Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults 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-Naive Subjects With Chronic HCV Infection
1 other identifier
interventional
379
2 countries
51
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, 2, 3, 4, 5, or 6 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 Apr 2013
Shorter than P25 for phase_2
51 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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 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 15, 2016
CompletedNovember 14, 2018
July 1, 2016
1.1 years
May 10, 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 (14)
SOF+VEL 25 mg 12 Weeks (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 100 mg 12 Weeks (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
EXPERIMENTALParticipants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
EXPERIMENTALParticipants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 25 mg 12 Weeks (GT3)
EXPERIMENTALParticipants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 100 mg 12 Weeks (GT3)
EXPERIMENTALParticipants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 25 mg 8 Weeks (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
SOF+VEL 100 mg 8 Weeks (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
EXPERIMENTALParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
SOF+VEL 25 mg 8 Weeks (GT2)
EXPERIMENTALParticipants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
EXPERIMENTALParticipants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
SOF+VEL 100 mg 8 Weeks (GT2)
EXPERIMENTALParticipants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
EXPERIMENTALParticipants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 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:
- Chronic HCV infection
- Body mass index (BMI) ≥ 18 kg/m\^2
- HCV RNA ≥ 10000 IU/mL at screening
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
- Must not have cirrhosis
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
- Prior treatment of HCV with interferon or ribavirin
- 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 (51)
UCSD
La Jolla, California, 92037, United States
University of California San Diego Medical Center
La Jolla, California, 92093, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Los Angeles Medical Center
Los Angeles, California, 90027, United States
Ruane Peter J MD Incorporated
Los Angeles, California, 90036, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
National Research Institute
Los Angeles, California, 90057, United States
Huntington Medical Research Institutes Liver Center
Pasadena, California, 91105, United States
Kaiser Permanente Medical Grp
San Diego, California, 92120, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Kaiser Permante
San Francisco, California, 94080, United States
University of Colorado
Denver, Colorado, 80220, United States
University of Florida Center for Clinical Trials Research
Gainesville, Florida, 32610, United States
Borland-Groover Clinic
Jacksonville, Florida, 32216, United States
University of Miami
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
South Florida Center of Gastroenterology, P.A
Wellington, Florida, 33414, United States
Center For Hepatitis C/Atlanta Medical Center
Atlanta, Georgia, 30344, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology & Hepatology, Inc.- ARC
Indianapolis, Indiana, 46237, United States
Mercy Medical Ctr
Baltimore, Maryland, 21202, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
ID Care
Hillsborough, New Jersey, 08844, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505, United States
North Shore/Long Island Jewish PRIME
Lake Success, New York, 11041, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10021, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28303, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
UPMC Center For Liver Diseases
Pittsburgh, Pennsylvania, 15213, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Gastro One
Germantown, Tennessee, 38138, United States
Nashville Gastrointestinal Specialists Inc.
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Methodist Transplant Physicians
Dallas, Texas, 75203, United States
Alamo Medical Research, LTD d/b/a American Research Corporation
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
INOVA Institute of Research & Education
Falls Church, Virginia, 22042, United States
The Liver Institute of Virginia
Newport News, Virginia, 23602, United States
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Fundacion de Investigacion de Diego
Santurce, 00909, Puerto Rico
Related Publications (4)
Everson GT, Tran TT, Towner WJ , Davis MN, Wyles D, Nahass R, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, Symonds WT, McHutchison JG, Morgan T, Chung RT. Safety and Efficacy of Treatment with the Interferon-Free, Ribavirin-Free Combination of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Naive Patients with Genotype 1-6 HCV Infection. Journal of Hepatology, Volume 60, Issue 1, Supplement, Page S46. April 2014 (EASL 2014).
RESULTTran TT, Morgan TR, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Chung RT, Everson GT. Safety and Efficacy of Treatment with Sofosbuvir+ GS-5816±Ribavirin for 8 or 12 Weeks in Treatment NaĂ¯ve Patients with Genotype 1-6 HCV Infection. Hepatology (2014), 60: 4 (suppl) 237A.
RESULTDoehle B, Gontcharova V, Chodavarapu1 RK, McNally J, Chung RT, Everson GT, McHutchison JG, Miller MD, Mo H. Resistance Analysis of Treatment-Naive HCV Genotype 1-6 Infected Patients Treated with Sofosbuvir in Combination with GS-5816 for 12 Weeks. Hepatology (2014), 60: 4 (suppl) 1138A.
RESULTEverson GT, Towner WJ, Davis MN, Wyles DL, Nahass RG, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, Rabinovitz M, McNally J, Brainard DM, Han L, Doehle B, McHutchison JG, Morgan T, Chung RT, Tran TT. Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):818-26. doi: 10.7326/M15-1000. Epub 2015 Nov 10.
PMID: 26551051RESULT
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, PhD
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
May 10, 2013
First Posted
May 21, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
November 14, 2018
Results First Posted
September 15, 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.