A phase II, single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of sofosbuvir combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection
- VernacularTitle: 一项评估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受试者的有效性和安全性的单臂、开放、多中心Ⅱ期临床研究
- Author:
Yinghui GAO
1
;
Guangming LI
2
;
Qinglong JIN
3
;
Yingren ZHAO
4
;
Zhansheng JIA
5
;
Xiaorong MAO
6
;
Yongfeng YANG
7
;
Jia SHANG
8
;
Gongchen WANG
9
;
Wen XIE
10
;
Shanming WU
11
;
Mingxiang ZHANG
12
;
Jinlin HOU
13
;
Dongliang LI
14
;
Yuemin NAN
15
;
Yujuan GUAN
16
;
Chunxia ZHU
17
;
Yangzhou YUAN
17
;
Lai WEI
18
Author Information
- Publication Type:Journal Article
- Keywords: Hepatitis C; Genotype 2; Direct-acting antiviral agents; Sofosbuvir; Ribavirin; Sustained virological response
- From: Chinese Journal of Hepatology 2019;27(5):352-357
- CountryChina
- Language:Chinese
-
Abstract:
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.