无干扰素治疗丙型肝炎病毒混合冷球蛋白血症：一项前瞻性、对照、临床和生活质量分析。

Interferon-free therapy in hepatitis C virus mixed cryoglobulinaemia: a prospective, controlled, clinical and quality of life analysis.

机构信息

Department of Experimental and Clinical Medicine and Department of Oncology, Interdepartmental Center for Systemic Manifestations of Hepatitis Viruses (MASVE), Azienda Ospedaliero-Universitaria Careggi (AOUC), Florence, Italy.

Division of Rheumatology, Department of Geriatric Medicine, Azienda Ospedaliero-Universitaria Careggi (AOUC), Florence, Italy.

出版信息

Aliment Pharmacol Ther. 2018 Aug;48(4):440-450. doi: 10.1111/apt.14845. Epub 2018 Jun 28.

DOI:10.1111/apt.14845

PMID:29952013

Abstract

BACKGROUND

Cryoglobulinaemic vasculitis (CV) is a lymphoproliferative disorder related to hepatitis C virus (HCV) infection; anti-viral therapy is the first therapeutic option. CV can be incapacitating, compromising the patients' quality of life (QoL). In a controlled study, interferon-based therapy was associated with a lower virological response in vasculitic patients than in patients without vasculitis. Limited, uncontrolled data on direct-acting anti-virals are available.

AIM

To evaluate safety, clinical efficacy, virological response and the impact of interferon-free treatment on QoL in HCV patients with and without mixed cryoglobulinaemia (MC).

METHODS

We prospectively studied HCV patients with cryoglobulinaemia (with vasculitis-CV- and without vasculitis-MC-) and without cryoglobulinaemia (controls), treated with direct-acting anti-virals. Hepato-virological parameters, CV clinical response and impact on QoL were assessed.

RESULTS

One hundred and eighty-two HCV patients were recruited (85 with CV, 54 with MC and 43 controls). A sustained virological response at 12 weeks (SVR12) was achieved in 166 (91.2%) patients (77/85 CV, 48/54 MC, 41/43 controls). In CV SVR patients, cryocrit levels progressively decreased and clinical response progressively improved, reaching 96.7%, 24 weeks after treatment. QoL, baseline physical and mental component summaries were lower in the CV group compared to the other groups (P < 0.05). Scores improved in all groups, and significantly in CV patients after SVR.

CONCLUSIONS

No significant differences in SVR rates were recorded between cryoglobulinaemic patients and controls and a high clinical and immunological efficacy was confirmed in CV, supporting the role of interferon-free therapy as the first therapeutic option. Interestingly, CV patients had worse baseline QoL than other HCV-positive groups and interferon-free therapy was effective in significantly increasing QoL, suggesting the important role of direct-acting anti-viral-based therapy in improving CV's individual and social burden.

摘要

背景

冷球蛋白血症性血管炎（CV）是一种与丙型肝炎病毒（HCV）感染相关的淋巴增生性疾病；抗病毒治疗是首选治疗方案。CV 可导致患者丧失能力，降低生活质量（QoL）。在一项对照研究中，与无血管炎的患者相比，基于干扰素的治疗在血管炎患者中病毒学应答较低。目前，有关直接作用抗病毒药物的有限、非对照数据可用。

目的

评估有和无混合性冷球蛋白血症（MC）的 HCV 患者接受无干扰素治疗的安全性、临床疗效、病毒学应答和对生活质量的影响。

方法

我们前瞻性研究了接受直接作用抗病毒药物治疗的冷球蛋白血症（伴血管炎-CV-和无血管炎-MC-）和无冷球蛋白血症（对照）的 HCV 患者。评估了肝病毒学参数、CV 临床应答和对生活质量的影响。

结果

共纳入 182 例 HCV 患者（85 例 CV、54 例 MC 和 43 例对照）。166 例（91.2%）患者获得了 12 周持续病毒学应答（SVR12）（77/85 CV、48/54 MC、41/43 对照）。在 CV SVR 患者中，冷球蛋白水平逐渐降低，临床应答逐渐改善，在治疗后 24 周达到 96.7%。与其他组相比，CV 组的生活质量、基线身体和精神成分综合评分较低（P<0.05）。所有组的评分均有所改善，且 CV 患者在 SVR 后显著改善。

结论

在冷球蛋白血症患者和对照组之间，SVR 率无显著差异，并且在 CV 中证实了高临床和免疫疗效，支持无干扰素治疗作为首选治疗方案。有趣的是，与其他 HCV 阳性组相比，CV 患者的基线生活质量更差，无干扰素治疗可显著提高生活质量，这表明直接作用抗病毒药物治疗在改善 CV 的个体和社会负担方面具有重要作用。