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Zhonghua Gan Zang Bing Za Zhi. 2018 May 20;26(5):353-358. doi: 10.3760/cma.j.issn.1007-3418.2018.05.008.

[Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin in Asian adult patients with chronic HCV genotype 1b infection and compensated cirrhosis].

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

Author information

1
Peking University People's Hospital, Beijing 100044, China.
2
Peking University First Hospital, Beijing 100034, China.
3
AbbVie Inc., North Chicago 60064, IL, USA.
4
Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
5
Rui Jin Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai 200025, China.
6
81 Hospital, The Chinese People's Liberation Army, Nanjing 210002, China.
7
The 8th Hospital of Guangzhou, Guangzhou 510000, China.
8
Beijing You'an Hospital, Capital Medical University, Beijing 100069, China.
9
Nan Fang Hospital, Guangzhou 510515, China.
10
Shengyang 6th People's Hospital, Shenyang 110006, China.
11
The 1st Hospital of Xinjiang Medical University, Urumqi 830011, China.
12
West China School of Medicine, Chengdu 610041, China.
13
Nanjing 2nd Hospital, Nanjing 210028, China.
14
The 1st Hospital of Xi'an Jiaotong University, Xi'an 710065, China.
15
Tangdu Hospital, Xi'an 710038, China.
16
The 1st Hospital of Jilin University, Changchun 130021, China.
17
The 3rd Hospital, Sun Yay-sen Hospital, Guangzhou 510630, China.
18
The 1st Hospital of Lanzhou University, Lanzhou 730000, China.
19
The Infectious Hospital of Fuzhou, Fuzhou 350001, China.
20
Xijing Hospital of The 4th Military Medical University, Xi'an 710032, China.
21
AbbVie. Shanghai 200041, China.
22
Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.

Abstract

in English, Chinese

Objective: To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis. Methods: An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs. Results: A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal. Conclusion: Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.

KEYWORDS:

Direct-acting antiviral agents; Hepatitis C virus; Liver cirrhosis

[Indexed for MEDLINE]

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