Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
NCT ID: NCT01768286
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
441 participants
INTERVENTIONAL
2013-01-31
2014-02-28
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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LDV/SOF 12 Weeks
Participants will receive LDV/SOF FDC for 12 weeks.
LDV/SOF
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
LDV/SOF+RBV 12 Weeks
Participants will receive LDV/SOF FDC plus RBV for 12 weeks.
LDV/SOF
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
RBV
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)
LDV/SOF 24 Weeks
Participants will receive LDV/SOF FDC for 24 weeks.
LDV/SOF
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
LDV/SOF+RBV 24 Weeks
Participants will receive LDV/SOF FDC plus RBV for 24 weeks.
LDV/SOF
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
RBV
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)
Interventions
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LDV/SOF
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
RBV
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Jenny Yang, PharmD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Bowling Green, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Saint Louis, Minnesota, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Berlin, New Jersey, United States
Hillsborough, New Jersey, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
Binghamton, New York, United States
Manhasset, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Countries
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References
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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.
Afdhal 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.
Other Identifiers
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GS-US-337-0109
Identifier Type: -
Identifier Source: org_study_id
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