索非布韦联合雷迪帕韦治疗慢性丙型肝炎患者疗效研究*

doi:10.3969/j.issn.1672-5069.2022.01.007

摘要/Abstract

摘要： 目的探讨应用索非布韦(SOF)联合雷迪帕韦(LDV)治疗慢性丙型肝炎(CHC)患者的疗效。方法 2017年8月～2020年8月我院诊治的CHC患者116例,给予SOF联合LDV治疗3个月。计算肝纤维化四指数(FIB-4),采用RT-PCR法检测HCV RNA,采用单因素和多因素Logistic回归分析影响CHC患者获得持续病毒学应答(SVR)的影响因素,应用受试者工作曲线(ROC)分析指标的预测效能。结果在治疗结束后随访6个月,116例CHC患者血清ALT、AST和外周血PLT计数分别为(32.4±6.8)U/L、(36.5±9.2)U/L和(224.6±31.9)×10⁹/L,显著低于治疗结束时【分别为(56.6±11.7)U/L、(64.7±11.8)U/L和(262.3±41.7)×10⁹/L,P＜0.05】或治疗前【分别为(204.3±41.6)U/L、(131.2±26.5)U/L和(313.7±53.6)×10⁹/L,P＜0.05】;FIB-4和HCV RNA水平分别为(0.9±0.1)和(1.1±1.2)lgU/mL,显著低于治疗结束时【分别为(1.2±0.2)和(1.9±1.1)lgU/mL,P＜0.05】或治疗前【分别为(1.4±0.2)和(6.4±1.3)lgU/mL,P＜0.05】;本组CHC患者获得快速病毒学应答率(RVR)为75.0%,治疗结束时病毒学应答率(ETVR)为89.7%,SVR为82.0%;多因素Logistic回归分析显示,FIB-4和血清HCV RNA是影响CHC患者获得SVR的独立影响因素(P＜0.05);联合治疗前FIB-4＜1.65和血清HCV RNA载量为(6.6±0.8)lgU/mL为截断点,其预测CHC患者在治疗后获得SVR的AUC为0.875,敏感性为83.2%,特异性为90.5%。结论 SOF联合LDV治疗CHC患者可获得很好的治疗效果,FIB-4水平低和血清HCV RNA载量低的患者可能获得更好的抗病毒效果。

关键词: 慢性丙型肝炎, 索非布韦, 雷迪帕韦, 肝纤维化四指数, 治疗

Abstract: Objective The purpose of this study was to investigate the efficacy of sofosbuvir (SOF) and ledipasvir (LDV) in patients with chronic hepatitis C (CHC). Methods 116 patients with CHC were recruited in our hospital, and all were treated with SOF and LDV without ribavirin for three months. The four indexes of liver fibrosis (FIB-4) was calculated and serum HCV RNA loads were detected by RT-PCR. The univariate and multivariate Logistic regression analyses were applied to screenthe independent impacting factors for sustained virological response (SVR) the patients got after antiviral treatment. The receiver operating characteristic (ROC) curve was applied to analyze the predictive efficacy of parameters for SVR. Results At the end of six month followed-up after the discontinuation of the regimen, serum ALT, AST levels and platelet counts in 116 patients with CHC were (32.4±6.8)U/L,(36.5±9.2)U/L and (224.6±31.9)×10⁹/L, all significantly lower than [(56.6±11.7)U/L, (64.7±11.8)U/L and (262.3±41.7)×10⁹/L, respectively, P＜0.05] at the end of treatment or [(204.3±41.6)U/L, (131.2±26.5)U/L and (313.7±53.6)×10⁹/L, respectively, P＜0.05] before treatment; the FIB-4 and serum HCV RNA load were (0.9±0.1) and (1.1±1.2)lgU/mL, both significantly lower than [(1.2±0.2) and (1.9±1.1)lgU/mL, respectively, P＜0.05] at the end of the treatment or [(1.4±0.2) and (6.4±1.3)lgU/mL, respectively, P＜0.05] before treatment; the rapid virologic response, the end of treatment virologic response and SVR in our series were 75.0%, 89.7% and 82.0%; the multivariate Logistic regression analysis showed that the FIB-4 and serum HCV RNA loads were the impacting factors for SVR (P＜0.05); the AUC was 0.875 with the sensitivity of 83.2% and the specificity of 90.5% when the combination of FIB-4＜1.65 and serum HCV RNA load equal to (6.6±0.8)lgU/mL before treatment were set as the cut-off-value. Conclusion The combination of SOF and LDV in treating patients with CHC is efficacious, and the patients at presentation with low FIB-4 and serum HCV RNA might obtain a better efficacy.

