current data do not support shorter surveillance intervals or the use of alternative surveillance modalities. BEST PRACTICE ADVICE 5: Future studies may show a reduction in HCC risk over time after DAA-induced sustained virologic response. However, in the interim, HCC surveillance should continue indefinitely if patients are otherwise eligible for potentially curative therapy. BEST PRACTICE ADVICE 6: The presence of active HCC is associated with a small but statistically significant decrease in sustained virologic response with DAA therapy. BEST PRACTICE ADVICE 7: Patients with HCC who are eligible for potentially curative therapy with liver resection or ablation should defer DAA therapy until after HCC treatment is completed. BEST PRACTICE ADVICE 8: Timing of DAA therapy for patients with HCC who are listed for liver transplantation should be determined with consideration of median wait times, availability of hepatitis C virus-positive organs, and degree of liver dysfunction. BEST PRACTICE ADVICE 9: There are insufficient data evaluating benefits and cost-effectiveness of DAA therapy in patients with active intermediate or advanced HCC. Decisions regarding DAA treatment in these patients should be considered in light of HCC tumor burden, degree of liver dysfunction, life expectancy, and patient preferences. BEST PRACTICE ADVICE 10: There are no conclusive data that DAA therapy is associated with increased or decreased risk, differential time to recurrence, or aggressiveness of recurrent HCC in patients with complete response to HCC therapy. BEST PRACTICE ADVICE 11: DAA therapy should not be withheld from patients with complete response to HCC therapy; however, DAA therapy can be deferred 4-6 months to confirm response to HCC therapy. BEST PRACTICE ADVICE 12: Patients with complete response to HCC therapy who are treated with DAAs have a continued risk of HCC recurrence and require HCC surveillance, which should be conducted indefinitely with dynamic contrast-enhanced computed tomography or magnetic resonance imaging every 3-6 months. Current data do not support more frequent surveillance in these patients. This Clinical Practice Update was produced by the AGA Institute.

摘要

描述

本临床实践更新旨在评估直接作用抗病毒 (DAA) 治疗与肝癌 (HCC) 发生率、HCC 复发和 DAA 疗效相关的证据,并总结关于 HCC 监测和 DAA 治疗时机的最佳实践建议。

方法

本专家综述中概述的建议基于现有的已发表证据,包括观察性研究和系统评价,并在适用的情况下纳入专家意见。最佳实践建议 1:DAA 治疗与 HCC 发生率降低相关。在有或没有肝硬化的患者中,相对风险降低是相似的。最佳实践建议 2:有进展性肝纤维化 (F3) 或肝硬化的患者应在开始 DAA 治疗前进行影像学监测。最佳实践建议 3:在 DAA 治疗时患有进展性肝纤维化 (F3) 或肝硬化的患者是 DAA 诱导持续病毒学应答后 HCC 风险最高的群体。这些患者应继续进行 HCC 监测。最佳实践建议 4:HCC 监测应使用超声联合或不联合甲胎蛋白每 6 个月进行一次。目前的数据不支持缩短监测间隔或使用替代监测方式。最佳实践建议 5:未来的研究可能会显示 DAA 诱导持续病毒学应答后 HCC 风险随时间降低。然而,在此期间,如果患者有资格接受潜在的根治性治疗,则应无限期继续 HCC 监测。最佳实践建议 6:存在活动性 HCC 与 DAA 治疗的持续病毒学应答率略有但具有统计学意义的降低相关。最佳实践建议 7:有资格接受肝切除术或消融术进行潜在根治性治疗的 HCC 患者应推迟 DAA 治疗,直到 HCC 治疗完成。最佳实践建议 8:对于等待肝移植的 HCC 患者,DAA 治疗的时机应考虑中位等待时间、丙型肝炎病毒阳性器官的可用性以及肝功能障碍程度。最佳实践建议 9:目前尚无数据评估 DAA 治疗在活动性中或晚期 HCC 患者中的获益和成本效益。应根据 HCC 肿瘤负荷、肝功能障碍程度、预期寿命和患者偏好,考虑对这些患者进行 DAA 治疗的决策。最佳实践建议 10:目前尚无确凿数据表明 DAA 治疗与 HCC 治疗完全缓解患者的 HCC 复发风险增加或降低、复发时间差异或复发 HCC 的侵袭性相关。最佳实践建议 11:不应因 HCC 治疗完全缓解而拒绝 HCC 治疗完全缓解患者的 DAA 治疗;然而,可以推迟 4-6 个月使用 DAA 治疗以确认 HCC 治疗的反应。最佳实践建议 12:接受 HCC 治疗完全缓解的患者继续存在 HCC 复发的风险,需要进行 HCC 监测,应使用动态对比增强计算机断层扫描或磁共振成像每 3-6 个月进行一次监测。目前的数据不支持这些患者更频繁的监测。本临床实践更新由 AGA 研究所制作。

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