Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus Infection
• Intervention / Treatment: Drug: SOF/VEL

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital Affiliate of Capital Medical University
  • Chongqing, China, 400010
    • The Second Affiliated Hospital of Chongqing Medical University
  • Guangdong, China, 510060
    • Guangzhou Eighth People's Hospital
  • Hainan, China, 570311
    • The People's Hospital of Hainan Province
  • Hunan, China, 410011
    • The 2nd Xiangya Hospital of Central South University
  • Jiangsu, China, 210003
    • The Second Hospital of Nanjing
  • Jilin, China, 130021
    • The First Hospital of Jilin University
  • Jinan, China, 250000
    • Jinan Infectious Disease Hospital
  • Liaoning, China, 110004
    • Shengjing Hospital of China Medical University
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Shanghai, China, 200001
    • Shanghai Renji Hospital
  • Shanghai, China, 200001
    • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • Shijiazhuang, China, 050051
    • The 3rd Hospital of Hebei Medical University
  • Zhengzhou, China, 450016
    • Henan Province People's Hospital
  • Beijing
    • Chaoyang, Beijing, China, 100015
      • Beijing Ditan Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital, Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medicine University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangyan Hospital, Central South University
  • Shanghai
    • Hongkou, Shanghai, China, 200083
      • Shanghai Public Health Clinical Center
    • Huangpu, Shanghai, China, 200025
      • Shanghai Ruijin Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University of Malaya
  • Pahang, Malaysia, 25100
    • Hospital Tengku Ampuan Afzan
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital Mahidol University
  • Bankok, Thailand, 10700
    • Siriraj Hospital
  • Chiang Mai, Thailand, 50202
    • Maharaj Nakhon Chiangmai Hospital
  • Songkla, Thailand, 90110
    • Songklanagarind Hospital
• Vietnam
  • Hanoi, Vietnam, 100000
    • Bach Mai hospital
  • Hanoi, Vietnam, 100000
    • National Hospital for Tropical Disease
  • Ho Chi Minh, Vietnam, 700000
    • Ho Chi Minh City Hospital for Tropical Diseasees
  • Ho Chi Minh City, Vietnam, 700000
    • People's Hospital 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Willing and able to provide written informed consent
• HCV RNA ≥ 10^4 IU/mL at screening
• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
• Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
• HCV treatment-naive or treatment-experienced
• Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)

Key Exclusion Criteria:

• Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
• Pregnant or nursing female or male with pregnant female partner
• Chronic liver disease of a non HCV etiology
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOF/VEL; SOF/VEL FDC for 12 weeks	Drug: SOF/VEL; SOF/VEL (400/100 mg) FDC tablet administered orally once daily; Other Names: Epclusa®; GS-7977/GS-5816

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.	Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ On Treatment		Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA		Baseline and up to Week 12
Percentage of Participants With Overall Virologic Failure	Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.	Up to Posttreatment Week 24

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Lim SG, Rosmawati M, Phuong L, Hoi PT, McNabb BL, Lu S, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-6 HCV Infected Population from Singapore, Malaysia, Thailand, and Vietnam: Results from a Phase 3, Clinical Trial [Abstract 1094]. Hepatology 2017; 66 (1 Suppl): 586A.
• Wei L, Xie Q, Huang Y, Wu S, Xu M, Tang H, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in Genotype 1-6 HCV-Infected Patients in China: Results from a Phase 3 Clinical Trial. [Abstract 637]. Hepatology 2018; 68 (1 Suppl): 379A.
• Wei L, Lim SG, Xie Q, Van KN, Piratvisuth T, Huang Y, Wu S, Xu M, Tang H, Cheng J, Le Manh H, Gao Y, Mou Z, Sobhonslidsuk A, Dou X, Thongsawat S, Nan Y, Tan CK, Ning Q, Tee HP, Mao Y, Stamm LM, Lu S, Dvory-Sobol H, Mo H, Brainard DM, Yang YF, Dao L, Wang GQ, Tanwandee T, Hu P, Tangkijvanich P, Zhang L, Gao ZL, Lin F, Le TTP, Shang J, Gong G, Li J, Su M, Duan Z, Mohamed R, Hou JL, Jia J. Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):127-134. doi: 10.1016/S2468-1253(18)30343-1. Epub 2018 Dec 14.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2016
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
• Other Study ID Numbers: GS-US-342-1518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes