Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.
2 other identifiers
interventional
870
7 countries
88
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2012
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
March 27, 2015
CompletedNovember 16, 2018
March 1, 2015
1.5 years
October 2, 2012
March 17, 2015
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)
SVR12 was defined as HCV RNA level \< the lower limit of quantification (LLOQ, ie, \< 25 copies/mL) 12 weeks after last dose of study drug.
Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Up to 24 weeks
Secondary Outcomes (8)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Week 2
Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8
Week 8
Change From Baseline in HCV RNA at Week 2
Baseline; Week 2
- +3 more secondary outcomes
Study Arms (4)
LDV/SOF 12 weeks
EXPERIMENTALLDV/SOF administered for 12 weeks
LDV/SOF+RBV 12 weeks
EXPERIMENTALLDV/SOF+RBV administered for 12 weeks.
LDV/SOF 24 weeks
EXPERIMENTALLDV/SOF administered for 24 weeks
LDV/SOF+RBV 24 weeks
EXPERIMENTALLDV/SOF+RBV administered for 24 weeks.
Interventions
LDV/SOF 90/400 mg FDC tablet administered orally once daily
RBV 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:
- Age ≥ 18, with chronic genotype 1 HCV infection
- HCV treatment-naive
- HCV RNA \> 10,000 IU/mL at screening
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
You may not qualify if:
- Pregnant or nursing female or male with pregnant female partner
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (88)
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Birmingham, Alabama, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Englewood, Colorado, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Wellington, Florida, United States
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Atlanta, Georgia, United States
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Decatur, 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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Lutherville, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Saint Paul, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Hillsborough, New Jersey, United States
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Albuquerque, New Mexico, United States
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Santa Fe, New Mexico, United States
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Manhasset, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, 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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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Philadelphia, Pennsylvania, 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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Houston, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States
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Falls Church, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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CHRU Lille, France
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Clichy, France
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Créteil, France
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La Tronche, France
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Lyon, France
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Marseille, France
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Nice, France
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Paris, France
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Berlin, Germany
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Cologne, Germany
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Düsseldorf, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hanover, Germany
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Mainz, Germany
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Bologna, Italy
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Brescia, Italy
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Milan, Italy
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Padua, Italy
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Palermo, Italy
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Roma, Italy
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San Giovanni Rotondo, Italy
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Torino, Italy
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San Juan, Puerto Rico
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Santander, Spain
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Seville, Spain
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Birmingham, Wstmid, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Plymouth, United Kingdom
Related Publications (3)
Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. doi: 10.1093/cid/ciw580. Epub 2016 Aug 23.
PMID: 27553375DERIVEDYounossi ZM, Elsheikh E, Stepanova M, Gerber L, Nader F, Stamm LM, Brainard DM, McHutchinson JG. Ledipasvir/sofosbuvir treatment of hepatitis C virus is associated with reduction in serum apolipoprotein levels. J Viral Hepat. 2015 Dec;22(12):977-82. doi: 10.1111/jvh.12448. Epub 2015 Aug 17.
PMID: 26280786DERIVEDAfdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.
PMID: 24725239DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Jenny Yang, Pharm D
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2012
First Posted
October 5, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
November 16, 2018
Results First Posted
March 27, 2015
Record last verified: 2015-03
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.