索磷布韦联合利巴韦林治疗初治基因2型慢性HCV感染者的有效性及安全性分析

宋广军; 饶慧瑛; 李广明; 郭晓林; 贾战生; 张明香; 贾继东; 姜相君; 郑素军; 赵英仁; 尚佳; 杨兴祥; 蔡大川; 南月敏; 王福生; 毛青; 谢尧; 秦宏; 魏来

doi:10.3969/j.issn.1001-5256.2020.01.018

索磷布韦联合利巴韦林治疗初治基因2型慢性HCV感染者的有效性及安全性分析

DOI: 10.3969/j.issn.1001-5256.2020.01.018

1. 北京大学人民医院肝病科
2. 郑州市第六人民医院肝病科
3. 吉林大学第一医院肝胆胰内科
4. 空军军医大学唐都医院传染病肝病中心
5. 沈阳市第六人民医院中西医结合肝病科
6. 首都医科大学附属北京友谊医院肝病中心
7. 青岛市市立医院消化内科
8. 首都医科大学附属北京佑安医院人工肝中心
9. 西安交通大学医学院第一附属医院感染性疾病科
10. 河南省人民医院感染科
11. 四川省人民医院感染科
12. 重庆医科大学附属第二医院感染科
13. 河北医科大学第三医院中西医结合肝病科
14. 解放军总医院第五医学中心肝病生物研究中心
15. 陆军军医大学第一附属医院感染科
16. 首都医科大学附属北京地坛医院肝病科
17. 北京凯因科技股份有限公司
18. 北京清华长庚医院

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出版历程
- 收稿日期: 2019-08-07
- 出版日期: 2020-01-20

Clinical efficacy and safety of sofosbuvir tablets combined with ribavirin in treatment of treatment-nave patients with genotype 2 chronic hepatitis C virus infection

Department of Hepatology,People's Hospital,Peking University

摘要

摘要: 目的评价索磷布韦联合利巴韦林对初治基因2型慢性HCV感染者的有效性和安全性。方法在全国16家研究中心筛选初治基因2型慢性HCV感染者,所有受试者接受索磷布韦(400 mg/片,1片/d)联合利巴韦林(体质量<75 kg,1000 mg/d;体质量≥75 kg,1200 mg/d)治疗12周,停药随访12周。主要的疗效指标为治疗结束停药随访12周时获得持续病毒学应答情况。次要疗效指标包括:治疗2、4、8、12周及停药后4周时HCV RNA低于定量下限的比率;治疗4、8、12周时病毒学反跳率;停药随访4、12周的复发率。并观察治疗期不良事件发生情况,以评价药物的安全性。结果共入组136例受试者,非肝硬化121例,代偿期肝硬化15例。停药12周获得的持续病毒学应答率为92. 6%(95%可信区间:88. 3%～97. 0%);治疗第8周,有1例病毒学反跳;停药4周时,有8例病毒学复发;停药12周时,有10例病毒学复发。入组的136例受试者中,共有128(94. 1%)例报告了549例次治疗期不良事件,研究用药相关治疗期不良事件243例次(99例受试者,72. 8%),未出现导致索磷布韦...
- 丙型肝炎 /
- 基因型 /
- 抗病毒药 /
- 持续病毒学应答
Abstract: Objective To investigate the clinical efficacy and safety of sofosbuvir combined with ribavirin in the treatment of treatment-naive patients with genotype 2 chronic hepatitis C virus(HCV) infection. Methods Treatment-naive patients with genotype 2 HCV infection were screened in sixteen research centers of China. All patients received sofosbuvir(400 mg/tablet,1 tablet/d) combined with ribavirin(1000 mg/d for patients with a body weight of < 75 kg and 1200 mg/d for those with a body weight of ≥75 kg) for 12 weeks and were followed up for 12 weeks after drug withdrawal. The primary outcome measure was sustained virologic response at week 12 of follow-up,and the secondary outcome measures included the proportion of patients with HCV RNA below the lower limit of quantitation at weeks 2,4,8,and 12 of treatment and after 4 weeks of drug withdrawal,virological rebound rate at weeks 4,8,and 12 of treatment,and recurrence rate at weeks 4 and 12 of follow-up. Adverse events were observed during treatment to evaluate drug safety. Results A total of 136 subjects were enrolled,among whom 121 had no liver cirrhosis and 15 had compensated liver cirrhosis. The sustained virologic response(SVR) ratewas 92. 6%(95% confidence interval: 88. 3%-97. 0%) after 12 weeks of drug withdrawal. At week 8 of treatment,1 patient experienced virological rebound; after 4 weeks of drug withdrawal,8 patients experienced virological rebound; after 12 weeks of drug withdrawal,10 patients experienced virological rebound. Among the 136 subjects,128(94. 1%) reported 549 cases of treatment-emergent adverse events,among which 243 cases were associated with sofosbuvir and/or ribavirin and were reported in 99 subjects(72. 8%). No adverse events leading to the adjustment or discontinuation of sofosbuvir were observed. A total of 7 serious adverse events were reported in 6 patients(4. 4%),among which only one(a low echo area in the liver with unknown nature) was considered possibly associated with sofosbuvir and/or ribavirin. No adverse events leading to study discontinuation or death were observed. Conclusion Sofosbuvir combined with ribavirin can achieve a high SVR rate in treatment-na6 ve patients with genotype 2 chronic HCV infection,with mild adverse reactions and acceptable safety profile.
- hepatitis C /
- genotype /
- antiviral agents /
- sustained virologic response

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参考文献(10)

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