Experimental Therapies:  New treatments for hepatitis C including pre-clinical development that have not yet been studied in humans, and various drugs that are in phase I, II and III development to treat hepatitis C.

 

·        Adjunct Therapies

o       Eltrombopag

§        1874. Population PK/PD modeling of eltrombopag concentration-platelet response and dose simulations for patients with chronic hepatitis C virus (HCV)-infection.

 

o       General

§        1858. A double blind, placebo-controlled trial with escitalopram to prevent psychiatric adverse events during treatment with pegylated interferon-alpha and ribavirin for chronic hepatitis C: The “Prevention Of Psychiatric Side effects (POPS)-study.”

 

·        Drug Resistance

o       994. Dynamical Archiving - a Novel Mechanism for Post-Treatment Long Term Persistence of Resistant HCV Strains to Direct Anti-viral Drugs.  

 

·        General

o       LB5. SAMe Improves Early Viral Kinetics and Interferon Stimulated Gene Induction When Added to Peginterferon and Ribavirin Therapy for Previous Hepatitis C Non-Responders.  

o       LB12. BMS-790052 is a First-in-class Potent Hepatitis C Virus (HCV) NS5A Inhibitor for Patients with Chronic HCV Infection: Results from a Proof-of-concept Study.

o       LB13. Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers.

o       170. Interim Results from a Phase 1b Dose-Escalation Study of 4 Weeks of PEG-Interferon Lambda (PEG-rIL-29) Treatment in Subjects with Hepatitis C Virus (HCV) Genotype 1 with Prior Virologic Response and Relapse to Peginterferon Alfa and Ribavirin.

o       510. Consistent Results For Antiviral Activity And Safety Of Sustained Release Interferon-Alpha-2b (IFN-Alpha-2b XL) Compared To Marketed IFN-Alpha-2b And Its Pegylated Form (Peg-IFN-Alpha-2b) In Two Phase I Trials In Hepatitis C (HCV) Patients.

o       1859. Double-blind, randomized, placebo-controlled, multi-center, Phase II dose-ranging study to assess the antifibrotic activity of farglitazar in chronic hepatitis C infection.

o       1863. Intravenous silibinin for treatment of nonresponders to peginterferon/ribavirin therapy in chronic hepatitis C.  

o       1870. Viral Kinetic Response to 12 Week Treatment with Rosiglitazone in Chronic Hepatitis C, Genotype 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin.  

o       1888. A Novel Sustained Release Interferon-Alpha-2b (IFN-Alpha-2bXL) With Optimized Pharmacokinetics/Pharmacodynamics Relationship vs. Pegylated Interferon-Alpha-2b (Peg-IFN-Alpha-2b): A Phase Ib Trial In HCV Patients. 

o       1890. Cyclosporine in HCV-non responders: a cytoprotective effect without antireplicative action. A phase II study.  

o       1891. In Chronic Hepatitis C (HCV), Pretreatment with Thiazolidinediones (TZDs) or Metformin Decreases Insulin Resistance (IR) and HCV Viral Load and Increases Early Virologic Response (EVR). 

o       1892. Niacin but not simvastatin is associated with reduced Hepatitis C RNA titers: A Cross-Sectional Analysis.

o       1897. Genotypic and phenotypic analysis of Hepatitis C Virus NS5B polymerase variants to BILB 1941 inhibition.   

o       1900. Effects of ACE-Inhibitors on Liver Fibrosis in HIV and Hepatitis C (HCV) Co-Infection. 

 

·        Clinical Trials – new treatments for hepatitis C that have been conducted in humans (phase I, II, III, IV)

 

o       BI201335

§        1882. Safety and antiviral activity of BI201335, a new HCV NS3 protease inhibitor, in combination therapy with Peginterferon alfa 2a (P) and Ribavirin (R) for 28 days in P+R treatment-experienced patients with chronic hepatitis C genotype-1 infection. 

§        1849. Safety and antiviral activity of BI201335, a new HCV NS3 protease inhibitor, in treatment-naive patients with chronic hepatitis C genotype-1 infection given as monotherapy and in combination with Peginterferon alfa 2a (P) and Ribavirin (R).

 

o       Boceprevir (SCH 503034)

§        LB16. HCV SPRINT-1: Boceprevir plus Peginterferon alfa-2b/Ribavirin for Treatment of Genotype 1 Chronic Hepatitis C in Previously Untreated Patients. (updated Nov 3, 2008)

 

o       ITMN-191 (R7227)

§        1847. Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Patients with the NS3/4A Protease Inhibitor ITMN-191 Leads to Rapid Reductions in Plasma HCV RNA: Results of a Phase 1b Multiple Ascending Dose (MAD) Study.

§        1861. Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships for ITMN-191 in a Phase 1 Multiple Ascending Dose Trial in Patients with Genotype 1 Chronic Hepatitis C (CHC)Infection. 

§        1871. A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics (PK) of Single Ascending Oral Doses of the NS3/4A Protease Inhibitor ITMN 191 in Healthy Subjects.  

§        1885. Combination of the NS3/4A Protease Inhibitor ITMN-191 (R7227) with the Active Moiety of the NS5B Inhibitors R1626 or R7128 Enhances Replicon Clearance and Reduces the Emergence of Drug Resistant Variants.

