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Official Title Simeprevir Increases Rate of Sustained Virologic Response Among Treatment-Experienced Patients with HCV Genotype-1 Infection: A Phase IIb Trial
Phase Phase II
ClinicalTrials.gov NCT00980330
Treatments
Simeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryTibotec Pharmaceuticals, Ireland
References
- Zeuzem S, Berg T, Gane E, et al. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb Trial. Gastroenterology. 2014;146:430-41.
Official Title Simeprevir versus Telaprevir with Peginterferon and Ribavirin in Previous Null or Partial Responders with Chronic Hepatitis C Virus Genotype 1 Infection (ATTAIN): A Randomised, Double-Blind, Non-Inferiority Phase 3 Trial
Phase Phase III
ClinicalTrials.gov NCT01485991
Treatments
Simeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Reddy KR, Zeuzem S, Zoulim F, et al. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2014;15:27-35.
Official Title Simeprevir (TMC435) with Pegylated Interferon/Ribavirin in Patients Coinfected with HCV Genotype 1 and HIV-1: A Phase 3 Study
Phase Phase III
ClinicalTrials.gov NCT01479868
Treatments
Simeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Dieterich D, Rockstroh JK, Orkin C, et al. Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Dis. 2014;59:1579-87.
Common TitleCOSMOS Industry
Official Title Simeprevir plus Sofosbuvir, with or without Ribavirin, to Treat Chronic Infection with Hepatitis C Virus Genotype 1 in Non-Responders to Pegylated Interferon and Ribavirin and Treatment-Naive Patients: the COSMOS Randomised Study
Phase Phase II
ClinicalTrials.gov NCT01466790
Treatments
Sofosbuvir
, Sofosbuvir
Tradename:SovaldiOther Names:SOFClass:FDA-ApprovedSimeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Lawitz E, Sulkowski MS, Ghalib R, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014;384:1756-65.
Common TitleOPTIMIST-1 Industry
Official Title Simeprevir Plus Sofosbuvir (12 and 8 Weeks) in HCV Genotype 1-Infected Patients Without Cirrhosis: OPTIMIST-1, a Phase 3, Randomized Study
Phase Phase III
ClinicalTrials.gov NCT02114177
Treatments
Sofosbuvir
, Sofosbuvir
Tradename:SovaldiOther Names:SOFClass:FDA-ApprovedSimeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Kwo P, Gitlin N, Nahass R, et al. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology. 2016;64:370-80.
Common TitleOPTIMIST-2 Industry
Official Title Simeprevir plus Sofosbuvir in Patients with Chronic Hepatitis C Virus Genotype 1 Infection and Cirrhosis: A Phase 3 Study (OPTIMIST-2).
Phase Phase III
ClinicalTrials.gov NCT02114151
Treatments
Sofosbuvir
, Sofosbuvir
Tradename:SovaldiOther Names:SOFClass:FDA-ApprovedSimeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Lawitz E, Matusow G, DeJesus E, et al. Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2). Hepatology. 2016;64:360-9.
Official Title Simeprevir with Peginterferon and Ribavirin Leads to High Rates of SVR in Patients with HCV Genotype 1 who Relapsed after Previous Therapy: A Phase 3 Trial
Phase Phase III
ClinicalTrials.gov NCT01281839
Treatments
Simeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Forns X, Lawitz E, Zeuzem S, et al. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014;146:1669-79.e3.
Official Title Simeprevir with Pegylated Interferon alfa 2a Plus Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Genotype 1 Infection (QUEST-1): A Phase 3, Randomised, Double-Blind, Placebo-Controlled Trial
Phase Phase III
ClinicalTrials.gov NCT01289782
Treatments
Simeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2014;384:403-13.
Official Title Simeprevir with Pegylated Interferon alfa 2a or 2b Plus Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Genotype 1 Infection (QUEST-2): A Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial
Phase Phase III
ClinicalTrials.gov NCT01290679
Treatments
Simeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Manns M, Marcellin P, Poordad F, et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014;384:414-26.
Official Title Efficacy and Safety of Simeprevir with PegIFN/Ribavirin in Naïve or Experienced Patients Infected with Chronic HCV Genotype 4
Phase Phase III
ClinicalTrials.gov NCT01567735
Treatments
Simeprevir
Simeprevir
Tradename:OlysioOther Names:SMVClass:DiscontinuedFunding
IndustryJanssen
References
- Moreno C, Hezode C, Marcellin P, et al. Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4. J Hepatol. 2015;62:1047-55.
Editor's Summary
A PDF version of this treatment drug's summary, including the clinical trial descriptions and references.
Simeprevir Slide Deck
August 9, 2017
Clinical Trial Image Decks
ASPIRE - August 9, 2017
ATTAIN - August 9, 2017
PROMISE - August 9, 2017
QUEST-1 - August 9, 2017
QUEST-2 - August 9, 2017
RESTORE - August 9, 2017