国际医药卫生导报 ›› 2025, Vol. 31 ›› Issue (15): 2544-2548.DOI: 10.3760/cma.j.cn441417-20250319-15016

• 论著 • 上一篇    下一篇

索磷布韦/维帕他韦联合或不联合格卡瑞韦治疗基因3型慢性丙型肝炎患者的疗效

高妮 曹丹 高云飞   

  1. 榆林市第一医院感染疾病科,榆林 719000

  • 收稿日期:2025-03-19 出版日期:2025-08-01 发布日期:2025-08-21
  • 通讯作者: 高云飞,Email:451623746@qq.com
  • 基金资助:

    陕西省重点研发计划(2020SF-064)

Efficacy of sofosbuvir/velpatasvir with or without glecaprevir in the treatment of genotype 3 chronic hepatitis C

Gao NiCao DanGao Yunfei   

  1. Infectious Disease Department, The First Hospital of Yulin, Yulin 719000, China

  • Received:2025-03-19 Online:2025-08-01 Published:2025-08-21
  • Contact: Gao Yunfei, Email: 451623746@qq.com
  • Supported by:

    Shaanxi Province Key Research and Development Program (2020SF-064)

摘要:

目的 评价索磷布韦/维帕他韦(SOF/VEL)联合或不联合格卡瑞韦治疗基因3型慢性丙型肝炎(CHC)患者的疗效。方法 选取2019年6月至2021年12月期间于榆林市第一医院就诊的236例基因3型CHC患者,其中男121例,女115例,年龄(56.93±19.11)岁,CHC患者155例、丙型肝炎代偿期肝硬化(hepatitis C virus compensated cirrhosis,HCV-CLC)患者81例。所有患者应用SOF/VEL(每日一次,每次SOF 400 mg/VEL 100 mg)联合或不联合格卡瑞韦(每日一次,每次100 mg)治疗,连续治疗12周。比较两组患者基线、治疗第4周、治疗第12周以及停药12周后的检查指标变化。采用独立样本t检验、配对t检验、Mann-Whitney U检验、χ2检验进行统计学分析。结果 CHC组治疗第4周、第12周及停药12周后应答率为36.13%(56/155)、87.10%(135/155)、94.84%(147/155),HCV-CLC组为13.58%(11/81)、44.44%(36/81)、67.90%(55/81),差异均有统计学意义(均P<0.05)。CHC组治疗第4周、第12周及停药12周后丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)和碱性磷酸酶(ALP)分别为35(31,55)U/L、57(30,78)U/L、123(109,166)U/L,27(23,50)U/L、37(25,45)U/L、84(50,115)U/L,15(11,33)U/L、18(10,36)U/L、43(45,76)U/L,与基线时[75(40,100)U/L、84(63,111)U/L、196(144,238)U/L]比较,差异均有统计学意义(均P<0.05)。HCV-CLC组治疗第4周、第12周及停药12周后ALT、AST、ALP分别为42(22,50)U/L、56(46,67)U/L、147(120,160)U/L,27(20,41)U/L、33(16,40)U/L、82(70,125)U/L,21(15,23)U/L、18(13,25)U/L、60(44,77)U/L,与基线时[73(42,110)U/L、87(57,106)U/L、196(155,257)U/L]比较,差异均有统计学意义(均P<0.05)。CHC组治疗第4周、第12周和停药12周后肝硬度值为(8.87±1.52)kPa、(5.52±1.72)kPa、(5.10±1.64)kPa,与基线时[12.70±2.94)kPa]比较,差异均有统计学意义(均P<0.05);HCV-CLC组治疗第4周、第12周和停药12周后肝硬度值为(14.62±4.57)kPa、(8.86±2.75)kPa、(5.46±1.81)kPa,与基线时[25.61±6.46)kPa]比较,差异均有统计学意义(均P<0.05)。基线、治疗第4周及治疗第12周CHC组肝硬度值低于HCV-CLC组(均P<0.05),而停药12周后两组肝硬度值差异无统计学意义(P>0.05)。结论 SOF/VEL联合或不联合格卡瑞韦治疗CHC患者有显著疗效。

