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Official Title Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial
Phase Phase III
ClinicalTrials.gov NCT02105688
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Dore GJ, Altice F, Litwin AH, et al. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016;165:625-634.
Official Title Efficacy and Safety of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Patients with Hepatitis C Virus and HIV Co-Infection (C-EDGE CO-INFECTION): a Non-Randomised, Open-Label Trial
Phase Phase III
ClinicalTrials.gov NCT02105662
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015;2:e319-27.
Official Title Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection
Phase Phase III
ClinicalTrials.gov NCT02105701
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Kwo P, Gane EJ, Peng CY, et al. Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection. Gastroenterology. 2017;152:164-175.e4.
Official Title Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial
Phase Phase III
ClinicalTrials.gov NCT02105467
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Zeuzem S, Ghalib R, Reddy KR, et al. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015;163:1-13.
Official Title Grazoprevir plus Elbasvir in Treatment-Naive and Treatment-Experienced Patients with Hepatitis C Virus Genotype 1 Infection and Stage 4-5 Chronic Kidney Disease (the C-SURFER study): a Combination Phase 3 Study.
Phase Phase III
ClinicalTrials.gov NCT02092350
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Roth D, Nelson DR, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386:1537-45.
Official Title Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Jacobson IM, Lawitz E, Kwo PY, et al. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017;152:1372-1382.e2.
Official Title Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Phase Phase III
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Asselah T, Reesink H, Gerstoft J, et al. Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis. Liver Int. 2018;38:1583-91.
Common TitleC-ISLE Industry
Official Title Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial.
Phase Phase II
ClinicalTrials.gov NCT02601573
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Foster GR, Agarwal K, Cramp ME, et al. Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial. Hepatology. 2018;67:2113-2126.
Common TitleC-SALVAGE Industry
Official Title Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE
Phase Phase II
ClinicalTrials.gov NCT02105454
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Buti M, Gordon SC, Zuckerman E, et al. Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE. Clin Infect Dis. 2016;62:32-6.
Common TitleC-SCAPE
Official Title Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C-SCAPE study.
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedReferences
- Brown A, Hézode C, Zuckerman E, et al. Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C-SCAPE study. J Viral Hepat. 2018;25:457-64.
Common TitleC-SWIFT Industry
Official Title Short-Duration Treatment with Elbasvir/Grazoprevir and Sofosbuvir for Hepatitis C: a Randomized Trial
Phase Phase II
ClinicalTrials.gov NCT02133131
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Lawitz E, Poordad F, Gutierrez JA, et al. Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology. 2017;65:439-450.
Common TitleC-WORTHY Industry
Official Title Efficacy and Safety of 12 Weeks versus 18 Weeks of Treatment with Grazoprevir (MK-5172) and Elbasvir (MK-8742) with or without Ribavirin for Hepatitis C Virus Genotype 1 Infection in Previously Untreated Patients with Cirrhosis and Patients with Previous Null Response with or without Cirrhosis (C-WORTHY): a Randomised, Open-Label Phase 2 Trial.
Phase Phase II
ClinicalTrials.gov NCT01717326
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Lawitz E, Gane E, Pearlman B, et al. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015;385:1075-86.
Common TitleC-WORTHY Coinfection Industry
Official Title Efficacy and Safety of 8 weeks versus 12 weeks of Treatment with Grazoprevir (MK-5172) and Elbasvir (MK-8742) with or without Ribavirin in Patients with Hepatitis C virus Genotype 1 Mono-Infection and HIV/hepatitis C virus Co-Infection (C-WORTHY): a Randomised, Open-Label Phase 2 Trial.
Phase Phase II
ClinicalTrials.gov NCT01717326
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Sulkowski M, Hezode C, Gerstoft J, et al. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015;385:1087-97.
Common TitleSwiss HCVree Trial Industry
Official Title A Phase III, Multi-center, Open-label Trial to Investigate the Impact of a Treat, Counsel and Cure Strategy in Men Who Have Sex With Men With Hepatitis C Infection in the Swiss HIV Cohort Study
Phase Phase III
ClinicalTrials.gov NCT02785666
Treatments
Elbasvir-Grazoprevir
Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.
References
- Braun DL, Hampel B, Kouyos R, et al. High Cure Rates With Grazoprevir-Elbasvir With or Without Ribavirin Guided by Genotypic Resistance Testing Among Human Immunodeficiency Virus/Hepatitis C Virus-coinfected Men Who Have Sex With Men. Clin Infect Dis. 2019;68:569-76.
Elbasvir-Grazoprevir Slide Deck
March 30, 2022
Clinical Trial Image Decks
C-EDGE CO-STAR - April 1, 2022
C-EDGE Coinfection - March 30, 2022
C-EDGE Treatment-Experienced - March 30, 2022
C-EDGE Treatment-Naïve - March 30, 2022
C-SURFER - March 30, 2022
Integrated Analysis of Treatment in Persons with Compensated Cirrhosis PDF Integrated Analysis of Treatment in Persons with Compensated Cirrhosis PPTX
Integrated Analysis of Treatment in Persons with Compensated Cirrhosis - March 30, 2022
Pooled Analysis with HCV GT4 - March 30, 2022