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直接作用抗病毒药物治疗慢性丙型肝炎病毒感染的真实世界疗效:仅部分改善健康相关生活质量——德国丙型肝炎注册研究(DHC-R)的结果。

Only partial improvement in health-related quality of life after treatment of chronic hepatitis C virus infection with direct acting antivirals in a real-world setting-results from the German Hepatitis C-Registry (DHC-R).

机构信息

Hannover Medical School, Hannover, Germany.

Diabetes-Klinik Bad Mergentheim, Bad Mergentheim, Germany.

出版信息

J Viral Hepat. 2021 Aug;28(8):1206-1218. doi: 10.1111/jvh.13546. Epub 2021 Jun 8.

DOI:10.1111/jvh.13546
PMID:34003549
Abstract

Improvement of health-related quality of life (HRQoL) is frequently reported as a benefit when treating hepatitis C virus infection (HCV) with direct acting antivirals (DAA). As most of the available data were obtained from clinical trials, limited generalizability to the real-world population might exist. This study aimed to investigate the impact of DAA therapy on changes in HRQoL in a real-world setting. HRQoL of 1180 participants of the German Hepatitis C-Registry was assessed by Short-Form 36 (SF-36) questionnaires. Scores at post-treatment weeks 12-24 (FU12/24) were compared to baseline (BL). Changes of ≥2.5 in mental and physical component summary scores (MCS and PCS) were defined as a minimal clinical important difference (MCID). Potential predictors of HRQoL changes were analysed. Overall, a statistically significant increase in HRQoL after DAA therapy was observed, that was robust among various subgroups. However, roughly half of all patients failed to achieve a clinically important improvement in MCS and PCS. Low MCS (p < .001, OR = 0.925) and PCS (p < .001, OR = 0.899) BL levels were identified as predictors for achieving a clinically important improvement. In contrast, presence of fatigue (p = .023, OR = 1.518), increased GPT levels (p = .005, OR = 0.626) and RBV containing therapy regimens (p = .001, OR = 1.692) were associated with a clinically important decline in HRQoL after DAA therapy. In conclusion, DAA treatment is associated with an overall increase of HRQoL in HCV-infected patients. Nevertheless, roughly half of the patients fail to achieve a clinically important improvement. Especially patients with a low HRQoL seem to benefit most from the modern therapeutic options.

摘要

直接作用抗病毒药物(DAA)治疗丙型肝炎病毒(HCV)感染常被报道可改善健康相关生活质量(HRQoL)。由于大多数可用数据来自临床试验,因此其对真实人群的推广可能存在局限性。本研究旨在调查 DAA 治疗对真实环境中 HRQoL 变化的影响。德国丙型肝炎登记处的 1180 名参与者通过简短形式 36 项问卷(SF-36)进行 HRQoL 评估。将治疗后 12-24 周(FU12/24)的评分与基线(BL)进行比较。心理和生理成分综合评分(MCS 和 PCS)的变化≥2.5 定义为最小临床重要差异(MCID)。分析了 HRQoL 变化的潜在预测因素。总体而言,在 DAA 治疗后观察到 HRQoL 显著增加,且在各种亚组中均稳健。然而,大约一半的患者在 MCS 和 PCS 上未达到临床重要改善。低 MCS(p<.001,OR=0.925)和 PCS(p<.001,OR=0.899)BL 水平被确定为实现临床重要改善的预测因素。相反,疲劳的存在(p=.023,OR=1.518)、GPT 水平升高(p=.005,OR=0.626)和包含 RBV 的治疗方案(p=.001,OR=1.692)与 DAA 治疗后 HRQoL 的临床重要下降相关。总之,DAA 治疗与 HCV 感染患者的 HRQoL 总体提高相关。然而,大约一半的患者未达到临床重要改善。特别是 HRQoL 较低的患者似乎从现代治疗选择中获益最大。

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