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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.