Department of Internal Medicine and Clinical Immunology, AP-HP, Hôpital Pitié-Salpétrière, DHU I2B, Immunopathology, Inflammation, Biotherapy, Paris, France; Université Pierre et Marie Curie, Paris VI, UMR CNRS 7211, INSERM U959, Hôpital Pitié-Salpétrière, Paris, France.
Department of Biostatistics, Hôpital Saint-Louis, Paris, France.
J Hepatol. 2015 Jan;62(1):24-30. doi: 10.1016/j.jhep.2014.08.015. Epub 2014 Aug 15.
BACKGROUND & AIMS: The aim of this study was to analyse the safety and efficacy of the PegIFNα/ribavirin/protease inhibitor combination in severe and/or refractory hepatitis C virus (HCV)-mixed cryoglobulinemia (MC) vasculitis.
This prospective cohort study included 30 patients (median age 59 years [53-66] and 57% of women) with HCV-MC vasculitis. PegIFNα/ribavirin (for 48 weeks) was associated with telaprevir (375 mg three times daily, for 12 weeks, [n = 17]) or boceprevir (800 mg three times daily, for 44 weeks, (n = 13]).
Twenty three patients (76.7%) were non-responders to previous antiviral therapy. At week 72, twenty patients (66.7%) were complete clinical and sustained virological responders. The cryoglobulin level decreased from 0.45 to 0 g/L (p<0.0001) and the C4 level increased from 0.09 to 0.14 g/L (p = 0.017). Complete clinical responders had a higher frequency of purpura (16/20 [80%] vs. 4/10 [40%], p = 0.045), and a trend towards lower frequency of neuropathy (9/20 (45%) vs. 8/10 [80%], p = 0.12) compared with partial responders. Serious adverse events occurred in 14 patients (46.6%) during the 72 weeks of follow-up. Twenty eight patients (93.3%) received erythropoietin, 14 (46.6%) had red blood cell transfusion and 2 (6.6%) received granulocyte stimulating agent. The baseline factors associated with serious adverse events included liver fibrosis (p = 0.045) and a low platelet count (p = 0.021).
The PegIFNα/ribavirin/protease inhibitor combination is highly effective in severe and/or refractory HCV-MC at the cost of frequent side effects. Baseline platelet count and liver fibrosis are useful in guiding treatment decisions.
本研究旨在分析聚乙二醇干扰素α/利巴韦林/蛋白酶抑制剂联合方案治疗严重和/或难治性丙型肝炎病毒（HCV）混合性冷球蛋白血症（MC）血管炎的安全性和疗效。
这是一项前瞻性队列研究，纳入了 30 例 HCV-MC 血管炎患者（中位年龄 59 岁[53-66]岁，57%为女性）。聚乙二醇干扰素α/利巴韦林（48 周）联合特拉匹韦（375mg，每日 3 次，12 周[17 例]）或博赛匹韦（800mg，每日 3 次，44 周[13 例]）。
23 例（76.7%）患者对既往抗病毒治疗无应答。在第 72 周时，20 例（66.7%）患者达到完全临床和持续病毒学应答。冷球蛋白水平从 0.45g/L 降至 0g/L（p<0.0001），C4 水平从 0.09g/L 升至 0.14g/L（p=0.017）。完全临床应答者紫癜的发生率更高（20/20 [80%] vs. 10/10 [40%]，p=0.045），神经病变的发生率更低（20/20 [45%] vs. 10/10 [80%]，p=0.12）。在 72 周的随访期间，14 例（46.6%）患者发生严重不良事件。28 例（93.3%）患者接受了促红细胞生成素治疗，14 例（46.6%）患者接受了红细胞输注，2 例（6.6%）患者接受了粒细胞集落刺激因子治疗。与严重不良事件相关的基线因素包括肝纤维化（p=0.045）和血小板计数低（p=0.021）。
聚乙二醇干扰素α/利巴韦林/蛋白酶抑制剂联合方案对严重和/或难治性 HCV-MC 非常有效，但副作用频繁。基线血小板计数和肝纤维化有助于指导治疗决策。
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