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- | grazoprevir (MK-5172) / Merck (MSD), Sovaldi (sofosbuvir) / Gilead, elbasvir (MK-8742) / Merck (MSD)
Clinical, Journal: Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. (Pubmed Central) - Aug 9, 2019
P4
Recipients of kidneys from donors with genotype 1 infection continued receiving GZR-EBR for 12 weeks after transplantation; those receiving organs from donors with genotype 2 or 3 infection had sofosbuvir, 400 mg, added to GZR-EBR for 12 weeks of triple therapy...If confirmed in larger studies, this strategy should markedly expand organ options and reduce mortality for kidney transplant candidates without HCV infection. Merck Sharp & Dohme Corp.
- | elbasvir (MK-8742) / Merck (MSD)
Journal: The Discovery of MK-6169, A Potent Pan-genotype Hepatitis C Virus NS5A Inhibitor with Optimized Activity Against Common Resistance-Associated Substitutions. (Pubmed Central) - May 29, 2019
SAR studies around the combination of changes to both the valine and aminal carbon region of elbasvir lead to the discovery of a series of compounds with substantially improved potency against common resistance-associated substitutions in the major genotypes, as well as good pharmacokinetics in both rat and dog. Through further optimization of key leads from this effort, MK-6169 (21) was discovered as a pre-clinical candidate for further development.
- | elbasvir (MK-8742) / Merck (MSD)
Clinical, P3 data, Journal, HEOR: Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled trial. (Pubmed Central) - Sep 27, 2018
P2/3
Through further optimization of key leads from this effort, MK-6169 (21) was discovered as a pre-clinical candidate for further development. These data add to the growing body of clinical evidence for the fixed-dose combination regimen of elbasvir plus grazoprevir for 12 weeks and support use of this therapy in patients with HCV genotype 1 infection and stage 4-5 chronic kidney disease.
- | grazoprevir (MK-5172) / Merck (MSD)
PK/PD data, Journal: The Effect of Hepatic Impairment on the Pharmacokinetics of Grazoprevir, a Hepatitis C Virus Protease Inhibitor. (Pubmed Central) - Jul 22, 2018
No dose adjustment is required for GZR in people with HCV with mild HI. GZR is contraindicated in those with moderate or severe HI (Child-Pugh B or C), as they may have significantly increased GZR exposures that may lead to increased risk of transaminase elevations.
- || Trial primary completion date: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - Jun 2, 2017
P2, N=413, Completed, Sponsor: Merck Sharp & Dohme Corp.
GZR is contraindicated in those with moderate or severe HI (Child-Pugh B or C), as they may have significantly increased GZR exposures that may lead to increased risk of transaminase elevations. Trial primary completion date: Feb 2017 --> Sep 2016
- |||| Trial completion: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - May 8, 2017
P2, N=413, Completed, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Feb 2017 --> Sep 2016 Active, not recruiting --> Completed
- |||| Trial completion: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011) (clinicaltrials.gov) - Dec 19, 2016
P2, N=443, Completed, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| Enrollment open: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - Jun 29, 2016
P2, N=500, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Active, not recruiting --> Recruiting
- ||| Enrollment closed: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - Jun 20, 2016
P2, N=500, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- || Trial primary completion date: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - Mar 25, 2016
P2, N=500, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Trial primary completion date: Sep 2016 --> Jan 2017
- ||| Enrollment closed: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011) (clinicaltrials.gov) - Mar 18, 2016
P2, N=465, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Sep 2016 --> Jan 2017 Recruiting --> Active, not recruiting
- || Trial primary completion date: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011) (clinicaltrials.gov) - Oct 27, 2015
P2, N=465, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2015 --> Jul 2016
- ||| Enrollment change, Trial primary completion date: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - Oct 23, 2015
P2, N=460, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Dec 2015 --> Jul 2016 N=220 --> 460 | Trial primary completion date: Dec 2015 --> Jul 2016
- |||| Enrollment open, Trial primary completion date: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011) (clinicaltrials.gov) - Feb 10, 2015
P2, N=480, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=220 --> 460 | Trial primary completion date: Dec 2015 --> Jul 2016 Not yet recruiting --> Recruiting | Trial primary completion date: Sep 2015 --> Dec 2015
- |||| Enrollment open: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - Feb 9, 2015
P2, N=220, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting | Trial primary completion date: Sep 2015 --> Dec 2015 Not yet recruiting --> Recruiting
- ||||| New P2 trial: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012) (clinicaltrials.gov) - Jan 7, 2015
P2, N=220, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- ||||| New P2 trial: Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011) (clinicaltrials.gov) - Jan 7, 2015
P2, N=480, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | elbasvir (MK-8742) / Merck (MSD)
Trial completion: The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009) (clinicaltrials.gov) - Sep 4, 2014
P1, N=31, Completed, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- elbasvir (MK-8742) / Merck (MSD)
Enrollment closed: The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009) (clinicaltrials.gov) - Aug 29, 2014
P1, N=32, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- elbasvir (MK-8742) / Merck (MSD)
Enrollment open: The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009) (clinicaltrials.gov) - Jul 28, 2013
P1, N=32, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting
- elbasvir (MK-8742) / Merck (MSD)
Enrollment change: Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002) (clinicaltrials.gov) - May 27, 2013
P1, N=48, Completed, Sponsor: Merck
Active, not recruiting --> Recruiting N=60 --> 48
- elbasvir (MK-8742) / Merck (MSD)
Trial completion: Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002) (clinicaltrials.gov) - May 27, 2013
P1, N=48, Completed, Sponsor: Merck
N=60 --> 48 Active, not recruiting --> Completed
- | elbasvir (MK-8742) / Merck (MSD)
New P1 trial: The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009) (clinicaltrials.gov) - Feb 20, 2013
P1, N=32, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
- elbasvir (MK-8742) / Merck (MSD)
New P1 trial: Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002) (clinicaltrials.gov) - Feb 13, 2012
P1, N=48, Completed, Sponsor: Merck