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Zhonghua Gan Zang Bing Za Zhi. 2018 May 20;26(5):359-364. doi: 10.3760/cma.j.issn.1007-3418.2018.05.009.

[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].

[Article in Chinese; Abstract available in Chinese from the publisher]

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.

Abstract

in English, Chinese

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.

KEYWORDS:

Direct-acting antiviral agent; Hepatitis C, chronic; Safety

[Indexed for MEDLINE]

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