Publication:
Sofosbuvir–velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial

Issued Date

2019-02-01

Resource Type

Article

ISSN

24681253

DOI

10.1016/S2468-1253(18)30343-1

Other identifier(s)

2-s2.0-85059554222

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

The Lancet Gastroenterology and Hepatology. Vol.4, No.2 (2019), 127-134

Suggested Citation

Lai Wei, Seng Gee Lim, Qing Xie, Kính Nguyen Văn, Teerha Piratvisuth, Yan Huang, Shanming Wu, Ming Xu, Hong Tang, Jun Cheng, Hung Le Manh, Yanhang Gao, Zhuangbo Mou, Abhasnee Sobhonslidsuk, Xiaguang Dou, Satawat Thongsawat, Yuemin Nan, Chee Kiat Tan, Qin Ning, Hoi Poh Tee, Yimin Mao, Luisa M. Stamm, Sophia Lu, Hadas Dvory-Sobol, Hongmei Mo, Diana M. Brainard, Yong Feng Yang, Long Dao, Gui Qiang Wang, Tawesak Tanwandee, Peng Hu, Pisit Tangkijvanich, Lunli Zhang, Zhi Liang Gao, Feng Lin, Thi Tuyet Phuong Le, Jia Shang, Guozhong Gong, Jun Li, Minghua Su, Zhongping Duan, Rosmawati Mohamed, Jin Lin Hou, Jidong Jia Sofosbuvir–velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. The Lancet Gastroenterology and Hepatology. Vol.4, No.2 (2019), 127-134. doi:10.1016/S2468-1253(18)30343-1 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51945

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Title

Sofosbuvir–velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial

Author(s)

Lai Wei
 Seng Gee Lim
 Qing Xie
 Kính Nguyen Văn
 Teerha Piratvisuth
 Yan Huang
 Shanming Wu
 Ming Xu
 Hong Tang
 Jun Cheng
 Hung Le Manh
 Yanhang Gao
 Zhuangbo Mou
 Abhasnee Sobhonslidsuk
 Xiaguang Dou
 Satawat Thongsawat
 Yuemin Nan
 Chee Kiat Tan
 Qin Ning
 Hoi Poh Tee
 Yimin Mao
 Luisa M. Stamm
 Sophia Lu
 Hadas Dvory-Sobol
 Hongmei Mo
 Diana M. Brainard
 Yong Feng Yang
 Long Dao
 Gui Qiang Wang
 Tawesak Tanwandee
 Peng Hu
 Pisit Tangkijvanich
 Lunli Zhang
 Zhi Liang Gao
 Feng Lin
 Thi Tuyet Phuong Le
 Jia Shang
 Guozhong Gong
 Jun Li
 Minghua Su
 Zhongping Duan
 Rosmawati Mohamed
 Jin Lin Hou
 Jidong Jia

Other Contributor(s)

Jinan Infectious Disease Hospital
 The First Bethune Hospital of Jilin University
 Peking University People's Hospital
 Peking University First Hospital
 The First Affiliated Hospital of Guangxi Medical University
 Beijing YouAn Hospital, Capital Medical University
 The Second Hospital of Nanjing
 Hainan Provincial People's Hospital
 Second Xiangya Hospital of Central-South University
 Xiangya Hospital of Central-South University
 Shanghai Jiao Tong University School of Medicine
 Guangzhou Eighth People's Hospital
 Henan Provincial People's Hospital
 West China School of Medicine/West China Hospital of Sichuan University
 Beijing Friendship Hospital, Capital Medical University
 Beijing Ditan Hospital Capital Medical University
 Bach Mai Hospital
 National University Hospital, Singapore
 Songklanagarind Hospital
 King Chulalongkorn Memorial Hospital, Faculty of Medicine Chulalongkorn University
 UCL
 Sun Yat-Sen University
 Chongqing Medical University
 Singapore General Hospital
 Faculty of Medicine, Ramathibodi Hospital, Mahidol University
 Maharaj Nakorn Chiang Mai Hospital
 University of Malaya Medical Centre
 Faculty of Medicine, Siriraj Hospital, Mahidol University
 Hebei Medical University
 China Medical University Shenyang
 Nanchang University
 Gilead Sciences Incorporated
 Southern Medical University
 Tongji Medical College
 Shanghai Public Health Clinical Centre
 National Hospital for Tropical Diseases
 Jiangsu Province People's Hospital
 People's Hospital 115
 Hospital Tengku Ampuan Afzan

Abstract

© 2019 Elsevier Ltd Background: Treatment with combined sofosbuvir and velpatasvir has resulted in high sustained virological response rates in patients chronically infected with hepatitis C virus (HCV) with genotypes 1–6 in clinical trials and real-world settings, but its efficacy and safety has not been assessed in Asia, a region with diverse HCV genotypes. Methods: In this single-arm, open-label, phase 3 trial, we recruited patients from 38 sites across China, Thailand, Vietnam, Singapore, and Malaysia, who were chronically infected with HCV genotypes 1–6, and were HCV treatment-naive or treatment-experienced, either without cirrhosis or with compensated cirrhosis. Patients self-administered a combined sofosbuvir (400 mg) and velpatasvir (100 mg) tablet once daily for 12 weeks. The primary efficacy endpoint was sustained virological response, defined as HCV RNA less than 15 IU/mL at 12 weeks after completion of treatment (SVR12), assessed in all patients who received at least one dose of study drug. The primary safety endpoint was the proportion of adverse events leading to premature discontinuation of study drug. This trial is registered with ClinicalTrials.gov, number NCT02671500, and is completed. Findings: Between April 14, 2016, and June 30, 2017, 375 patients were enrolled in the study, of whom 374 completed the full treatment course and one discontinued treatment. Overall, 362 (97% [95% CI 94–98]) of 375 patients achieved SVR12. Among 42 patients with HCV genotype 3b, all of whom had baseline resistance-associated substitutions in NS5A, 25 (89% [95% CI 72–98]) of 28 patients without cirrhosis and seven (50% [23–77]) of 14 patients with cirrhosis achieved SVR12. The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients). There were no discontinuations due to adverse events. Serious adverse events were reported in three (1%) patients, none of which was judged to be related to sofosbuvir–velpatasvir treatment. Interpretation: Consistent with data from other phase 3 studies, single-tablet sofosbuvir–velpatasvir for 12 weeks is an efficacious and safe treatment for Asian patients with chronic HCV infection, but might have lower efficacy in those infected with HCV genotype 3b and with cirrhosis. Funding: Gilead Sciences.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/51945

Collections

Scopus 2019