Efficacy and safety of paritaprevir/ritonavir/ombitasvir combined with dasabuvir in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection: a randomized, double-blind, placebo-controlled study - China data
10.3760/cma.j.issn.1007-3418.2018.05.009
- VernacularTitle: 在初治和经治丙型肝炎病毒基因1b型慢性感染的非肝硬化亚成年患者中评价奥比帕利联合达塞布韦治疗的有效性和安全性：随机、双盲、安慰剂对照研究
- Author:
Lai WEI
1
;
Jun CHENG
2
;
Yan LUO
3
;
Jun LI
4
;
Zhongping DUAN
5
;
Jinlin HOU
6
;
Jidong JIA
7
;
Mingxiang ZHANG
8
;
Yan HUANG
9
;
Qing XIE
10
;
Guiqiang WANG
11
;
Dongliang YANG
12
;
Wei ZHAO
13
;
Caiyan ZHAO
14
;
Hong TANG
15
;
Shumei LIN
16
;
Guozhong GONG
17
;
Junqi NIU
18
;
Zhiliang GAO
19
;
Kopecky-Bromberg SARAH
3
;
Fredrick LINDA
3
;
Mobashery NILOUFAR
3
;
Ye WANG
20
;
Jiefei WANG
21
Author Information
1. Peking University People's Hospital, Beijing 100044, China
2. Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
3. AbbVie Inc., North Chicago 60064, IL, USA
4. Jiangsu Province Hospital, Nanjing 210029, China
5. Beijing You'an Hospital, Capital Medical University, Beijing 100069, China
6. Nan Fang Hospital, Guangzhou 510515, China
7. Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
8. Shenyang 6th People's Hospital, Shenyang 110006, China
9. Xiangya Hospital Central South University, Changsha 410008, China
10. Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
11. Peking University First Hospital, Beijing 100034, China
12. Union Hospital Tongji Mecical College, Huazhong University of Science and Technology, Wuhan 430022, China
13. Nanjing 2nd Hospital, Nanjing 210028, China
14. The 3rd Hospital of Hebei Medical University, Shijiazhuang 500000, China
15. West China School of Medicine, Chengdu 610041, China
16. The 1st Hospital of Xi'an Jiaotong Univeersity, Xi'an 710065, China
17. The 2nd Hospital of Central South University, Changsha 410011, China
18. The 1st Hospital of Jilin University, Changchun 130021, China
19. The 3rd Hospital, Sun Yay-sen Hospital, Guangzhou 510630, China
20. AbbVie. China. Shanghai 200041, China
21. Shanghai Public Health Clinical Center, Shanghai 201508, China
- Publication Type:Journal Article
- Keywords:
Hepatitis C, chronic;
Direct-acting antiviral agent;
Safety
- From:
Chinese Journal of Hepatology
2018;26(5):359-364
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily combined with dasabuvir 250mg, twice daily in non-cirrhotic Chinese adult patients with newly diagnosed and treated chronic HCV genotype 1b infection.
Methods:A randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial was conducted in mainland China, Korea, and Taiwan.Safety and efficacy of OBV/PTV/r plus DSV administered for 12 weeks were evaluated in a newly diagnosed and treated (interferon alpha /pegylated interferon alpha) and ribavirin non-cirrhotic adults with chronic HCVgenotype 1b infection. Patients randomly received OBV/PTV/r plus DSV for 12 weeks (Group A), or placebo for 12 weeks (Group B) followed by an open-label phase of OBV/PTV/r plus DSV for 12 weeks. Sustained response (SVR12) rate obtained at 12 weeks and (SVR24) 24 weeks after discontinuation of treatment, and the incidence of adverse events and laboratory abnormalities after double-blind and open-label phase treatment were assessed.
Results:A total of 410 cases of Chinese patients were included and randomly assigned to group A and B (with 205 cases in each group) in a 1:1 ratio. The rates of SVR12 and SVR24 were 99% (95% CI: 94.8% - 99.8%) in the newly diagnosed patients in group A (205 patients) and the rates of SVR12 and SVR24 were 100% in treated patients (95% CI: 96.3% - 100%). Different baseline characteristics had no effect on SVR12 and SVR24 rates. Most of the adverse events occurred were mild, asymptomatic, and≥ 3 laboratory abnormalities during treatment were rare, including elevation of alanine aminotransferase (2 cases in double-blind stage A group), aspartate aminotransferase (Double-blind stage A (3 cases) and total bilirubin (1 case in open-label phase B group); however, those mild adverse events could be recovered after drug withdrawal or discontinuation. only1 person discontinued drugs due to adverse events (Group B, open-label phase).
Conclusion:The 12 weeks treatment course of OBV/PTV/r combined with DSV produced 99% ~ 100% rates of SVR12 and SVR24 in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection, and the tolerance and safety were good.
