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- | Journal: Molecular Mechanisms of Resistance to Direct-Acting Antiviral (DAA) Drugs for the Treatment of Hepatitis C Virus Infections. (Pubmed Central) - Oct 14, 2023
The molecular phenomenon of DAA resistance is paramount in the development of HCV drug candidates. RAASs in NS3, NS5A, and NS5B reduce the susceptibility to DAAs; therefore, continuous RAAS-dependent resistance profiling in HCV is recommended to minimize the probability of DAA therapeutic failure.
- | faldaprevir (BI201335) / Boehringer Ingelheim
Journal: Interdisciplinary in silico studies to understand in-depth molecular level mechanism of drug resistance involving NS3-4A protease of HCV. (Pubmed Central) - Aug 24, 2022
The observations are also true in case of other Faldaprevir-like peptidomimetic inhibitors. Understanding this binding mechanism would be significant for the development of novel inhibitors with less susceptibility towards drug resistance.
- || faldaprevir (BI201335) / Boehringer Ingelheim
Clinical, PK/PD data, Journal: Effect of itraconazole on the pharmacokinetics of faldaprevir in healthy subjects. (Pubmed Central) - Jan 4, 2022
Co-administration with ICZ, however, resulted in an approximately two-fold increase in FDV steady-state exposure. Furthermore, FDV required no dosage adjustment when co-administered with ICZ.
- | Preclinical, Journal: Hepatitis C Virus Protease Inhibitors Show Differential Efficacy and Interactions with Remdesivir for Treatment of SARS-CoV-2 in Vitro. (Pubmed Central) - Aug 25, 2021
Acyclic PIs asunaprevir and faldaprevir had ECs of 72 and 23 μM, respectively...Viral suppression was achieved with 3- to 8-fold EC50 boceprevir or 1-fold EC50 simeprevir or grazoprevir, but not boceprevir, in combination with 0.4- to 0.8-fold EC50 remdesivir; these concentrations did not lead to viral suppression in single treatments. This study could inform development and application of protease inhibitors for optimized antiviral treatments of COVID-19.
- | faldaprevir (BI201335) / Boehringer Ingelheim, ASC-09 / J&J, Invirase (saquinavir) / Roche
Journal: Rational approach toward COVID-19 main protease inhibitors via molecular docking, molecular dynamics simulation and free energy calculation. (Pubmed Central) - Oct 30, 2020
Among them, saquinavir and three other investigational drugs aclarubicin, TMC-310911, and faldaprevir could be suggested as potential 3CL inhibitors. We recommend further experimental investigation of these compounds.
- |||| faldaprevir (BI201335) / Boehringer Ingelheim
Preclinical: #Researchers, the excellent preclinical properties of our HCV protease inhibitor faldaprevir make it an excellent choice for advancing science against #InfectiousDiseases. Now on #opnMe (Twitter) - Jun 8, 2020
- | TD-6450 / Innoviva, Trek Therapeutics
Trial completion, Combination therapy: A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection (clinicaltrials.gov) - Oct 16, 2017
P2, N=25, Completed, Sponsor: Trek Therapeutics, PBC
We recommend further experimental investigation of these compounds. Active, not recruiting --> Completed
- | faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Journal: Resistance Analyses of HCV NS3/4A Protease and NS5B Polymerase from Clinical Studies of Deleobuvir and Faldaprevir. (Pubmed Central) - Aug 5, 2017
Faldaprevir and deleobuvir RAVs are more prevalent among virologic failures than at baseline. Treatment response was not compromised by common NS3 polymorphisms; however, alanine at NS5B amino acid 499 at baseline (wild-type in GT-1a, polymorphism in GT-1b) may reduce response to this deleobuvir-based regimen.
