sofosbuvir/ledipasvir方案治疗HCV 6a型慢性丙型肝炎的临床效果和安全性

李威; 康谊; 丁岗强; 尚佳; 周元平

doi:10.3969/j.issn.1001-5256.2019.03.015

sofosbuvir/ledipasvir方案治疗HCV 6a型慢性丙型肝炎的临床效果和安全性

DOI: 10.3969/j.issn.1001-5256.2019.03.015

1. 河南省人民医院感染科
2. 南方医科大学南方医院感染内科

基金项目:

国家自然科学基金资助项目(81470856)；河南省科技攻关计划项目(162102310030)；

详细信息

中图分类号: R512.63
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出版历程
- 收稿日期: 2018-11-30
- 出版日期: 2019-03-20

Clinical effect and safety of sofosbuvir-ledipasvir regimen in treatment of patients with HCV genotype 6a chronic hepatitis C

Department of Infectious Diseases, Henan Provincial People's Hospital

Research funding:

摘要

摘要: 目的探讨sofosbuvir/ledipasvir（SOF+LDV）治疗HCV 6a型慢性丙型肝炎的效果和安全性。方法本研究为前瞻性观察研究,纳入2014年10月到2016年12月在河南省人民医院及南方医院感染科就诊的63例HCV 6a型慢性丙型肝炎患者。将所纳入患者分为2组,分别给予SOF+LDV 12周、PEG-IFN联合利巴韦林（PR） 24周抗病毒治疗。在治疗期间及治疗终止后随访检测HCV RNA,评价病毒学应答。计数资料2组间比较采用χ2检验;计量资料2组间比较采用Mann-Whitney U检验。结果 PR组和SOF+LDV组患者的快速病毒学应答率（85. 3%vs 100%）、治疗结束时病毒学应答率（94. 1%vs 100%）差异均无统计学意义（P值均> 0. 05）。SOF+LDV组持续病毒学应答率为96. 4%,显著高于PR组的73. 5%（χ2=4. 38,P=0. 036）。PR组总体不良反应发生率明显高于SOF+LDV组（χ2=7. 54,P=0. 006）。SOF+LDV组后续随访有1例肝硬化患者发生小肝癌。而PR组至随访截止时间无1例患者发生肝癌。结...
- 肝炎,丙型,慢性 /
- 基因型 /
- 持续病毒学应答 /
- 治疗结果
Abstract: Objective To investigate the clinical effect and safety of sofosbuvir ( SOF) -ledipasvir ( LDV) in the treatment of patients withHCV genotype 6 a chronic hepatitis C ( CHC) . Methods A total of 63 patients with HCV genotype 6 a CHC who visited Department of In-fectious Diseases, Henan Provincial People's Hospital and Nanfang Hospital, from October 2014 to December 2016 were enrolled in thisprospective observational study. They were divided into SOF-LDV group ( treated with SOF-LDV for 12 weeks) and PR group ( treatedwith pegylated interferon combined with ribavirin for 24 weeks) . HCV RNA was measured during treatment and follow-up, and virologicresponse was evaluated. The chi-square test was used for comparison of categorical data between two groups, and the Mann-Whitney Utest was used for comparison of continuous data between two groups. Results There were no significant differences between the PR groupand the SOF-LDV group in rapid virologic response rate ( 85. 3% vs 100%, P > 0. 05) and virologic response rate at the end of treatment ( 94. 1% vs 100%, P > 0. 05) . The SOF-LDV group had a significantly higher sustained virologic response rate than the PR group ( 96.4% vs 73. 5%, χ2= 4. 38, P = 0. 036) . The PR group had a significantly higher incidence rate of adverse events than the SOF-LDV group ( χ2= 7. 54, P = 0. 006) . During follow-up, one patient with liver cirrhosis in the SOF-LDV group developed small hepatocellular carcino-ma, while no patient in the PR group developed liver cancer at the end of follow-up. Conclusion SOF-LDV for 12 weeks is safe and ef-fective in the treatment of HCV genotype 6 a CHC, but liver cancer should be closely monitored in patients with liver cirrhosis.
- hepatitis C, chronic /
- genotype /
- sustained virological response /
- treatment outcome

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