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直接作用抗病毒治疗对新出现的丙型肝炎相关失代偿性肝硬化的人群影响:一项全国性的记录链接研究。

Population impact of direct-acting antiviral treatment on new presentations of hepatitis C-related decompensated cirrhosis: a national record-linkage study.

机构信息

Centre for Living, School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK

Blood Borne Virus & Sexually Transmitted Infections Team, Health Protection Scotland, Glasgow, UK.

出版信息

Gut. 2020 Dec;69(12):2223-2231. doi: 10.1136/gutjnl-2019-320007. Epub 2020 Mar 26.

Abstract

OBJECTIVE

Population-based studies demonstrating the clinical impact of interferon-free direct-acting antiviral (DAA) therapies are lacking. We examined the impact of the introduction of DAAs on HCV-related decompensated cirrhosis (DC) through analysis of population-based data from Scotland.

DESIGN

Through analysis of national surveillance data (involving linkage of HCV diagnosis and clinical databases to hospital and deaths registers), we determined i) the scale-up in the number of patients treated and achieving a sustained viral response (SVR), and ii) the change in the trend of new presentations with HCV-related DC, with the introduction of DAAs.

RESULTS

Approximately 11 000 patients had been treated in Scotland over the 8-year period 2010/11 to 2017/18. The scale-up in the number of patients achieving SVR between the pre-DAA and DAA eras was 2.3-fold overall and 5.9-fold among those with compensated cirrhosis (the group at immediate risk of developing DC). In the pre-DAA era, the annual number of HCV-related DC presentations increased 4.6-fold between 2000 (30) and 2014 (142). In the DAA era, presentations decreased by 51% to 69 in 2018 (and by 67% among those with chronic infection at presentation), representing a significant change in trend (rate ratio 0.88, 95% CI 0.85 to 0.90). With the introduction of DAAs, an estimated 330 DC cases had been averted during 2015-18.

CONCLUSIONS

National scale-up in interferon-free DAA treatment is associated with the rapid downturn in presentations of HCV-related DC at the population-level. Major progress in averting HCV-related DC in the short-term is feasible, and thus other countries should strive to achieve the same.

摘要

目的

缺乏基于人群的研究来证明无干扰素直接作用抗病毒 (DAA) 治疗的临床影响。我们通过分析苏格兰基于人群的数据来研究 DAA 的引入对丙型肝炎相关失代偿性肝硬化 (DC) 的影响。

设计

通过对国家监测数据(涉及丙型肝炎诊断和临床数据库与医院和死亡登记的链接)进行分析,我们确定了 i)接受治疗且获得持续病毒学应答 (SVR) 的患者数量的增加,以及 ii)随着 DAA 的引入,丙型肝炎相关 DC 新发病例趋势的变化。

结果

在 2010/11 年至 2017/18 年的 8 年期间,苏格兰约有 11000 名患者接受了治疗。在 DAA 时代之前和之后,获得 SVR 的患者数量的增加总体上增加了 2.3 倍,在代偿性肝硬化(即立即有发展为 DC 风险的患者)患者中增加了 5.9 倍。在 DAA 时代之前,2000 年(30 例)至 2014 年(142 例)丙型肝炎相关 DC 就诊人数每年增加 4.6 倍。在 DAA 时代,2018 年就诊人数减少了 51%至 69 例(在初诊时患有慢性感染的患者中减少了 67%),趋势发生了显著变化(率比 0.88,95%CI 0.85 至 0.90)。随着 DAA 的引入,2015-18 年期间估计有 330 例 DC 病例得到避免。

结论

无干扰素 DAA 治疗的全国性扩大与丙型肝炎相关 DC 在人群层面上的迅速减少有关。在短期内避免丙型肝炎相关 DC 取得重大进展是可行的,因此其他国家也应努力实现这一目标。

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