Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
NCT ID: NCT02600351
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
87 participants
INTERVENTIONAL
2015-11-11
2017-05-29
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, without cirrhosis
LDV/SOF for 12 weeks
LDV/SOF
90/400 mg FDC tablet administered orally once daily
LDV/SOF + RBV 12 weeks, without cirrhosis
LDV/SOF + RBV for 12 weeks
LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
LDV/SOF + RBV 12 weeks, with compensated cirrhosis
LDV/SOF + RBV for 12 weeks
LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
LDV/SOF 24 weeks, with compensated cirrhosis
LDV/SOF for 24 weeks
LDV/SOF
90/400 mg FDC tablet administered orally once daily
Interventions
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LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose according to 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 genotype 1 or 4
* Chronic HCV infection (≥ 6 months)
* Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
* Cirrhotic and non-cirrhotic as determined by standard methods
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Exclusion Criteria
* Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
* 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 individual's 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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Little Rock, Arkansas, United States
Los Angeles, California, United States
Pasadena, California, United States
Rialto, California, United States
Sacramento, California, United States
Ventura, California, United States
New Haven, Connecticut, United States
Largo, Florida, United States
Weston, Florida, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Worcester, Massachusetts, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Egg Harbor, New Jersey, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Ponce, PR, Puerto Rico
Countries
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References
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Tam E, Brown RS, Satapathy S, Shen X, Camus G, Copans A, et al. Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF), with or without Ribavirin (RBV), for Treatment of HCV-mono and HIV/HCV Co-infected Patients Who Have Failed Prior Treatment with Non-NS5A, SOF-based Therapies [Poster THU-265]. The International Liver Congress™ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands.
Tam E, Mantry PS, Satapathy SK, Ghali P, Shen X, Han LL, et al. A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF), with or without Ribavirin (RBV), in HCV Infected Subjects Who Have Failed Prior Treatment with Non-NS5A, SOF-based Therapies (RESCUE) [Poster PP0217]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China.
Tam E, Brown RS, Satapathy S, Camus G, Copans A, Rossaro L, et al. Ledipasvir/Sofosbuvir ± Ribavirin in HCV and HIV/HCV Prior SOF-based Virologic Failures (RESCUE and ACTG A5348 Studies) [Poster 568LB]. Conference on Retroviruses and Opportunistic Infections (CROI); 2017 13-16 February; Seattle, WA.
Tam E, Luetkemeyer AF, Mantry PS, Satapathy SK, Ghali P, Kang M, Haubrich R, Shen X, Ni L, Camus G, Copans A, Rossaro L, Guyer B, Brown RS Jr; RESCUE and ACTG A5348 study investigators. Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naive patients: Findings from two randomized trials. Liver Int. 2018 Jun;38(6):1010-1021. doi: 10.1111/liv.13616. Epub 2017 Dec 5.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-337-1746
Identifier Type: -
Identifier Source: org_study_id
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