Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
1 other identifier
interventional
647
1 country
52
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants 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 May 2013
Shorter than P25 for phase_3
52 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
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 3, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
December 30, 2014
CompletedNovember 16, 2018
December 1, 2014
7 months
May 3, 2013
December 18, 2014
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 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 12 weeks
Secondary Outcomes (8)
Percentage of Participants With Sustained Virologic Response 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 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 (3)
LDV/SOF 8 Week
EXPERIMENTALParticipants will receive LDV/SOF FDC for 8 weeks.
LDV/SOF+RBV 8 Week
EXPERIMENTALParticipants will receive LDV/SOF FDC plus RBV for 8 weeks.
LDV/SOF 12 Week
EXPERIMENTALParticipants will receive LDV/SOF FDC for 12 weeks.
Interventions
LDV 90 mg/SOF 400 mg 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-naive
- HCV RNA \> 10,000 IU/mL at screening
- 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
- Presence of cirrhosis
- Coinfection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- 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 (52)
Unknown Facility
Birmingham, Alabama, 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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Sacramento, 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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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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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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Novi, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Albuquerque, New Jersey, United States
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Berlin, New Jersey, United States
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Hillsborough, New Jersey, 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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Chapel Hill, 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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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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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, 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: 27553375DERIVEDKowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, Shiffman ML, Schiff E, Ghalib R, Ryan M, Rustgi V, Chojkier M, Herring R, Di Bisceglie AM, Pockros PJ, Subramanian GM, An D, Svarovskaia E, Hyland RH, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Pound D, Fried MW; ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15;370(20):1879-88. doi: 10.1056/NEJMoa1402355. Epub 2014 Apr 10.
PMID: 24720702DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Robert H. Hyland, DPhil
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
May 3, 2013
First Posted
May 10, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
November 16, 2018
Results First Posted
December 30, 2014
Record last verified: 2014-12
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.