索磷布韦联合维帕他韦治疗丙型肝炎肝硬化患者疗效及安全性分析

Sofosbuvir/velpatasvir plus ribavirin for patients with compensated and decompensated hepatitis C liver cirrhosis

目的分析应用索磷布韦(SOF)联合维帕他韦(VEL)治疗代偿期慢性丙型肝炎肝硬化(CHC-CLC)和失代偿期丙型肝炎肝硬化(CHC-DLC)患者的疗效及安全性,为临床决策提供参考依据。方法2020年3月~2022年3月我院肝病科诊治的CHC-CLC患者36例和CHC-DLC患者27例,所有患者接受SOF联合VEL治疗12 w,对于CHC-DLC患者,另联合利巴韦林治疗。分别记录治疗4 w时的早期病毒学应答率(EVR)、治疗结束时病毒学应答率(EOT)、停药后24周SVR(SVR24)和停药后48周SVR(SVR48)。结果CHC-CLC患者食管胃静脉曲张、肝性脑病、腹水发生率和血清胆红素水平显著低于CHC-DLC患者,差异有统计学意义(P<0.05),而外周血WBC、Hb、PLT及血清Alb和PTA显著高于CHC-DLC患者,差异有统计学意义(P<0.05);在随访结束时,CHC-DLC患者死亡3例(11.1%);CHC-CLC患者EVR、EOT、SVR24和SVR48分别为94.4%、100.0%、100.0%和100.0%,优于CHC-DLC患者【分别为83.3%、100.0%、83.3%和75.0%(P<0.05)】;CHC-CLC患者血清ALT水平为32(18,40)U/L,外周血WBC计数为4.1(3.2,7.7)×10^(9)/L,血小板计数为104(90,381)×10^(9)/L,与CHC-DLC患者【分别为55(35,62)U/L、3.0(2.7,5.0)×10^(9)/L和72(54,115)×10^(9)/L,P<0.05】比,差异显著;在服药期间,4例CHC-CLC和8例CHC-DLC患者发生不良反应,主要为腹胀、食欲不振、乏力、搏动性头痛和暂时性血压升高。结论应用SOF联合VEL的DAAs治疗方案治疗CHC-CLC或CHC-DLC患者均具有很好的疗效,且安全。

Objective The aim of this study was to investigate the efficacy and safety of sofosbuvir(SOF)and velpatasvir(VEL)plus or not plus ribavirin in the treatment of patients with chronic hepatitis C-related compensated liver cirrhosis(CHC-CLC)and decompensated liver cirrhosis(CHC-DLC).Methods 36 patients with CHC-CLC and 27 patients with CHC-DLC were enrolled in this study between March 2020 and March 2022,and all patients received SOF and VEL and the patients with CHC-DLC were added with ribavirin for 12 weeks.The patients were followed-up for 48 weeks.The early virological response rate(EVR),the end of treatment response(EOT),the sustained virological response at 24 weeks(SVR24)and the SVR at 48 weeks(SVR48)after the discontinuation of the regimen were recorded.Results The incidences of esophageal varices,hepatic encephalopathy,ascites and hyperbilibubinemia in patients with CHC-CLC were much lower than(P<0.05),while the peripheral white blood cell(WBC)counts,hemoglobin concentration,platelet counts,serum albumin levels and prothrombin time activity were significantly higher than in patients with CHC-DLC(P<0.05);at the end of 48 week follow-up,three patients(11.1%)with CHC-DLC died;the EVR,EOT,SVR24 and SVR48 in patients with CHC-CLC were 94.4%,100.0%,100.0%and 100.0%,superior to 83.3%,100.0%,83.3%and 75.0%(P<0.05)in patients with CHC-DLC;in patients with CHC-CLC,serum alanine aminotransaminase level was 32(18,40)U/L,peripheral WBC count was 4.1(3.2,7.7)×10^(9)/L,platelet count was 104(90,381)×10^(9)/L,all significantly different as compared to[55(35,62)U/L,3.0(2.7,5.0)×10^(9)/L and 72(54,115)×10^(9)/L,respectively,P<0.05]in patients with CHC-DLC;during the antiviral treatment period,the untoward reactions were found in 4 patients with CHC-CLC and in 8 patients with CHC-DLC,including abdominal distension,anorexia,fatigue,throbbing headache and transient hypertension,which didn’t influence the treatment.Conclusion The oral administration of SOF and VEL plus or not plus ribavirin in treatment of patients with with CHC-CLC and CHC-DLC is efficacious and safety,which warrants further clinical investigations.