Inflammation-Immunopathology-Biotherapy Department (DHU i2B), Sorbonne Universités, UPMC Univ Paris 06, Paris, France INSERM, UMR_S 959, Paris, France CNRS, FRE3632, Paris, France Groupe Hospitalier Pitié-Salpêtrière, Department of Internal Medicine and Clinical Immunology, AP-HP, Paris, France.
Groupe Hospitalier Pitié-Salpétrière, Department of Virology, APHP, Paris, France.
Ann Rheum Dis. 2016 Oct;75(10):1777-82. doi: 10.1136/annrheumdis-2015-208339. Epub 2015 Nov 13.
Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinaemia vasculitis. Interferon-containing regimens are associated with important side effects and may exacerbate the vasculitis.
To evaluate safety and efficacy of an oral interferon-free regimen, sofosbuvir plus ribavirin, in HCV-cryoglobulinaemia vasculitis.
We enrolled 24 consecutive patients (median age of 56.5 years and 46% of women) with HCV-cryoglobulinaemia vasculitis. Sofosbuvir (400 mg/day) was associated with ribavirin (200-1400 mg/day), for 24 weeks. The primary efficacy end point was a complete clinical response of the vasculitis at the end of treatment (week 24).
Main features of HCV-cryoglobulinaemia vasculitis included purpura and peripheral neuropathy (67%), arthralgia (58%), glomerulonephritis (21%) and skin ulcers (12%). Twenty-one patients (87.5%) were complete clinical response at week 24. Complete clinical response was achieved in six (25%) patients at week 4, four (16.6%) at week 8, seven (29.2%) at week 12, three (12.5%) at week 16 and one (4.2%) at week 20. The cryoglobulin level decreased from 0.35 (0.16-0.83) at baseline to 0.15 (0.05-0.45) g/L at week 24. The C4 serum level increased from 0.10 (0.07-0.19) to 0.17 (0.09-0.23) g/L at week 24. Seventy-four per cent of patients had a sustained virological response at week 12 post treatment. The most common side effects were fatigue, insomnia and anaemia. Two serious adverse events were observed.
Sofosbuvir plus ribavirin combination was associated with a high rate of complete clinical response and a low rate of serious adverse events in HCV-cryoglobulinaemia vasculitis.
丙型肝炎病毒（HCV）是多数冷球蛋白血症血管炎的病因。含干扰素的方案与重要的副作用相关，并且可能加重血管炎。
评估无干扰素的口服治疗方案（索磷布韦加利巴韦林）在 HCV 冷球蛋白血症血管炎中的安全性和疗效。
我们纳入了 24 例连续的 HCV 冷球蛋白血症血管炎患者（中位年龄 56.5 岁，46%为女性）。索磷布韦（400mg/天）联合利巴韦林（200-1400mg/天）治疗 24 周。主要疗效终点是治疗结束（第 24 周）时血管炎的完全临床缓解。
HCV 冷球蛋白血症血管炎的主要特征包括紫癜和周围神经病（67%）、关节炎（58%）、肾小球肾炎（21%）和皮肤溃疡（12%）。21 例（87.5%）患者在第 24 周时达到完全临床缓解。4 例（16.6%）患者在第 4 周、7 例（29.2%）在第 8 周、3 例（12.5%）在第 12 周、1 例（4.2%）在第 20 周达到完全临床缓解。冷球蛋白水平从基线时的 0.35（0.16-0.83）g/L 降至第 24 周时的 0.15（0.05-0.45）g/L。C4 血清水平从基线时的 0.10（0.07-0.19）g/L 升高至第 24 周时的 0.17（0.09-0.23）g/L。74%的患者在治疗后 12 周时获得持续病毒学应答。最常见的不良反应是疲劳、失眠和贫血。观察到 2 例严重不良事件。
索磷布韦加利巴韦林联合治疗在 HCV 冷球蛋白血症血管炎中具有较高的完全临床缓解率和较低的严重不良事件发生率。