 

o       MK-7009

§        211. Safety, Tolerability and Antiviral Activity of MK-7009, a Novel Inhibitor of the Hepatitis C Virus NS3/4A Protease, in Patients with Chronic HCV Genotype 1 Infection.

§        1910. Safety, Tolerability, and Pharmacokinetic Data Following Single- and Multiple-Dose Administration of MK-7009, a Hepatitis C Virus Non-structural 3/4a Protease Inhibitor, to Healthy Male Subjects. 

 

o       Nitazoxanide (NTZ)

§        1000. Nitazoxanide Inhibits Hepatitis C Virus Replication In Vitro.  

§        1848. Evaluation of a 4 Week Lead-In Phase with Nitazoxanide (NTZ) Prior To Peginterferon (PegIFN) Plus NTZ for Treatment of Chronic Hepatitis C: Final Report.

§        1881. Nitazoxanide (NTZ) is an inducer eIF2a and PKR phosphorylation.

 

o       PF-0086554

§        LB11. Antiviral Activity of the HCV Polymerase Inhibitor PF-00868554 Administered as Monotherapy in HCV Genotype 1 Infected Subjects. (updated Nov 3, 2008)

§        1898. Safety, Tolerability and Pharmacokinetics of the HCV Polymerase Inhibitor PF-00868554 Following Multiple Dose Administration in Healthy Volunteers.  

 

o       Pioglitazone

§        167. Pioglitazone improves early virologic kinetic response to Peg IFN/RBV combination therapy in hepatitis C genotype 1 naïve patients.

 

o       R7128

§         LB10. Antiviral Activity Of The HCV Nucleoside Polymerase Inhibitor R7128 In HCV Genotype 2 And 3 Prior Non-Responders: Interim Results Of R7128 1500mg BID With PEG-IFN And Ribavirin For 28 Days. (updated Nov 3, 2008)

§        1885. Combination of the NS3/4A Protease Inhibitor ITMN-191 (R7227) with the Active Moiety of the NS5B Inhibitors R1626 or R7128 Enhances Replicon Clearance and Reduces the Emergence of Drug Resistant Variants.

§        1899. Potent Antiviral Response To The HCV Nucleoside Polymerase Inhibitor R7128 For 28 Days With Peg-Ifn And Ribavirin: Subanalysis by Race/Ethnicity, Weight and HCV Genotype.

 

o       Taribavirin

§         272. Treatment Week 24 Results of Weight-based Taribavirin Versus Weight-Based Ribavirin, Both with Peginterferon alfa-2b, in Naïve Chronic Hepatitis C, Genotype 1 Patients.

§         1857. Taribavirin Exposure Analysis from a Previous Phase 3 Trial Correlates with Phase 2b Weight Based Dosing Interim Results.

 

o       Telaprevir (VX-950)

§        269. A Phase 2b Study of Telaprevir with Peginterferon-Alfa-2a and Ribavirin in Hepatitis C Genotype 1 Null and Partial Responders and Relapsers Following a Prior Course of Peginterferon-Alfa-2a/b and Ribavirin Therapy: PROVE3 Interim Results.  

§        1011. Long term follow up of patients previously treated with telaprevir.  

§        1846. Viral Responses in African-Americans, Latinos and Caucasians in the US Phase 2 Study (PROVE1) of Telaprevir with Peginterferon Alfa-2a and Ribavirin in Treatment-Naïve Genotype 1-infected Subjects with Hepatitis C.

§        1852. A Study of Telaprevir Combined with Peginterferon-Alfa-2a and Ribavirin in Subjects with Well-Documented Non-Response or Relapse after Previous Peginterferon-Alfa-2a and Ribavirin Treatment: Interim Analysis.

§        1854. Phase 2 Study of Telaprevir Administered q8h or q12h with Peginterferon-Alfa-2a or -Alfa-2b and Ribavirin in Treatment-Naïve Subjects with Genotype 1 Hepatitis C: Week 4 Interim Results. (Updated Nov 4, 2008)

§        1856. No Compensatory Fitness Mutations Selected in NS3/4A Protease Cleavage Sites During Treatment with Telaprevir, Peg-IFN-Alfa-2a, and Ribavirin in Phase II Studies of Treatment-Naïve HCV Genotype 1-Infected Patients. 

§        1887. Characterization of a new amino acid substitution (V36C) associated with telaprevir (VX-950) resistance in a patient treated with telaprevir, peginterferon alpha-2a and ribavirin. 

 

o       TMC435350

§        LB8. Safety and antiviral activity of TMC435350 in treatment-naïve genotype 1 HCV-infected patients.

§        1895. Pharmacokinetics of once-daily regimens of the novel HCV NS3/4A-protease inhibitor TMC435350, with and without pegIFN and ribavirin, in HCV-infected individuals. 

 

·        Vaccines

o       LB7. Antiviral effects of therapeutic vaccination with naked DNA delivered by in vivo electroporation in patients with chronic hepatitis C.  

o       LB9. GI5005 Immunotherapy Plus Peg-IFN/Ribavirin In Genotype 1 Chronic Hepatitis C Patients Compared To Peg-IFN/Ribavirin Alone In Naive and Non-Responder Patients; Preliminary RVR and Viral Kinetic Analysis From the GI5005-02 Phase 2 Study.