索磷布韦/维帕他韦/伏西瑞韦治疗既往直接抗病毒药物治疗失败的慢性丙型肝炎患者的有效性和安全性

Efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous direct-acting antiviral agent failure

目的评估真实世界中索磷布韦/维帕他韦/伏西瑞韦(SOF/VEL/VOX)用于既往接受直接抗病毒药物(DAA)治疗失败的慢性丙型肝炎患者的有效性和安全性。方法回顾性研究纳入2020年6月—2023年6月于南京市第二医院、无锡市第五人民医院和镇江市第三人民医院就诊的既往接受DAA抗病毒治疗失败并予以SOF/VEL/VOX(400 mg/100 mg/100 mg/片,1片/d)治疗12周的慢性丙型肝炎患者,观察治疗结束后12周持续病毒学应答(SVR12)情况,并评估生化学指标变化和不良反应发生情况,以评价药物的安全性。计量资料两组间比较采用配对t检验。结果共入组36例患者,非肝硬化27例,代偿期肝硬化9例,既往2次及以上DAA治疗失败4例。2例患者完成治疗后失访,余34例患者(94.4%)达到SVR12。入组的36例患者中,最常见的不良事件为瘙痒、恶心、疲劳和头痛;1例(2.78%)患者出现严重不良事件;未出现导致治疗药物停用或患者死亡的不良事件。结论SOF/VEL/VOX用于既往接受DAA治疗失败的丙型肝炎患者的挽救性治疗有较高的SVR12,且耐受性和安全性良好。

Objective To investigate the efficacy and safety of sofosbuvir/velpatasivr/voxilaprevir(SOF/VEL/VOX)in patients with HCV infection experiencing failure in previous direct-acting antiviral agent(DAA)therapy.Methods A retrospective analysis was performed for the chronic hepatitis C patients who experienced failure in previous DAA antiviral therapy and were treated with SOF/VEL/VOX(400 mg/100 mg/100 mg/tablet,1 tablet/day)for 12 weeks in Nanjing Second Hospital,Wuxi Fifth People’s Hospital,and The Third People’s Hospital of Zhenjiang from June 2020 to June 2023.Sustained virological response at 12 weeks(SVR12)was observed after the end of treatment,and the changes in biochemical parameters and the incidence rate of adverse reactions were assessed to evaluate drug safety.The paired t-test was used for comparison of continuous data between two groups.Results A total of 36 patients were enrolled,among whom there were 27 non-liver cirrhosis patients and 9 patients with compensated liver cirrhosis,and 4 patients experienced failure in the previous two or more sessions of DAA therapy.Two patients were lost to follow-up after treatment,and the remaining 34 patients(34/36,94.4%)achieved SVR12.Among the 36 patients enrolled,the most common adverse events were pruritus,nausea,fatigue,and headache,and one patient(2.78%)experienced serious adverse events;there were no adverse events that resulted in the discontinuation of therapeutic agents or the death of patients.Conclusion For chronic hepatitis C patients who experience failure in previous DAA therapy,SOF/VEL/VOX salvage therapy has a relatively high rate of SVR12,with good tolerability and safety.