Journal of Clinical and Translational Hepatology

Journal of Clinical and Translational Hepatology

Saturday, 10 / 24 / 2020

Articles

ORIGINAL ARTICLE

Efficacy and Safety of All-oral Emitasvir and Sofosbuvir in Patients with Genotype 1b HCV Infections without Cirrhosis

Huiying Rao1, Xingxiang Yang2, Youwen Tan3, Qin Ning4, Daokun Yang5, Jiefei Wang6, Yongfeng Yang7, Sujun Zheng8, Dongliang Yang9, Jinlin Hou10, Qing Xie3Lei Zhang11, Caiyan Zhao12Lunli Zhang13 , Xiaorong Mao14, Tong Sun15, Lang Bai16, Fuchun Zhang17, Jinglan Jin18, Yingren Zhao19, Maorong Wang20, Wen Xie21, Yingjie Ma22, Jun Quan23, Xuebing Yan24, Ping An25, Feng Lin 26, Jidong Jia27Feng Lin 26, Xiaoxuan Hu28, Zuojiong Gong29, Jie Wu30, Yongping Chen31, Zhansheng Jia32, Minghua Lin33, Guiqiang Wang34, Yueyong Zhu35, Yingjun Zhang*,36, Hongming Xie36, Lin Luo36Qingyun Ren36, Rui Huang1and Lai Wei*,1

1  Peking University People’s Hospital, Peking University Hepatology Institute, National Clinical Research Center for Infectious Disease, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing International Cooperation Base for Science and Technology on NAFLD Diagnosis, Beijing, China
2  Department of Infectious Diseases, Sichuan Provincial People’s Hospital, Chengdu, Sichuan, China
3  Department of Hepatology, The Third People’s Hospital of Zhenjiang, Zhenjiang, Jiangsu, China
4  Department of Infectious Diseases, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
5  Department of Infectious Diseases, The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan, China
6  Shanghai Public Health Clinical Center, Shanghai, China
7  Department of Hepatology, The Second Hospital of Nanjing, Nanjing, Jiangsu, China
8  Center of Artificial liver, Beijing Youan Hospital, Capital Medical University, Beijing, China
9  Department of Infectious Disease, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
10  Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
11  Department of Infectious Diseases, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
12  Department of Infectious Diseases, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
13  Department of Infectious Diseases, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
14  Department of Infectious Diseases, The First Hospital of Lanzhou University, Lanzhou, Gansu, China
15  Department of Infectious Diseases, Wuxi Fifth People’s Hospital, Wuxi, Jiangsu, China
16  Infectious Diseases Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China
17  Department of Hepatology, Guangzhou Eighth People’s Hospital, Guangzhou, Guangdong, China
18  Department of Hepato-Biliary-Pancreatic Diseases, The First Hospital of Jilin University, Changchun, Jilin, China
19  Department of Infectious Diseases, Xi’an Jiaotong University First Affiliated Hospital, Xi’an, Shaanxi, China
20  Department of Infectious Diseases, DiBaYi Hospital of the Chinese People’s Liberation Army, Nanjing, Jiangsu, China
21  Hepatology Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China
22  Department of Infectious Diseases, Zhengzhou People’s Hospital, Zhengzhou, Henan, China
23  Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, Hunan, China
24  Department of Infectious Diseases, Xuzhou Medical College Affiliated Hospital, Xuzhou, Jiangsu, China
25  Department of Infectious Diseases, Shenyang Sixth People’s Hospital, Shenyang, Liaoning, China
26  Department of Infectious Diseases, Hainan General Hospital, Haikou, Hainan, China
27  Hepatology Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China
28  Department of Infectious Diseases, Hunan Provincial People’s Hospital, Changsha, Hunan, China
29  Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hubei, China
30  Department of Infectious Diseases, Wuhan central hospital, Wuhan, Hubei, China
31  Department of Infectious Diseases, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
32  Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University of the People’s Liberation Army, Xi’an, Shaanxi, China
33  Department of Hepatology, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, Fujian, China
34  Department of Infectious Diseases, Peking University First Hospital, Beijing, China
35  Department of Infectious Diseases, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
36  State Key Laboratory of Anti-Infective Drug Development (NO.2015DQ780357), Sunshine Lake Pharma Co., Ltd, Dongguan, Guangdong, China
37  Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China
*Correspondence to: Lai Wei, Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University, No. 168, Litang Road, Changping District, Beijing 102218, China. Tel: +86-10-56118881, Fax: +86-10-56118500, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ; Yingjun Zhang, State Key Laboratory of Anti-Infective Drug Development (NO. 2015DQ780357), Sunshine Lake Pharma Co., Ltd., No. 368, Zhen’an Road, Chang’an Town, Dongguan, Guangdong 523871, China. Tel: +86-769-88615888-2337, Fax: +86-769-85370222-2337, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Journal of Clinical and Translational Hepatology 2020;8(3):255-261 DOI: 10.14218/JCTH.2020.00031
Received: April 13, 2020 Accepted: August 12, 2020 Published online: September 11, 2020

Abstract

Background and Aims: Emitasvir is a new type of hepatitis C virus (HCV) nonstructural protein 5A (NS5A) inhibitor, and the data of phase 2 trial has shown emitasvir-sofosbuvir to have good safety and tolerance. We conducted this phase 3 trial to further verify the efficacy and safety.

Methods: We evaluated the antiviral activity and safety of a 12-week regimen of emitasvir phosphate (100 mg) combined with sofosbuvir (400 mg) once daily in non-cirrhotic patients with genotype 1 HCV infection. The primary endpoint was a sustained virological response at 12 weeks (SVR12) after the end of treatment.

Results: Of the 362 patients enrolled in the trial, 39.8% were male, 99.2% had HCV genotype 1b, 0.8% had genotype 1a and 79.8% were treatment-naïve. The average age was 47.2 years. All patients completed the treatment and follow-up. All 3 patients with genotype 1a achieved SVR. Two genotype 1b treatment-naïve patients experienced virologic relapse. The rate of SVR12 was 99.7% (358/359), and SVR24 was 99.4% (357/359) in genotype 1b. Overall, 36.2% had resistance-associated substitutions (RASs) in NS5A and 98.3% had RASs in NS5B at baseline. The RASs at baseline had no effect on the rates of response. Serious adverse events were reported in 16 patients and were not related to emitasvir-sofosbuvir. Most adverse events did not require therapy.

Conclusions: The 12 weeks of treatment with emitasvir-sofosbuvir was a highly efficient and safe treatment for a wide range of patients with HCV genotype 1b infection without cirrhosis, who had not been treated or who had been treated with interferon-based regimen previously.

Keywords

Hepatitis C virus, Genotype 1, Direct acting antivirals, Emitasvir, Sofosbuvir, Combination treatment

Journal of Clinical and Translational Hepatology 2020 vol. 8, 255-261  [ Html  ] [ PDF Full-text ]

© The Authors 2020. This article is published under the terms of the Creative Commons Attribution-Noncommercial License (CC BY-NC 4.0), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license.

 logo

You are here: Home