关键词:

索磷布韦/维帕他韦, 格卡瑞韦, 基因3型慢性丙型肝炎, 肝硬化, 疗效

Abstract:

Objective To evaluate the efficacy of sofosbuvir/velpatasvir (SOF/VEL) with or without glecaprevir in the treatment of genotype 3 chronic hepatitis C (CHC). Methods A total of 236 patients with genotype 3 CHC who were treated at the First Hospital of Yulin from June 2019 to December 2021 were selected, including 121 males and 115 females, with an age of (56.93±19.11) years old, 155 cases of CHC and 81 cases of hepatitis C virus compensated cirrhosis (HCV-CLC). All patients were treated with SOF/VEL (400 mg SOF/100 mg VEL once daily) with or without glecaprevir (100 mg once daily) for 12 consecutive weeks. The changes in the examination indicators were compared between the two groups at baseline, the 4th week of treatment, the 12th week of treatment, and the 12th week after drug withdrawal. Statistical analysis was conducted using independent sample t test, paired t test, Mann-Whitney U test, and χ2 test. Results The response rates of the CHC group at the 4th week of treatment, the 12th week of treatment, and the 12th week after drug withdrawal were 36.13% (56/155), 87.10% (135/155), and 94.84% (147/155), and those of the HCV-CLC group were 13.58% (11/81), 44.44% (36/81), and 67.90% (55/81), with statistically significant differences (all P<0.05). In the CHC group, the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) at the 4th week of treatment, the 12th week of treatment, and the 12th week after drug withdrawal were 35 (31, 55) U/L, 57 (30, 78) U/L, 123 (109, 166) U/L, 27 (23, 50) U/L, 37 (25, 45) U/L, 84 (50, 115) U/L, 15 (11, 33) U/L, 18 (10, 36) U/L, and 43 (45, 76) U/L, and there were statistically significant differences compared with those at baseline [75 (40, 100) U/L, 84 (63, 111) U/L, and 196 (144, 238) U/L] (all P<0.05). In the HCV-CLC group, the levels of ALT, AST, and ALP at the 4th week of treatment, the 12th week of treatment, and the 12th week after drug withdrawal were 42 (22, 50) U/L, 56 (46, 67) U/L, 147 (120, 160) U/L, 27 (20, 41) U/L, 33 (16, 40) U/L, 82 (70, 125) U/L, 21 (15, 23) U/L, 18 (13, 25) U/L, and 60 (44, 77) U/L, and there were statistically significant differences compared with those at baseline [73 (42, 110) U/L, 87 (57, 106) U/L, and 196 (155, 257) U/L] (all P<0.05). The liver stiffness values of the CHC group at the 4th week of treatment, the 12th week of treatment, and the 12th week after drug withdrawal were (8.87±1.52) kPa, (5.52±1.72) kPa, and (5.10±1.64) kPa, and there were statistically significant differences compared with that at baseline [(12.70±2.94) kPa] (all P<0.05). The liver stiffness values of the HCV-CLC group at the 4th week of treatment, the 12th week of treatment, and the 12th week after drug withdrawal were (14.62±4.57) kPa, (8.86±2.75) kPa, and (5.46±1.81) kPa, and there were statistically significant differences compared with that at baseline [(25.61±6.46) kPa] (all P<0.05). The liver stiffness value in the CHC group was lower than that in the HCV-CLC group at baseline, the 4th week of treatment, and the 12th week of treatment (all P<0.05), but there was no statistically significant difference in the liver stiffness value between the two groups at the 12th week after drug withdrawal (P>0.05). Conclusion SOF/VEL with or without glecaprevir has significant efficacy in the treatment of CHC patients.

Key words:

Sofosbuvir/velpatasvir, Glecaprevir, Genotype 3 chronic hepatitis C, Liver cirrhosis, Curative effect