2. Academic Validation
  3. Efficacy and Safety of All-oral Emitasvir and Sofosbuvir in Patients with Genotype 1b HCV Infections without Cirrhosis

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

  • J Clin Transl Hepatol. 2020 Sep 28;8(3):255-261. doi: 10.14218/JCTH.2020.00031.
Huiying Rao 1,  Xingxiang Yang 2,  Youwen Tan 3,  Qin Ning 4,  Daokun Yang 5,  Jiefei Wang 6,  Yongfeng Yang 7,  Sujun Zheng 8,  Dongliang Yang 9,  Jinlin Hou 10,  Qing Xie 11,  Caiyan Zhao 12,  Lunli Zhang 13,  Xiaorong Mao 14,  Tong Sun 15,  Lang Bai 16,  Fuchun Zhang 17,  Jinglan Jin 18,  Yingren Zhao 19,  Maorong Wang 20,  Wen Xie 21,  Yingjie Ma 22,  Jun Quan 23,  Xuebing Yan 24,  Ping An 25,  Feng Lin 26,  Jidong Jia 27,  Xiaoxuan Hu 28,  Zuojiong Gong 29,  Jie Wu 30,  Yongping Chen 31,  Zhansheng Jia 32,  Minghua Lin 33,  Guiqiang Wang 34,  Yueyong Zhu 35,  Yingjun Zhang 36,  Hongming Xie 36,  Lin Luo 36,  Qingyun Ren 36,  Rui Huang 1,  Lai Wei 37
Affiliations

Affiliations

  • 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.
PMID: 33083247 DOI: 10.14218/JCTH.2020.00031
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

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

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