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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
Clinical efficacy and safety of sofosbuvir tablets combined with ribavirin in treatment of treatment-nave patients with genotype 2 chronic hepatitis C virus infection
文章发布日期:2019年12月20日  来源:  作者:宋广军,饶慧瑛,李广明,等  点击次数:95次  下载次数:13次

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【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调药或暂停用药的不良事件,6(4.4%)例受试者发生了7例次严重不良事件,仅1例考虑与研究用药可能有关(肝低回声区性质待查),未出现导致试验中止或受试者死亡的不良事件。结论 索磷布韦联合利巴韦林治疗初治的基因2型慢性HCV感染可获得较高的持续病毒学应答,不良反应大多为轻度,安全性可接受。
【Abstract】:Objective To investigate the clinical efficacy and safety of sofosbuvir combined with ribavirin in the treatment of treatment-nave patients with genotype 2 chronic hepatitis C virus (HCV) infection. Methods Treatment-nave 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) rate was 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-nave patients with genotype 2 chronic HCV infection, with mild adverse reactions and acceptable safety profile.
【关键字】:丙型肝炎; 基因型; 抗病毒药; 持续病毒学应答
【Key words】:hepatitis C; genotype; antiviral agents; sustained virologic response
【引证本文】:SONG GJ, RAO HY, LI GM, et al. Clinical efficacy and safety of sofosbuvir tablets combined with ribavirin in treatment of treatment-nave patients with genotype 2 chronic hepatitis C virus infection[J]. J Clin Hepatol, 2020, 36(1): 80-83. (in Chinese)
宋广军, 饶慧瑛, 李广明, 等. 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[J]. 临床肝胆病杂志, 2020, 36(1):80-83.

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