Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
NCT ID: NCT01858766
Last Updated: 2018-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
379 participants
INTERVENTIONAL
2013-04-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF+VEL 25 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 100 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 25 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 100 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 25 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
RBV
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)
SOF+VEL 100 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
RBV
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)
SOF+VEL 25 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
RBV
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)
SOF+VEL 100 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
RBV
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)
Interventions
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SOF
400 mg tablet administered orally once daily
VEL
Tablet administered orally once daily
RBV
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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John McNally, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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UCSD
La Jolla, California, United States
University of California San Diego Medical Center
La Jolla, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Los Angeles Medical Center
Los Angeles, California, United States
Ruane Peter J MD Incorporated
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
Huntington Medical Research Institutes Liver Center
Pasadena, California, United States
Kaiser Permanente Medical Grp
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Kaiser Permante
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
University of Florida Center for Clinical Trials Research
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
South Florida Center of Gastroenterology, P.A
Wellington, Florida, United States
Center For Hepatitis C/Atlanta Medical Center
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Indianapolis Gastroenterology & Hepatology, Inc.- ARC
Indianapolis, Indiana, United States
Mercy Medical Ctr
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
ID Care
Hillsborough, New Jersey, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States
North Shore/Long Island Jewish PRIME
Lake Success, New York, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
UPMC Center For Liver Diseases
Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists Inc.
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Methodist Transplant Physicians
Dallas, Texas, United States
Alamo Medical Research, LTD d/b/a American Research Corporation
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
INOVA Institute of Research & Education
Falls Church, Virginia, United States
The Liver Institute of Virginia
Newport News, Virginia, United States
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Fundacion de Investigacion de Diego
Santurce, , Puerto Rico
Countries
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References
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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).
Tran 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 Naïve Patients with Genotype 1-6 HCV Infection. Hepatology (2014), 60: 4 (suppl) 237A.
Doehle 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.
Everson 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.
Other Identifiers
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GS-US-342-0102
Identifier Type: -
Identifier Source: org_study_id
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