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治疗丙型肝炎患者的结局和成本的真实世界经验:来自德国丙型肝炎注册研究(DHC-R)的结果。

Real-world experience for the outcomes and costs of treating hepatitis C patients: Results from the German Hepatitis C-Registry (DHC-R).

机构信息

Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany.

Medizinische Klinik, Krankenhaus Nordwest, Frankfurt, Germany.

出版信息

Z Gastroenterol. 2023 May;61(5):489-503. doi: 10.1055/a-1852-5713. Epub 2022 Jul 15.

DOI:10.1055/a-1852-5713
PMID:35839795
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10162862/
Abstract

BACKGROUND & AIMS: With long-term consequences like the development of liver cirrhosis and hepatocellular carcinoma, chronic hepatitis C virus (HCV) infection is associated with a significant health burden. Information on HCV treatment outcomes and costs in routine care is still rare, especially for subgroups. The aim of this study was to analyse the treatment outcomes and costs of subgroups in routine care and to compare them over time with previous analyses.

METHODS

Data were derived from a noninterventional study including a subset of 10298 patients receiving DAAs with genotypes 1 and 3. Sociodemographic, clinical parameters and costs were collected using a web-based data recording system. The total sample was subdivided according to treatment regimen, cirrhosis status as well as present HIV infection and opioid substitution treatment (OST).

RESULTS

95% of all patients achieved SVR. Currently used DAA showed higher SVR-rates and less adverse events (AE) compared to former treatments. Concerning subgroups, cirrhotic patients, HIV-coinfected patients and OST patients showed lower but still high SVR-rates. In comparison, cirrhotic had considerably longer treatment duration and more frequent (serious) AE. Overall, average treatment costs were €48470 and costs per SVR were €51129; for currently used DAAs costs amounted to €30330 and costs per SVR to €31692. After the end of treatment, physical health is similar to the general population in all patients except cirrhotic. Mental health remains far behind in all subgroups, even for currently used DAA.

CONCLUSIONS

Over time, some relevant factors developed positively (SVR-rates, costs, treatment duration, adverse events, health-related quality of life (HRQoL)). Further research on HRQoL, especially on mental health, is necessary to evaluate the differences between subgroups and HRQoL over time and to identify influencing factors.

摘要

背景与目的

慢性丙型肝炎病毒(HCV)感染可导致肝硬化和肝细胞癌等长期后果,因此给患者带来了沉重的健康负担。在常规护理中,有关 HCV 治疗结果和成本的信息仍然很少,尤其是对于亚组患者。本研究旨在分析常规护理中各亚组的治疗结果和成本,并与之前的分析结果进行比较。

方法

本研究的数据来自一项非干预性研究,该研究纳入了接受基因型 1 和 3 的直接作用抗病毒药物(DAA)治疗的 10298 例患者。采用基于网络的数据记录系统收集患者的社会人口学、临床参数和成本数据。根据治疗方案、肝硬化状态、HIV 合并感染和阿片类药物替代治疗(OST)情况对整个样本进行细分。

结果

所有患者的 SVR 率均为 95%。目前使用的 DAA 与之前的治疗方法相比,SVR 率更高,不良反应(AE)更少。在亚组中,肝硬化、HIV 合并感染和 OST 患者的 SVR 率虽然较低,但仍很高。相比之下,肝硬化患者的治疗持续时间更长,AE 更频繁(严重)。总体而言,平均治疗费用为 48470 欧元,每例 SVR 的费用为 51129 欧元;目前使用的 DAA 的治疗费用为 30330 欧元,每例 SVR 的费用为 31692 欧元。治疗结束后,除肝硬化患者外,所有患者的生理健康状况均与普通人群相似。在所有亚组中,心理健康状况仍远远落后,即使是目前使用的 DAA 也是如此。

结论

随着时间的推移,一些相关因素有所改善(SVR 率、成本、治疗持续时间、AE、健康相关生活质量(HRQoL))。需要进一步研究 HRQoL,尤其是心理健康,以评估亚组之间以及随时间推移的 HRQoL 差异,并确定影响因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/fe6c47920aae/zfg-18525713_10-1055-a-1852-5713-i4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/9a0a5693568e/zfg-18525713_10-1055-a-1852-5713-i1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/c71080c5636e/zfg-18525713_10-1055-a-1852-5713-i2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/c89a701cbcf8/zfg-18525713_10-1055-a-1852-5713-i3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/fe6c47920aae/zfg-18525713_10-1055-a-1852-5713-i4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/9a0a5693568e/zfg-18525713_10-1055-a-1852-5713-i1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/c71080c5636e/zfg-18525713_10-1055-a-1852-5713-i2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/c89a701cbcf8/zfg-18525713_10-1055-a-1852-5713-i3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27ad/10162862/fe6c47920aae/zfg-18525713_10-1055-a-1852-5713-i4.jpg

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