Objective: To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection. Methods: Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval. Results: 132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death. Conclusion: Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.
目的： 评估索磷布韦（南京正大天晴制药有限公司）联合利巴韦林治疗基因2型慢性丙型肝炎病毒感染的受试者的有效性和安全性。 方法： 在全国16家研究中心筛选初治或经治的基因2型慢性丙型肝炎病毒感染者，所有受试者接受每日一次的索磷布韦（400 mg）联合利巴韦林（体质量< 75 kg，1 000 mg/d，早上400 mg，晚上600 mg；体质量≥75 kg，1 200 mg/d，早晚各600 mg）治疗12周，停药后随访12周。连续变量采用均值±标准差表示，不同随访时间点病毒学应答的受试者比例及95%置信区间采用极大似然比点估计及Clopper-Pearson区间估计。 结果： 全国16家研究中心共入组132例基因2型慢性丙型肝炎病毒感染的受试者，其中12例受试者伴有肝硬化，其余120例受试者不伴有肝硬化。131例受试者完成了本研究，1例受试者在完成停药后第4周访视后失访。停药12周获得的持续病毒学应答率为96.2%（95%可信区间：92.37%～99.16%）。4例受试者发生病毒学复发。入组的132例受试者中，119例（90.2%）受试者共报告了617例次治疗期不良事件（TEAE），其中与索磷布韦和/或利巴韦林相关TEAE 359例次（76.5%）。其中3级及3级以上TEAE 9例次，共有6例（4.5%）受试者发生了6例次严重不良事件，仅1例严重不良事件与索磷布韦和利巴韦林相关（不稳定型心绞痛）。无导致停药的不良事件。无导致死亡的不良事件。 结论： 索磷布韦联合利巴韦林治疗基因2型慢性丙型肝炎病毒感染具有较高的SVR率，发生的不良反应大多为轻度，安全性可接受。.
Keywords: Direct-acting antiviral agents; Genotype 2; Hepatitis C; Ribavirin; Sofosbuvir; Sustained virological response.