Key words: Hepatitis C, Sofosbuvir, Ledipasvir, Four indexes of liver fibrosis, Therapy

郑淑颖, 郭欢欢, 程长浩, 冯珍珍. 索非布韦联合雷迪帕韦治疗慢性丙型肝炎患者疗效研究^*[J]. 实用肝脏病杂志, 2022, 25(1): 26-29.

Zheng Shuying, Guo Huanhuan, Cheng Changhao, et al. Treatment with sofosbuvir and ledipasvir for three months without ribavirin in patients with chronic hepatitis C[J]. Journal of Practical Hepatology, 2022, 25(1): 26-29.

参考文献

[1] 李剑萍,陈学福,严勤,等.索磷布韦维帕他韦联合或不联合利巴韦林治疗中国成人慢性丙型肝炎病毒感染者的疗效和安全性.中华肝脏病杂志,2020,28(10):831-837.
[2] Kandeel A, Genedy M, El-Refai S, et al. The prevalence of hepatitis Cvirus infection in Egypt 2015: implications for future policy onprevention and treatment. Liver Int, 2017, 37(1):45-53.
[3] 曾庆磊,吕君,付艳玲,等.慢性丙型肝炎经抗病毒治疗后获得持续病毒学应答患者发生肝细胞癌危险因素预测分析.中华传染病杂志,2016,34(3):160-165.
[4] 向光明,黄孝伦,姚豫桐,等.慢性丙型肝炎相关性肝细胞癌患者根治性外科干预后使用干扰素的Meta分析.中华肝胆外科杂志,2016,22(12):805-809.
[5] Toshikuni N. Therapy with direct-acting antiviral agents for hepatitis C-related liver cirrhosis. Gut Liver, 2017, 11(3):335-348.
[6] Kaku A. FIB-4 stage of liver fibrosis predicts incident heart failureamong HIV-infected and uninfected patients. Hepatology, 2017, 66(4):1286-1295.
[7] 中华医学会肝病学分会和感染病学分会.《丙型肝炎防治指南》2019年更新版.实用肝脏病杂志,2020,23(1):S33-52.
[8] Eldesoky E S,Abdelhafez A T,Cusato J,et al. The role of itpa and ribavirin transporter genes polymorphisms in prediction of ribavirin-induced anaemia in chronic hepatitis C Egyptian patients. Clin Exp Pharmacol Physiol, 2017, 44(9 ):965-968.
[9] Roncero C, Littlewood R, Vega P, et al. Chronic hepatitis C and individuals with a history of injecting drugs in Spain: population assessment,challenges for successful treatment. Eur J Gastroenterol Hepatol, 2017, 29(6): 629-633.
[10] Hung H C,Liao H H,ChenSC,et al. Maintenance interferon therapy in chronic hepatitis C patients who failed initial antiviral therapy: a meta-analysis. Medicine (Baltimore ), 2019, 98(19):15563-15564.
[11] Wang S, Qin E, Zhi Y, et al. Severe autoimmune hemolytic anemia during pegylated interferon plus ribavirin treatment for chronic hepatitis C: a case report. Clin Case Rep, 2017, 5(9): 1490-1492.
[12] Tabernilla A, Grandal M, Pernas B, et al.Viral dynamics among hepatitis C virus chronic infected patients during direct-acting antiviral agents therapy: impact for monitoring and optimizing treatment duration. Eur J Gastroenterol Hepatol, 2017, 29(7):781-785.
[13] El-Khayat H, Fouad Y, Mohamed HI, et al. Sofosbuvir plus daclatasvir with or without ribavirin in 551 patients with hepatitis C-related cirrhosis, genotype 4. Aliment Pharmacol Ther, 2018, 47(5):674-679.
[14] Boglione L,Pinna SM,Cardellino CS, et al. Treatment with daclatasvir and sofosbuvir for 24 weeks without ribavirin in cirrhotic patients who failed first-generation prolease inhibitors. Infection, 2017, 45(1):103-106.
[15] Tseng T C,Liu CJ,Su T H,et al. Fibrosis-4 index predicts cirrhosis risk and liver-related mortality in 2075 patients with chronic HBV infection. Aliment Pharmacol Ther, 2018, 47(11 ):1480-1489.
[16] Wang W,Zhao X, Li G, et al. Diagnostic thresholds and performance of noninvasive fibrosis scores are limited by age in patients with chronic hepatitis B. J Med Virol, 2019, 91(7):1279-1287.
[17] Butt A A, Ren Y, Re V L,et al. Comparing Child-Pugh, MELD and FIB-4 to predict clinical outcomes in CHC-infected persons: Results from ERCHIVES. Clin Infect Dis, 2017, 65(1):64-72.
[18] Boglione L, Mornese PS, De NA, et al. Treatment with direct-acting antiviral agents of hepatitis C virus infection in injecting drug users:aprospective study. J Viral Hepat, 2017, 24(10):850-785.

