索磷布韦/维帕他韦治疗基因3型慢性丙型肝炎和肝硬化患者的临床疗效
Clinical effect of sofosbuvir-velpatasvir on treatment of patients with genotype 3 chronic hepatic C and liver cirrhosis
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摘要:目的 探讨索磷布韦/维帕他韦(SOF/VEL)联合或不联合利巴韦林(RBV)治疗基因3型(GT3)慢性丙型肝炎(CHC)和肝硬化患者的疗效及安全性。方法 选取2018年6月-2023年3月新疆维吾尔自治区中医医院、新疆和田地区传染病专科医院和新疆玛纳斯县人民医院收治的230例GT3型CHC和肝硬化患者为研究对象, 观察SOF/VEL单药或联合RBV方案治疗12~24周的临床疗效, 分析高灵敏丙肝RNA(HCV RNA)、血常规、肝肾功能、肝纤维化无创诊断等指标及治疗结束后12周持续病毒性应答率(SVR12)。结果 纳入患者平均年龄为(42.31±11.18)岁, 男性占66.52%, GT3a 137例, GT3b 93例；CHC 183例、肝硬化代偿期(CC)44例、失代偿期(DCC)3例；HCV单独感染189例, HCV/HIV合并感染33例, HBV/HCV合并感染6例, HBV/HCV/HIV三重感染2例。230例患者的总体SVR12为99.57%, 其中GT3a型与GT3b型患者SVR12分别为100.00%和98.92%；CHC、CC及DCC患者的SVR12分别为99.45%、100.00%、100.00%。HCV单独感染、HCV/HIV、HBV/HCV、HBV/HCV/HIV患者SVR12分别为99.47%、100.00%、100.00%、100.00%；直接抗病毒药物(DAAs)治疗期间患者未因药物不良反应终止治疗；1例患者因未规律服用DAAs药物导致复发。结论 以SOF/VEL单药或联合RBV方案治疗基因3型CHC和肝硬化患者的病毒学应答率高, 且安全性好。Abstract:OBJECTIVE To explore the efficacy and safety of sofosbuvir-velpatasvir (SOF/VEL) combined with or without ribavirin (RBV) in treatment of the patients with genotype 3 (GT3) chronic hepatitis C (CHC) and liver cirrhosis.METHODS Totally 230 patients with CT3 CHC and liver cirrhosis who were treated in Traditional Chinese Hospital of Xinjiang Uygur Autonomous Region，Xinjiang Hetian Specialized Hospital of Infectious Diseases and Xinjiang Manasi County People′s Hospital from Jun. 2018 to Mar. 2023 were recruited as the research subjects. The clinical curative effects were observed after the subjects were treated with single SOF-VEL or the combination with RBV for 12 to 24 weeks. The indexes including high-sensitivity hepatitis C RNA (HCV RNA)，blood routine indexes，liver function indexes and noninvasive diagnosis indexes for liver fibrosis were observed，and the sustained virological response 12 weeks after the treatment (SVR12) was analyzed.RESULTS The mean age of the enrolled patients was (42.31±11.18) years old，the male patients accounted for 66.52%，and there were 137 cases of GT3a and 93 cases of GT3b 93, there were 183 cases of CHC，44 cases of compensated cirrhosis (CC) and 3 cases of decompensated cirrhosis (DCC). There were 189 cases of single HCV infection，33 cases of mixed infections of HCV and HIV，6 cases of mixed infections of HBV/HCV and 2 cases of triple infections of HBV/HCV/HIV. The overall SVR12 of the 230 patients was 99.57%，the SVR12 of the GT3a type patients was 100.00%，the GT3b type patients 98.92%. The SVR12 of the patients with CHC，CC and DCC were 99.45%，100.00% and 100.00%，respectively. The SVR12 of the patients with single HCV infection，HCV/HIV infection，HBV/HCV infection and HBV/HCV/HIV were 99.47%，100.00%，100.00% and 100.00%，respectively. No patient quit the direct-acting antivirals (DAAs) treatment due to the drug-induced adverse reactions. 1 patient had relapse due to irregular administration of DAAs.CONCLUSION The virological response rate is high among the patients with GT3 CHC and liver cirrhosis who are treated with single SOF/VEL or the combination with RBV，with the safety favorable.
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