Publications & Presentations

Below is a listing of scientific publications and presentations related to Idenix hepatitis C drug candidates.

IDX719 Program

 Cyril B. Dousson; ICAR 2013, 5.12.2013
"Next generation HCV NS5A inhibitor: In vitro antiviral optimization for pan-genotypic activity and preclinical profile"

 McCarville et al; EASL 2013, 4.27.13
"Treatment-Emergent Variants Following 3 Days Of Monotherapy With IDX719, A Potent, Pan-Genotypic NS5A Inhibitor, In Subjects Infected With HCV Genotypes 1-4"

 Zhou et al; AASLD 2012, 11.13.12
"IDX719, HCV NS5A Inhibitor, Demonstrates Pan-Genotypic Activity after Three Days of Monotherapy in Genotype 1, 2, 3 or 4 HCV-Infected Subjects"

 Mayers et al; EASL-AASLD Special Conference on Therapy of Hepatitis C: Clinical Application and Drug Development, September 14 – 16, 2012
"Safety, Pharmacokinetic and Antiviral Activity Results from a First-in-Human Study of IDX719, A Pan-Genotypic HCV NS5A Inhibitor"

 Bilello et al; 7th International Workshop on Hepatitis C — Resistance and New Compounds, 6.29.12
"The preclinical profile of the pan-genotypic HCV NS5A inhibitor IDX719 demonstrates its potential for combination therapy"

 Zhou et al; 7th International Workshop on Clinical Pharmacology of Hepatitis Therapy, 6.27.12
"Safety, Pharmacokinetic and Preliminary Antiviral Activity Results from a First-in-Human Study of IDX719, a Pan-Genotypic Novel HCV NS5A Inhibitor"

 Zhou et al; CHI 2012, 4.18.12
"Combination DAA Strategies to Cure HCV"

 Bilello et al, HCV 2011, 9.8.11
"Antiviral and Preclinical Profiles of HCV NS5A Inhibitors IDX380 and IDX719"

 McCarville et al, EASL 2011, 4.1.11
"Idenix NS5A HCV replication inhibitors with low picomolar, pan-genotypic in vitro antiviral activity"

 

IDX184, HCV nucleotide polymerase inhibitor^*

 Mayers et al; AASLD 2012, 11.13.12
"High Rates of Rapid Virologic Response (RVR) and Complete Early Virologic Response (cEVR) with IDX184, Pegylated Interferon and Ribavirin in Genotype 1 HCV-Infected Subjects: Interim Results"

 Standring et al; 20th International Round Table on Nucleosides, Nucleotides and Nucleic Acids, 8.8.12
"IDX184 and Novel Nucleotides for the Treatment of HCV"

 McCarville et al, EASL 2011, 4.2.11
"No resistance to IDX184 was detected in 3-day and 14-day clinical studies of IDX184 in genotype 1-infected HCV subjects"

 IDX184 Phase 1 AAC Paper 2011
"Safety and Pharmacokinetics of IDX184, a Liver-Targeted Nucleotide Polymerase Inhibitor of Hepatitis C Virus, in Healthy Subjects"

 Lalezari et al, AASLD 2010, 10.31.10
"A Phase IIa Study of IDX184 in Combination with Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Treatment-Naïve Genotype 1 HCV-Infected Subjects"

 McCarville et al; 6.25.10
"In Vitro and In Vivo Resistance Profile of IDX184, a Novel Nucleotide Analog for the Treatment of HCV Infection"
5th International Workshop on Hepatitis C-Resistance and New Compounds - June 24-25, 2010

 Lalezari et al, EASL 2010, 4.15.10
"Antiviral Activity, Pharmacokinetics and Safety of IDX184 in Combination with Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Treatment-Naive HCV Genotype 1-infected Subjects”

 Lalezari et al, AASLD 2009, 11.2.09
"Antiviral Activity, Safety and Pharmacokinetics of IDX184, a Liver-Targeted Nucleotide HCV Polymerase Inhibitor, in Patients with Chronic Hepatitis C”

 Lallos et al, AASLD 2009, 11.3.09
"Combination of IDX184, a Nucleotide Prodrug Polymerase Inhibitor, with Other Classes of HCV Inhibitors is Additive to Synergistic in the HCV Replicon in vitro”

 Standring et al, EASL 2009, 4.24.09
“Antiviral Activity of the Liver-Targeted Nucleotide HCV Polymerase Inhibitor IDX184 Correlates with Trough Serum Levels of the Nucleoside Metabolite in HCV-Infected Chimpanzees”

 Zhou et al, EASL 2009, 4.25.09
“IDX184, A Liver-Targeted Nucleotide HCV Polymerase Inhibitor: Results of a First-in-Man Safety and Pharmacokinetic Study”

* In August 2012, IDX184 was placed on partial clinical hold by the FDA.

Click to view partial clinical hold press release

 

IDX19368^** and Nucleoside Program

 Standring et al; 19th International Symposium on Hepatitis C Virus and Related Viruses; Venice, Italy; 10.7.12
"The Pharmacological Properties of IDX19368, a Novel Nucleotide Prodrug, Highlight its Potential For Use in a Low-Dose DAA Regimen for HCV"

 Dousson et al; 20th International Round Table on Nucleosides, Nucleotides and Nucleic Acids, 8.9.12
"Potent HCV Diamidate Pronucleotide Inhibitors: In Vitro Antiviral Activity Optimization"

** In August 2012, IDX19368 was placed on clinical hold by the FDA.

Click to view clinical hold press release

 

HCV Combination Therapy

 Douglas et al, The 2^nd World Congress on Controversies in the Management of Viral Hepatitis (C-Hep), 10.18.12
"Combination DAA Therapy for Hepatitis C"

 Douglas Mayers, Victor De Gruttola 4.30.10
"Challenges in Designing Trials for Direct Acting Antiviral (DAA) Combination Therapy of HCV Infection”
FDA Public Hearing - April 30, 2010

 La Colla et al, EASL 2010, 4.16.10
"Triple Combinations of Direct-Acting Antiviral Agents Demonstrate Robust Anti-HCV Activity In Vitro”