- | TD-6450 / Innoviva, Trek Therapeutics
Enrollment closed, Combination therapy: A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection (clinicaltrials.gov) - Jan 30, 2017
P2, N=25, Active, not recruiting, Sponsor: Trek Therapeutics, PBC
Treatment response was not compromised by common NS3 polymorphisms; however, alanine at NS5B amino acid 499 at baseline (wild-type in GT-1a, polymorphism in GT-1b) may reduce response to this deleobuvir-based regimen. Recruiting --> Active, not recruiting
- | TD-6450 / Innoviva, Trek Therapeutics
Trial completion, Phase classification, Combination therapy: A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection (clinicaltrials.gov) - Jan 30, 2017
P2a, N=16, Completed, Sponsor: Trek Therapeutics, PBC
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Phase classification: P2 --> P2a
- | TD-6450 / Innoviva, Trek Therapeutics
Enrollment change, Combination therapy: A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection (clinicaltrials.gov) - Jul 29, 2016
P2, N=25, Recruiting, Sponsor: Trek Therapeutics, PBC
Active, not recruiting --> Completed | Phase classification: P2 --> P2a N=15 --> 25
- | TD-6450 / Innoviva, Trek Therapeutics
Enrollment open, Combination therapy: A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection (clinicaltrials.gov) - May 2, 2016
P2, N=15, Recruiting, Sponsor: Trek Therapeutics, PBC
N=15 --> 25 Not yet recruiting --> Recruiting
- | TD-6450 / Innoviva, Trek Therapeutics
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy: A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection (clinicaltrials.gov) - Apr 28, 2016
P2, N=16, Active, not recruiting, Sponsor: Trek Therapeutics, PBC
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=24 --> 16 | Trial primary completion date: Jul 2016 --> Nov 2016
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial termination: Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients (clinicaltrials.gov) - Apr 11, 2016
P1, N=4, Terminated, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting | N=24 --> 16 | Trial primary completion date: Jul 2016 --> Nov 2016 Completed --> Terminated
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial termination: Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel (clinicaltrials.gov) - Apr 11, 2016
P1, N=18, Terminated, Sponsor: Boehringer Ingelheim
Completed --> Terminated Completed --> Terminated
- | TD-6450 / Innoviva, Trek Therapeutics
New P2 trial, Combination therapy: A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection (clinicaltrials.gov) - Mar 23, 2016
P2, N=15, Not yet recruiting, Sponsor: Trek Therapeutics, PBC
- |||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial primary completion date, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Feb 12, 2016
P3, N=496, Completed, Sponsor: Boehringer Ingelheim
Completed --> Terminated Trial primary completion date: Jan 2015 --> Feb 2014
- TD-6450 / Innoviva, Trek Therapeutics
New P2 trial, Combination therapy: A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection (clinicaltrials.gov) - Oct 30, 2015
P2, N=24, Recruiting, Sponsor: Trek Therapeutics, PBC
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim
Trial completion, Combination therapy: Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4) (clinicaltrials.gov) - Sep 4, 2015
P3, N=310, Completed, Sponsor: Boehringer Ingelheim
Trial primary completion date: Jan 2015 --> Feb 2014 Active, not recruiting --> Completed
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Trial primary completion date, Combination therapy: IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 (clinicaltrials.gov) - Feb 23, 2015
P3, N=470, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Trial primary completion date, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Feb 23, 2015
P3, N=496, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015 Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015
- | Asclevir (ravidasvir) / Presidio Pharma, Ascletis, Pharco Pharmaceuticals
Trial completion, Combination therapy: Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C (clinicaltrials.gov) - Jan 22, 2015
P2, N=38, Completed, Sponsor: Presidio Pharmaceuticals, Inc.
Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015 Active, not recruiting --> Completed
- |||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Combination therapy: Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (clinicaltrials.gov) - Nov 18, 2014
P2, N=489, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Trial primary completion date, Combination therapy: Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients (clinicaltrials.gov) - Nov 6, 2014
P1, N=72, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Dec 2013 --> Oct 2014
- | faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Combination therapy: BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 (clinicaltrials.gov) - Oct 31, 2014
P2b, N=35, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed | Trial primary completion date: Dec 2013 --> Oct 2014 Active, not recruiting --> Completed
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Phase classification, Combination therapy: BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 (clinicaltrials.gov) - Jul 12, 2014
P2b, N=35, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Phase classification: P3 --> P2b
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim
