Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
NCT ID: NCT01909804
Last Updated: 2018-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
323 participants
INTERVENTIONAL
2013-06-30
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 (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
SOF
400 mg tablet administered orally once daily
SOF+VEL 25mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 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 (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis 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 100 mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 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 (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis 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 25 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
SOF
400 mg 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 (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis 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 100 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 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 (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 25 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 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 (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 100 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 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
* 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
Exclusion Criteria
* 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
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
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Long Beach, California, United States
Los Angeles, California, United States
Pasadena, California, United States
San Diego, California, United States
Denver, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Hillsborough, New Jersey, United States
Santa Fe, New Mexico, United States
Great Neck, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Annandale, Virginia, United States
Fairfax, Virginia, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Clayton, Victoria, Australia
Melbourne, Victoria, Australia
Fremantle, Western Australia, Australia
Perth, Western Australia, Australia
Auckland, , New Zealand
Christchurch, , New Zealand
San Juan, , Puerto Rico
Countries
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References
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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.
Pianko 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.
Other Identifiers
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GS-US-342-0109
Identifier Type: -
Identifier Source: org_study_id
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