Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT ID: NCT01987453
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2014-07-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDV/SOF+RBV 12 weeks (Group 1)
Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.
LDV/SOF
Tablet(s) 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)
Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.
LDV/SOF 24 weeks (Group 2)
Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks.
LDV/SOF
Tablet(s) administered orally once daily
LDV/SOF+RBV 24 weeks (Group 3)
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.
LDV/SOF
Tablet(s) 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)
Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.
Interventions
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LDV/SOF
Tablet(s) 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)
Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infection with HCV genotype 1
* HCV RNA \> LLOQ at screening
* Participation in a prior Gilead-sponsored study
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
* Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
* Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion Criteria
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)
* Hepatocellular carcinoma (HCC)
* 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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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Beverly Hills, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Oceanside, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, 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
Wellington, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Downers Grove, Illinois, United States
Indianapolis, Indiana, United States
Bowling Green, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Hillsborough, New Jersey, United States
Albuquerque, 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
Winston-Salem, North Carolina, United States
Philadelphia, Pennsylvania, United States
Germantown, Tennessee, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Clichy, , France
San Juan, , Puerto Rico
Barcelona, , Spain
Countries
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References
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Lawitz E, Pockros PJ, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Ledipasvir/sofosbuvir regimens for the retreatment of patients who failed sofosbuvir-based regimens [Abstract 10868]. Presented at: The 25th Conference of the Asian Pacific Association for the Study of Liver (APASL); 2016 February 20-24; Tokyo, Japan.
Lawitz E, Flamm S, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Retreatment of patients who failed 8 or 12 weeks of ledipasvir/sofosbuvir-based regimens with ledipasvir/sofosbuvir for 24 weeks [Abstract 1627]. Presented at: The 50th Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2015 April 22-26; Vienna, Austria
Wyles D, Pockros P, Morelli G, Younes Z, Svarovskaia E, Yang JC, Pang PS, Zhu Y, McHutchison JG, Flamm S, Lawitz E. Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens. Hepatology. 2015 Jun;61(6):1793-7. doi: 10.1002/hep.27814. Epub 2015 Apr 27.
Other Identifiers
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2014-001245-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-337-1118
Identifier Type: -
Identifier Source: org_study_id
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