Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
ION-2
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
1 other identifier
interventional
441
1 country
53
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2013
Shorter than P25 for phase_3
53 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
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
November 26, 2014
CompletedNovember 16, 2018
November 1, 2014
10 months
January 10, 2013
November 21, 2014
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, 25 IU/mL) 12 weeks following the 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 (12)
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 HCV RNA < LLOQ at Week 1
Week 1
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
- +7 more secondary outcomes
Study Arms (4)
LDV/SOF 12 Weeks
EXPERIMENTALParticipants will receive LDV/SOF FDC for 12 weeks.
LDV/SOF+RBV 12 Weeks
EXPERIMENTALParticipants will receive LDV/SOF FDC plus RBV for 12 weeks.
LDV/SOF 24 Weeks
EXPERIMENTALParticipants will receive LDV/SOF FDC for 24 weeks.
LDV/SOF+RBV 24 Weeks
EXPERIMENTALParticipants will receive LDV/SOF FDC plus RBV for 24 weeks.
Interventions
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
Ribavirin (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-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
- 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
- Coinfection with HIV or hepatitis B virus
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma 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 (53)
Unknown Facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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La Jolla, 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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San Diego, California, United States
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San Francisco, 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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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, 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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Bowling Green, Kentucky, United States
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Baton Rouge, Louisiana, 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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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Saint Louis, 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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Berlin, New Jersey, 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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Binghamton, New York, 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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Asheville, North Carolina, United States
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Charlotte, 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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Philadelphia, 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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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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Newport News, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Related Publications (2)
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: 27553375DERIVEDAfdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.
PMID: 24725238DERIVED
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, PharmD
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
January 10, 2013
First Posted
January 15, 2013
Study Start
January 1, 2013
Primary Completion
November 1, 2013
Study Completion
February 1, 2014
Last Updated
November 16, 2018
Results First Posted
November 26, 2014
Record last verified: 2014-11
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.