PMID- 33047868 OWN - NLM STAT- MEDLINE DCOM- 20210621 LR - 20210621 IS - 1478-3231 (Electronic) IS - 1478-3223 (Print) IS - 1478-3223 (Linking) VI - 40 IP - 11 DP - 2020 Nov TI - Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single-arm, open-label, phase 3 trial. PG - 2685-2693 LID - 10.1111/liv.14633 [doi] AB - 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-naive 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. CI - (c) 2020 The Authors. Liver International published by John Wiley & Sons Ltd. FAU - Gao, Yanhang AU - Gao Y AD - Department of Hepatology, the First Hospital of Jilin University, Changchun, China. FAU - Kong, Fei AU - Kong F AD - Department of Hepatology, the First Hospital of Jilin University, Changchun, China. FAU - Li, Guangming AU - Li G AD - Cirrhosis Department, Zhengzhou Sixth Municipal People's Hospital, Zhengzhou, Henan, China. FAU - Li, Cheng AU - Li C AD - Cirrhosis Department, Zhengzhou Sixth Municipal People's Hospital, Zhengzhou, Henan, China. FAU - Zheng, Sujun AU - Zheng S AD - Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing You An Hospital, Capital Medical University, Beijing, China. FAU - Lin, Jianmei AU - Lin J AD - Department of Infectious Diseases, Sichuan Provincial People's Hospital, Chengdu, Sichuan, China. FAU - Wen, Xiaofeng AU - Wen X AD - Department of Hepatology, Liuzhou People's Hospital, Liuzhou, China. FAU - Hu, Jinghua AU - Hu J AUID- ORCID: 0000-0002-0647-9898 AD - Liver Failure Treatment and Research Center, the Fifth Medical Center of PLA General Hospital, Beijing, China. FAU - Wang, Xiaozhong AU - Wang X AD - Department of Hepatology, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital, Urumqi, Xinjiang, China. FAU - Wu, Xiaofeng AU - Wu X AD - Department of Hepatology, Shenyang Sixth People's Hospital, Shenyang, Liaoning, China. FAU - Xing, Huichun AU - Xing H AD - Department of Hepatology Division 3, Beijing Ditan Hospital, Capital Medical University, Beijing, China. FAU - Jia, Jidong AU - Jia J AD - Liver Research Center, Beijing Youyi Hospital Affiliated to Capital Medical University, Beijing, China. FAU - Jia, Zhansheng AU - Jia Z AD - Department of Infectious Diseases, the Second Affiliated Hospital of People's Liberation Army Air Force Medical University, Xi'an, Shaanxi, China. FAU - Guan, Yujuan AU - Guan Y AD - Department of Hepatology, Guangzhou Eighth People's Hospital, Guangzhou, China. FAU - Li, Chenghao AU - Li C AD - Department of Gastroenterology, Yanbian University Affiliated Hospital, Yanji, Jilin, China. FAU - Wu, Guicheng AU - Wu G AD - Department of Hepatology, Chongqing University Three Gorges Hospital, Chongqing Three Gorges Central Hospital, Wanzhou, Chongqing, China. FAU - Gao, Zhiliang AU - Gao Z AD - Department of Infectious Diseases, the Third Affiliated Hospital of Dr Sun Yat-Sen University, Guangzhou, Guangdong, China. FAU - Mou, Zhuangbo AU - Mou Z AD - Department of Hepatology, Ji'nan Municipal Hospital of Infectious Diseases, Ji'nan, Shandong, China. FAU - Ning, Qin AU - Ning Q AUID- ORCID: 0000-0002-2027-9593 AD - Department of Infectious Diseases, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China. FAU - Mao, Qing AU - Mao Q AD - Institute of Infectious Diseases, the First Affiliated Hospital of People's Liberation Army Medical University, Chongqing, China. FAU - Yang, Yongfeng AU - Yang Y AD - Department of Hepatology, Nanjing Second Municipal Hospital, Nanjing, China. FAU - Ning, Jing AU - Ning J AD - Research and Development Center, Beijing Kawin Technology Share-Holding Co., Ltd, Beijing, China. FAU - Li, Li AU - Li L AD - Research and Development Center, Beijing Kawin Technology Share-Holding Co., Ltd, Beijing, China. FAU - Pan, Hai AU - Pan H AD - Research and Development Center, Beijing Kawin Technology Share-Holding Co., Ltd, Beijing, China. FAU - Zhou, Desheng AU - Zhou D AD - Research and Development Center, Beijing Kawin Technology Share-Holding Co., Ltd, Beijing, China. FAU - Ding, Yanhua AU - Ding Y AD - The Department of Phase I Clinical Trial, the First Hospital of Jilin University, Changchun, Jilin, China. FAU - Qin, Hong AU - Qin H AD - Research and Development Center, Beijing Kawin Technology Share-Holding Co., Ltd, Beijing, China. FAU - Niu, Junqi AU - Niu J AUID- ORCID: 0000-0002-9857-6520 AD - Department of Hepatology, the First Hospital of Jilin University, Changchun, China. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20201013 PL - United States TA - Liver Int JT - Liver international : official journal of the International Association for the Study of the Liver JID - 101160857 RN - 0 (Antiviral Agents) RN - WJ6CA3ZU8B (Sofosbuvir) SB - IM MH - Adult MH - Antiviral Agents/adverse effects MH - China MH - Drug Therapy, Combination MH - Genotype MH - Hepacivirus/genetics MH - *Hepatitis C, Chronic/drug therapy MH - Humans MH - Male MH - Middle Aged MH - *Sofosbuvir/therapeutic use MH - Treatment Outcome PMC - PMC7702130 OTO - NOTNLM OT - coblopasvir OT - pangenotypic regimen OT - safety OT - sofosbuvir OT - sustained virological response COIS- Jing Ning, Hai Pan and Hong Qin were employees of Kawin Technology when executing this trial, and Li Li and Desheng Zhou are employees and stakeholders of Kawin Technology. The other authors have no conflict of interest to declare. EDAT- 2020/10/14 06:00 MHDA- 2021/06/22 06:00 PMCR- 2020/11/30 CRDT- 2020/10/13 09:21 PHST- 2020/03/02 00:00 [received] PHST- 2020/07/26 00:00 [revised] PHST- 2020/07/30 00:00 [accepted] PHST- 2020/10/14 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/10/13 09:21 [entrez] PHST- 2020/11/30 00:00 [pmc-release] AID - LIV14633 [pii] AID - 10.1111/liv.14633 [doi] PST - ppublish SO - Liver Int. 2020 Nov;40(11):2685-2693. doi: 10.1111/liv.14633. Epub 2020 Oct 13.