索非布韦联合雷迪帕韦治疗慢性丙型肝炎患者疗效研究^*

Treatment with sofosbuvir and ledipasvir for three months without ribavirin in patients with chronic hepatitis C

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

本文评价

[1]	孙皆齐, 姜绍文, 汪铮. 应用艾尔巴韦/格拉瑞韦治疗基因1b型慢性丙型肝炎初治和经治患者效果对比研究^*[J]. 实用肝脏病杂志, 2022, 25(2): 195-198.
[2]	马国斌, 赵晓宏, 赵鹏, 杨冰. 自身免疫性肝炎患者肝组织IL-35表达和外周血髓样抑制细胞百分比变化临床意义探讨^*[J]. 实用肝脏病杂志, 2022, 25(2): 199-202.
[3]	曾议, 李国, 李红翠, 彭雅松, 田峰, 王小军. 熊去氧胆酸治疗原发性胆汁性胆管炎患者疗效及对血清Nrf2和HO-1水平的影响[J]. 实用肝脏病杂志, 2022, 25(2): 211-214.
[4]	陈凯, 居峰. 多烯磷脂酰胆碱联合扶正化瘀片治疗非酒精性脂肪性肝病患者肝脏超声脂肪变性评分变化^*[J]. 实用肝脏病杂志, 2022, 25(2): 219-222.
[5]	王本贤, 李伟, 李东生, 李华. 腹水浓缩回输联合抗感染治疗失代偿期乙型肝炎肝硬化患者疗效研究^*[J]. 实用肝脏病杂志, 2022, 25(2): 247-250.
[6]	刘松涛, 刘梅, 渠亚超, 李瑞利, 邵晨, 闾军. 4例原发性肝脏神经内分泌肿瘤临床分析及文献复习[J]. 实用肝脏病杂志, 2022, 25(2): 251-254.
[7]	王婵, 沈长清, 吴晓琼, 邓程伟, 谢文蕊. 表柔比星药物洗脱微球肝动脉化疗栓塞术治疗不可手术切除的原发性肝癌患者临床疗效和安全性分析[J]. 实用肝脏病杂志, 2022, 25(2): 259-262.
[8]	周建, 陆旭, 朱岩举, 王庆元, 冯明明, 郭胜利. 腹腔镜与开腹肝切除术治疗肝内胆管细胞癌患者疗效与安全性研究[J]. 实用肝脏病杂志, 2022, 25(2): 275-278.
[9]	刘海生, 宁纯民, 孙文兵. 血管瘤剥脱术和肝切除术治疗肝血管瘤患者疗效研究^*[J]. 实用肝脏病杂志, 2022, 25(2): 279-282.
[10]	王思琪, 申远, 崔振兴, 李岩. 腹腔镜穿刺置管引流术与腹腔镜切开置管引流术治疗肝脓肿患者疗效观察[J]. 实用肝脏病杂志, 2022, 25(2): 283-286.
[11]	何翼彪, 王智鹏, 白磊. 三维可视化系统联合纤维胆道镜治疗肝胆管结石患者近期疗效研究^*[J]. 实用肝脏病杂志, 2022, 25(2): 287-290.
[12]	田婉婷, 陈保银, 马竹芳, 徐菁, 马臻奇. 改良鼻胆管与普通鼻胆管引流在经胆囊入路治疗细径胆总管结石患者疗效研究^*[J]. 实用肝脏病杂志, 2022, 25(2): 291-294.
[13]	尹天泉, 赵程, 刘岩. 参附注射液治疗脓毒症并发急性肝损伤患者疗效研究[J]. 实用肝脏病杂志, 2022, 25(2): 295-296.
[14]	包飞云, 李彤, 王玉珊, 张亚萍, 李娟, 麻爱娣, 刘元元, 张岭漪. 索磷布韦维帕他韦治疗慢性丙型肝炎患者疗效和安全性观察:一项单中心真实世界回顾性分析[J]. 实用肝脏病杂志, 2022, 25(1): 30-33.
[15]	吕春卉, 李大炜, 王小洁, 康晓平, 韩宗晟, 朱允. 二甲双胍联合辛伐他汀治疗非酒精性脂肪性肝病合并2型糖尿病患者疗效研究[J]. 实用肝脏病杂志, 2022, 25(1): 50-53.