2. Academic Validation
  3. Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single-arm, open-label, phase 3 trial

Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single-arm, open-label, phase 3 trial

  • Liver Int. 2020 Nov;40(11):2685-2693. doi: 10.1111/liv.14633.
Yanhang Gao 1,  Fei Kong 1,  Guangming Li 2,  Cheng Li 2,  Sujun Zheng 3,  Jianmei Lin 4,  Xiaofeng Wen 5,  Jinghua Hu 6,  Xiaozhong Wang 7,  Xiaofeng Wu 8,  Huichun Xing 9,  Jidong Jia 10,  Zhansheng Jia 11,  Yujuan Guan 12,  Chenghao Li 13,  Guicheng Wu 14,  Zhiliang Gao 15,  Zhuangbo Mou 16,  Qin Ning 17,  Qing Mao 18,  Yongfeng Yang 19,  Jing Ning 20,  Li Li 20,  Hai Pan 20,  Desheng Zhou 20,  Yanhua Ding 21,  Hong Qin 20,  Junqi Niu 1
Affiliations

Affiliations

  • 1 Department of Hepatology, the First Hospital of Jilin University, Changchun, China.
  • 2 Cirrhosis Department, Zhengzhou Sixth Municipal People's Hospital, Zhengzhou, Henan, China.
  • 3 Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing You An Hospital, Capital Medical University, Beijing, China.
  • 4 Department of Infectious Diseases, Sichuan Provincial People's Hospital, Chengdu, Sichuan, China.
  • 5 Department of Hepatology, Liuzhou People's Hospital, Liuzhou, China.
  • 6 Liver Failure Treatment and Research Center, the Fifth Medical Center of PLA General Hospital, Beijing, China.
  • 7 Department of Hepatology, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital, Urumqi, Xinjiang, China.
  • 8 Department of Hepatology, Shenyang Sixth People's Hospital, Shenyang, Liaoning, China.
  • 9 Department of Hepatology Division 3, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
  • 10 Liver Research Center, Beijing Youyi Hospital Affiliated to Capital Medical University, Beijing, China.
  • 11 Department of Infectious Diseases, the Second Affiliated Hospital of People's Liberation Army Air Force Medical University, Xi'an, Shaanxi, China.
  • 12 Department of Hepatology, Guangzhou Eighth People's Hospital, Guangzhou, China.
  • 13 Department of Gastroenterology, Yanbian University Affiliated Hospital, Yanji, Jilin, China.
  • 14 Department of Hepatology, Chongqing University Three Gorges Hospital, Chongqing Three Gorges Central Hospital, Wanzhou, Chongqing, China.
  • 15 Department of Infectious Diseases, the Third Affiliated Hospital of Dr Sun Yat-Sen University, Guangzhou, Guangdong, China.
  • 16 Department of Hepatology, Ji'nan Municipal Hospital of Infectious Diseases, Ji'nan, Shandong, China.
  • 17 Department of Infectious Diseases, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
  • 18 Institute of Infectious Diseases, the First Affiliated Hospital of People's Liberation Army Medical University, Chongqing, China.
  • 19 Department of Hepatology, Nanjing Second Municipal Hospital, Nanjing, China.
  • 20 Research and Development Center, Beijing Kawin Technology Share-Holding Co., Ltd, Beijing, China.
  • 21 The Department of Phase I Clinical Trial, the First Hospital of Jilin University, Changchun, Jilin, China.
PMID: 33047868 DOI: 10.1111/liv.14633
Abstract

Background & aim: An affordable, pangenotypic regimen remains as an unmet medical need for chronic hepatitis C patients in China. This single-arm, open-label, multicenter, phase 3 trial evaluated the efficacy and safety of coblopasvir, a pangenotypic non-structural protein 5A (NS5A) inhibitor, combined with sofosbuvir for treating Chinese patients with chronic hepatitis C virus (HCV) Infection.

Methods: Treatment-naïve and interferon-experienced adult patients, including those with advanced fibrosis (F3) or compensated cirrhosis (F4), were treated with a universal, combinational regimen of coblopasvir 60 mg and sofosbuvir 400 mg, once daily, for 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (SVR12).

Results: Overall, 371 patients (men, 51%; age, 47 ± 11 years; genotype 1a < 1%, 1b 48%, 2a 26%, 3a 6%, 3b 7% and 6 12%) were enrolled from 19 sites. Fifty-one patients (14%) had F3, 39 patients (11%) had F4 and 39 patients (11%) were interferon experienced. The overall SVR12 was 97% (95% CI, [94%, 98%]) for the full analysis set and was equal to or above 90% for all predefined subsets. Ten patients (3%) experienced virological relapse and two patients did not complete follow-up. No adverse events (AEs) occurred at a frequency ≥5%, and the most often reported AEs (≥1%) were neutropenia and fatigue. The majority of AEs were mild to moderate and transient without specific medical intervention.

Conclusions: The universal, pangenotypic combo of coblopasvir plus sofosbuvir is an efficacious and safe treatment for Chinese patients monoinfected with HCV of genotype 1, 2, 3 and 6, including those with compensated cirrhosis.

Lay summary: The regimen of coblopasvir and sofosbuvir is a safe and effective treatment for Chinese patients with genotype 1, 2, 3 and 6 HCV Infection, including those with compensated cirrhosis. Therefore, this regimen would be a novel choice of treatment for this patient population.

Keywords

coblopasvir; pangenotypic regimen; safety; sofosbuvir; sustained virological response.

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