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Official Title Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection
Phase Phase III
ClinicalTrials.gov NCT01701401
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889-98.
Official Title Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection.
Phase Phase III
ClinicalTrials.gov NCT01768286
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483-93.
Official Title Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis
Phase Phase III
ClinicalTrials.gov NCT01851330
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879-88.
Official Title Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1
Phase Phase III
ClinicalTrials.gov NCT02073656
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Naggie S, Cooper C, Saag M, et al. Ledipasvir and sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:705-13.
Official Title Ledipasvir-sofosbuvir with or without Ribavirin to Treat Patients with HCV Genotype 1 Infection and Crrhosis Non-Responsive to Previous Protease-Inhibitor Therapy: a Randomised, Double-Blind, Phase 2 Trial (SIRIUS)
Phase Phase II
ClinicalTrials.gov NCT01965535
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Bourlière M, Bronowicki JP, de Ledinghen V, et al. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015;15:397-404.
Official Title Ledipasvir and Sofosbuvir plus Ribavirin for Treatment of HCV Infection in Patients with Advanced Liver Disease.
Phase Phase II
ClinicalTrials.gov NCT01938430
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Charlton M, Everson GT, Flamm SL, et al. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease. Gastroenterology. 2015;149:649-59.
Official Title Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial
Phase Phase II
ClinicalTrials.gov NCT02010255
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Manns M, Samuel D, Gane EJ, et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016;16:685-97.
Common TitleEgyptian GT4 Multicenter Study Industry
Official Title Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt.
Phase Phase III
ClinicalTrials.gov NCT02487030
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Shiha G, Esmat G, Hassany M, et al. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019;68:721-8.
Common TitleELECTRON (Arms 12-17 and 22) Industry
Official Title Efficacy of Nucleotide Polymerase Inhibitor Sofosbuvir plus the NS5A Inhibitor Ledipasvir or the NS5B Non-Nucleoside inhibitor GS-9669 Against HCV Genotype 1 Infection.
Phase Phase II
ClinicalTrials.gov NCT01260350
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Gane EJ, Stedman CA, Hyland RH, et al. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014;146:736-43.
Common TitleERCHIVES-Renal Non-Industry Industry
Official Title Effectiveness, Treatment Completion and Safety of Sofosbuvir-Ledipasvir and Paritaprevir-Ritonavir-Ombitasvir plus Dasabuvir in Patients with Chronic Kidney Disease: an ERCHIVES Study.
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
Non-IndustryVA Pittsburgh Healthcare System.
References
- Butt AA, Ren Y, Puenpatom A, Arduino JM, Kumar R, Abou-Samra AB. Effectiveness, treatment completion and safety of sofosbuvir/ledipasvir and paritaprevir/ritonavir/ombitasvir + dasabuvir in patients with chronic kidney disease: an ERCHIVES study. Aliment Pharmacol Ther. 2018;48:35-43.
Common TitleLONESTAR Industry
Official Title Sofosbuvir and Ledipasvir Fixed-Dose Combination with and without Ribavirin in Treatment-Naive and Previously Treated Patients with Genotype 1 Hepatitis C Virus Infection (LONESTAR): an Open-Label, Randomised, Phase 2 Trial
Phase Phase II
ClinicalTrials.gov NCT01329978
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014;383:515-23.
Common TitleNew Zealand Genotype 3 and 6 Trial Industry
Official Title Efficacy of Ledipasvir and Sofosbuvir, with or without Ribavirin, for 12 Weeks inPatients with HCV Genotype 3 or 6 Infection
Phase Phase II
ClinicalTrials.gov NCT01826981
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Gane EJ, Hyland RH, An D, et al. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015;149:1454-1461.e1.
Common TitleNIAID ERADICATE Non-Industry
Official Title Virologic Response following Combined Ledipasvir and Sofosbuvir Administration in Patients with HCV Genotype 1 and HIV Co-Infection
Phase Phase II
ClinicalTrials.gov NCT01878799
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Osinusi A, Townsend K, Kohli A, et al. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. JAMA. 2015;313:1232-9.
Common TitleNIAID Retreatment of Sofosbuvir Failures (Genotype 1) Non-Industry
Official Title Re-Treatment of Chronic Hepatitis C Virus Genotype 1 Infection after Relapse: an Open-Label Pilot Study.
Phase Phase II
ClinicalTrials.gov NCT01805882
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Osinusi A, Kohli A, Marti MM, et al. Re-treatment of chronic hepatitis C virus genotype 1 infection after relapse: an open-label pilot study. Ann Intern Med. 2014;161:634-8.
Common TitleNIAID SYNERGY (Genotype 1) Non-Industry
Official Title Virological Response after 6 Week Triple-Drug Regimens for Hepatitis C: a Proof-of-Concept Phase 2A Cohort Study
Phase Phase II
ClinicalTrials.gov NCT01805882
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Kohli A, Osinusi A, Sims Z, et al. Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Lancet. 2015;385:1107-13.
Common TitleNIAID SYNERGY (Genotype 4) Non-Industry
Official Title Ledipasvir and Sofosbuvir for Hepatitis C Genotype 4: a Proof-of-Concept, Single-Centre, Open-Label Phase 2a Cohort Study
Phase Phase II
ClinicalTrials.gov NCT01805882
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Kohli A, Kapoor R, Sims Z, et al. Ledipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort study. Lancet Infect Dis. 2015;15:1049-54.
Common TitleRetreatment of Sofosbuvir Failures from prior Clinical Trials Industry
Official Title Ledipasvir-Sofosbuvir plus Ribavirin for Patients with Genotype 1 Hepatitis C Virus Previously Treated in Clinical Trials of Sofosbuvir Regimens
Treatments
Ledipasvir-Sofosbuvir
Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Wyles D, Pockros P, Morelli G, et al. Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens. Hepatology. 2015;61:1793-7.
Ledipasvir-Sofosbuvir Slide Deck
July 5, 2022
Clinical Trial Image Decks
ION-1 - July 5, 2022
ION-2 - July 5, 2022
ION-3 - July 5, 2022
ION-4 - July 5, 2022
SIRIUS - July 5, 2022
SOLAR-1: (Cohorts A and B) - July 5, 2022
SOLAR-2 - July 5, 2022