Pereira Guedes Tiago, Fragoso Pedro, Lemos Carolina, Garrido Mónica, Silva Joana, Falcão Daniela, Maia Luís, Moreira Teresa, Manuel Ferreira José, Pedroto Isabel
Department of Gastroenterology, Centro Hospitalar Universitário do Porto, Porto, Portugal.
Instituto de Ciências Biomédicas Abel Salazar, Universidade do Porto, Porto, Portugal.
GE Port J Gastroenterol. 2020 Apr;27(3):149-159. doi: 10.1159/000503074. Epub 2019 Oct 10.
Direct-acting antivirals (DAA) have revolutionized hepatitis C treatment, with high sustained virological response (SVR) rates reported, even in historically difficult-to-treat groups. SVR is associated with a decreased risk of hepatocellular carcinoma (HCC), need for transplantation, and overall and liver-related mortality. Data from real-life cohorts on the medium- to long-term outcomes of patients with advanced liver disease and DAA-induced SVR are still missing.
To report and analyze the long-term outcomes of DAA-induced SVR in a real-life cohort of patients with advanced liver disease.
In this retrospective, longitudinal, single-center study, we collected data from patients with chronic hepatitis C infection and advanced liver disease (cirrhosis or advanced fibrosis) that had initiated DAA treatment between February 2015 and January 2017.
A total of 237 patients were included. A treatment completion rate of 98.7% and an SVR rate of 97.8% (intention to treat: 96.6%) were found. Of the 229 patients with SVR, 67.2% were cirrhotic (64.2% Child-Pugh class A; 3.1% Child-Pugh class B) and 32.8% had stage F3 fibrosis, with an average follow-up of 28 months. The overall mortality rate was 19/1,000 person-years and the liver-related mortality rate was 9.5/1,000 person-years. The hepatic decompensation incidence rate was 25/1,000 person-years and the HCC incidence rate was 11.6/1,000 person-years. There was a sustained increase in serum platelet values during up to 2 years of follow-up. A history of pretreatment decompensation and baseline platelet and albumin values were significantly associated with the occurrence of adverse liver events after the end of treatment.
A DAA-induced SVR remains durable and is associated with an excellent clinical prognosis in patients with compensated advanced liver disease and with improvement or disease stabilization in decompensated patients. SVR is associated with a low risk of - yet does not prevent - HCC occurrence or disease progression, especially in the presence of other causes of liver injury. It is recommended that these patients be kept under surveillance.
直接抗病毒药物（DAA）彻底改变了丙型肝炎的治疗方式，据报道其持续病毒学应答（SVR）率很高，即使在历来难以治疗的人群中也是如此。SVR与肝细胞癌（HCC）风险降低、移植需求以及全因死亡率和肝脏相关死亡率降低相关。关于晚期肝病患者和DAA诱导的SVR的中长期结局的真实队列数据仍然缺失。
报告并分析晚期肝病患者真实队列中DAA诱导的SVR的长期结局。
在这项回顾性、纵向、单中心研究中，我们收集了2015年2月至2017年1月期间开始接受DAA治疗的慢性丙型肝炎感染和晚期肝病（肝硬化或晚期纤维化）患者的数据。
共纳入237例患者。治疗完成率为98.7%，SVR率为97.8%（意向性治疗：96.6%）。在229例获得SVR的患者中，67.2%为肝硬化患者（64.2%为Child-Pugh A级；3.1%为Child-Pugh B级），32.8%为F3期纤维化患者，平均随访28个月。总死亡率为19/1000人年，肝脏相关死亡率为9.5/1000人年。肝失代偿发生率为25/1000人年，HCC发生率为11.6/1000人年。在长达2年的随访期间，血清血小板值持续升高。治疗前失代偿史以及基线血小板和白蛋白值与治疗结束后不良肝脏事件的发生显著相关。
DAA诱导的SVR仍然持久，在代偿性晚期肝病患者中与良好的临床预后相关，在失代偿患者中与病情改善或稳定相关。SVR与HCC发生或疾病进展的低风险相关，但不能预防，尤其是在存在其他肝损伤原因的情况下。建议对这些患者进行监测。