Trial completion, Combination therapy: A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients (clinicaltrials.gov) - Jul 12, 2014
P3, N=119, Completed, Sponsor: Boehringer Ingelheim
Phase classification: P3 --> P2b Active, not recruiting --> Completed
- | faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects (clinicaltrials.gov) - Jul 8, 2014
P1, N=50, Completed, Sponsor: Boehringer Ingelheim
- | faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Bioavailability of Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Solution Formulation in Healthy Volunteers (clinicaltrials.gov) - Jul 8, 2014
P1, N=34, Completed, Sponsor: Boehringer Ingelheim
- | faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Effect of BI 201335 Mediated UGT1A1 (Uridine-diphosphate-glucuronosyltransferases) Inhibition in Healthy Volunteers (clinicaltrials.gov) - Jul 8, 2014
P1, N=24, Completed, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Single Rising Dose Study of BI 201335 ZW in Healthy Male Subjects (clinicaltrials.gov) - Jul 8, 2014
P1, N=8, Terminated, Sponsor: Boehringer Ingelheim
- | faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 201335 NA in Healthy Male Subjects (clinicaltrials.gov) - Jul 8, 2014
P1, N=39, Completed, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Metabolism and Pharmacokinetics of Oral Solution of [14C]-BI 201335 in Healthy Male Volunteers (clinicaltrials.gov) - Jul 8, 2014
P1, N=8, Completed, Sponsor: Boehringer Ingelheim
- | faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers (clinicaltrials.gov) - Jul 8, 2014
P1, N=23, Completed, Sponsor: Boehringer Ingelheim
- ||| faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects (clinicaltrials.gov) - Jul 8, 2014
P1, N=74, Completed, Sponsor: Boehringer Ingelheim
- ||| faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects (clinicaltrials.gov) - Jul 8, 2014
P1, N=56, Completed, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA in Healthy Male Volunteers (clinicaltrials.gov) - Jul 8, 2014
P1, N=37, Terminated, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim
Trial withdrawal: A Study to Investigate the Phototoxic Potential of Faldaprevir (clinicaltrials.gov) - Jun 27, 2014
P1, N=0, Withdrawn, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Withdrawn
- faldaprevir (BI201335) / Boehringer Ingelheim
Enrollment change, Trial withdrawal: A Study to Investigate the Phototoxic Potential of Faldaprevir (clinicaltrials.gov) - Jun 27, 2014
P1, N=0, Withdrawn, Sponsor: Boehringer Ingelheim
Recruiting --> Withdrawn N=60 --> 0 | Recruiting --> Withdrawn
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion date, Combination therapy: IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 (clinicaltrials.gov) - May 27, 2014
P3, N=475, Active, not recruiting, Sponsor: Boehringer Ingelheim
N=60 --> 0 | Recruiting --> Withdrawn Trial completion date: Oct 2015 --> Oct 2014
- |||| faldaprevir (BI201335) / Boehringer Ingelheim
Trial primary completion date, Combination therapy: Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3) (clinicaltrials.gov) - May 18, 2014
P3, N=678, Completed, Sponsor: Boehringer Ingelheim
Trial completion date: Oct 2015 --> Oct 2014 Trial primary completion date: Feb 2013 --> May 2014
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim
Trial completion, Combination therapy: Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3) (clinicaltrials.gov) - May 18, 2014
P3, N=678, Completed, Sponsor: Boehringer Ingelheim
Trial primary completion date: Feb 2013 --> May 2014 Active, not recruiting --> Completed
- | faldaprevir (BI201335) / Boehringer Ingelheim
Trial completion: Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus (clinicaltrials.gov) - May 18, 2014
P1, N=32, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion date, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Apr 29, 2014
P3, N=498, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Trial completion date: Sep 2015 --> Dec 2014
- ||| faldaprevir (BI201335) / Boehringer Ingelheim
Enrollment open: A Study to Investigate the Phototoxic Potential of Faldaprevir (clinicaltrials.gov) - Apr 29, 2014
P1, N=60, Recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Sep 2015 --> Dec 2014 Not yet recruiting --> Recruiting
- faldaprevir (BI201335) / Boehringer Ingelheim
Enrollment closed: Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus (clinicaltrials.gov) - Apr 29, 2014
P1, N=32, Active, not recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim
Trial completion, Combination therapy: Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-na (clinicaltrials.gov) - Apr 15, 2014
P3, N=659, Completed, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||| faldaprevir (BI201335) / Boehringer Ingelheim
New P1 trial: A Study to Investigate the Phototoxic Potential of Faldaprevir (clinicaltrials.gov) - Apr 13, 2014
P1, N=60, Recruiting, Sponsor: Boehringer Ingelheim
- || faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment change, Combination therapy: Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients (clinicaltrials.gov) - Mar 18, 2014
P1, N=72, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed N=102 --> 72
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim
Trial completion, Combination therapy: Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-na (clinicaltrials.gov) - Mar 16, 2014
P3, N=656, Completed, Sponsor: Boehringer Ingelheim
N=102 --> 72 Active, not recruiting --> Completed