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

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOF/VEL
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Ditan Hospital
  • Nanfang Hospital of Southern Medical University
  • The Third Affiliated Hospital, Sun Yat-Sen University
  • The First Affiliated Hospital of Guangxi Medical University
  • Tongji Hospital Affiliated to Tongji Medicine University
  • Xiangyan Hospital, Central South University
  • Shanghai Public Health Clinical Center
  • Shanghai Ruijin Hospital
  • West China Hospital, Sichuan University
  • Peking University First Hospital
  • Peking University People's Hospital
  • Beijing Friendship Hospital Affiliate of Capital Medical University
  • The Second Affiliated Hospital of Chongqing Medical University
  • Guangzhou Eighth People's Hospital
  • The People's Hospital of Hainan Province
  • The 2nd Xiangya Hospital of Central South University
  • The Second Hospital of Nanjing
  • The First Hospital of Jilin University
  • Jinan Infectious Disease Hospital
  • Shengjing Hospital of China Medical University
  • The First Affiliated Hospital of NanChang University
  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • Shanghai Renji Hospital
  • The 3rd Hospital of Hebei Medical University
  • Henan Province People's Hospital
  • University of Malaya
  • Hospital Tengku Ampuan Afzan
  • National University Hospital
  • Singapore General Hospital
  • Chulalongkorn Hospital
  • Ramathibodi Hospital Mahidol University
  • Siriraj Hospital
  • Maharaj Nakhon Chiangmai Hospital
  • Songklanagarind Hospital
  • Bach Mai Hospital
  • National Hospital for Tropical Disease
  • People's Hospital 115
  • Ho Chi Minh City Hospital for Tropical Diseasees

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF/VEL

Arm Description

SOF/VEL FDC for 12 weeks

Outcomes

Primary Outcome Measures

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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

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.
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.
Percentage of Participants With HCV RNA < LLOQ On Treatment
Change From Baseline in HCV RNA
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.

Full Information

First Posted
January 29, 2016
Last Updated
December 20, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02671500
Brief Title
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 19, 2016 (Actual)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL FDC for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
GS-7977/GS-5816, Epclusa®
Intervention Description
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Description
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame
Posttreatment Week 24
Title
Percentage of Participants With HCV RNA < LLOQ On Treatment
Time Frame
Weeks 1, 2, 4, 6, 8, 10, and 12
Title
Change From Baseline in HCV RNA
Time Frame
Baseline and up to Week 12
Title
Percentage of Participants With Overall Virologic Failure
Description
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.
Time Frame
Up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Ditan Hospital
City
Chaoyang
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Third Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Tongji Hospital Affiliated to Tongji Medicine University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Xiangyan Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Hongkou
State/Province
Shanghai
ZIP/Postal Code
200083
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Huangpu
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Friendship Hospital Affiliate of Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Guangzhou Eighth People's Hospital
City
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
The People's Hospital of Hainan Province
City
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
The 2nd Xiangya Hospital of Central South University
City
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The Second Hospital of Nanjing
City
Jiangsu
ZIP/Postal Code
210003
Country
China
Facility Name
The First Hospital of Jilin University
City
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Jinan Infectious Disease Hospital
City
Jinan
ZIP/Postal Code
250000
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Shanghai Renji Hospital
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
The 3rd Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050051
Country
China
Facility Name
Henan Province People's Hospital
City
Zhengzhou
ZIP/Postal Code
450016
Country
China
Facility Name
University of Malaya
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Chulalongkorn Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bankok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakhon Chiangmai Hospital
City
Chiang Mai
ZIP/Postal Code
50202
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Bach Mai Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
National Hospital for Tropical Disease
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
People's Hospital 115
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Ho Chi Minh City Hospital for Tropical Diseasees
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.gilead.com/research/disclosure-and-transparency
Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
30555048
Citation
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.
Results Reference
derived

Learn more about this trial

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

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