Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection
1 other identifier
interventional
323
4 countries
49
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2013
Shorter than P25 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
September 16, 2016
CompletedNovember 15, 2018
July 1, 2016
11 months
July 17, 2013
July 27, 2016
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (12)
SOF+VEL 25 mg (GT3) without cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 25mg+RBV (GT3) without cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
SOF+VEL 100 mg (GT3) without cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 100 mg+RBV (GT3) without cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
SOF+VEL 25 mg (GT3) with cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 25 mg+RBV (GT3) with cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
SOF+VEL 100 mg (GT3) with cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 100 mg+RBV (GT3) with cirrhosis
EXPERIMENTALParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
SOF+VEL 25 mg (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 25 mg+RBV (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
SOF+VEL 100 mg (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 100 mg+RBV (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Interventions
400 mg tablet administered orally once daily
Tablet administered orally once daily
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) ≥ 18 kg/m\^2
- HCV RNA ≥ 10000 IU/mL at screening
- Prior treatment failure to a regimen including interferon with or without RBV
- HCV genotype 1 or 3
- Chronic HCV infection
- Cirrhosis determination
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
You may not qualify if:
- Current or prior history of clinically significant illness other than HCV
- Screening ECG with clinically significant abnormalities
- Prior exposure to HCV specific direct acting antiviral agent
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of non-HCV etiology
- Hepatitis B
- Active drug abuse
- Use of any prohibited concomitant medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (49)
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
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Orlando, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Wellington, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Hillsborough, New Jersey, United States
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Santa Fe, New Mexico, United States
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Great Neck, New York, United States
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New York, New York, United States
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Annandale, Virginia, United States
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Fairfax, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Camperdown, New South Wales, Australia
Unknown Facility
Darlinghurst, New South Wales, Australia
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Clayton, Victoria, Australia
Unknown Facility
Melbourne, Victoria, Australia
Unknown Facility
Fremantle, Western Australia, Australia
Unknown Facility
Perth, Western Australia, Australia
Unknown Facility
Auckland, New Zealand
Unknown Facility
Christchurch, New Zealand
Unknown Facility
San Juan, Puerto Rico
Related Publications (2)
Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. High Efficacy of Treatment with Sofosbuvir+GS-5816±Ribavirin for 12 Weeks in Treatment-Experienced Patients with Genotype 1 or 3 HCV Infection [Abstract 197]. American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston MA United States.
RESULTPianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Rabinovitz M, Towner WJ, Gane EJ, Stedman CA, Reddy KR, Roberts SK. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):809-17. doi: 10.7326/M15-1014. Epub 2015 Nov 10.
PMID: 26551263RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
John McNally
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2013
First Posted
July 29, 2013
Study Start
June 1, 2013
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
November 15, 2018
Results First Posted
September 16, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
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.