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.

 

·        General

o       84. A pilot randomized controlled study evaluating efficacy of autologous bone marrow mononuclear cells transplantation in patients with advanced chronic liver disease

o       1307. PF-03491390 inhibits liver fibrosis in patients with chronic hepatitis C virus infection via suppression of pro-apoptotic caspase-activation. (updated November 19, 2007)

o       1313. Effect of Infliximab on the Efficacy of Peginterferon alfa-2b (PEG-2b) Plus Ribavirin (RBV) Therapy in Treatment-Naive Patients With Hepatitis C Genotype 1 and High Tumor Necrosis Factor α (TNF-α) Levels

o       1387. A Hepatitis C T-Cell Vaccine Candidate Covering HCV Genotype Complexity and HLA Type Diversity (updated November 9, 2007)

o       1389. Efficacy of Interferon β combined cyclosporine A treatment in the retreatment of chronic hepatitis C - Promising aspect of host factor targeting therapy. (updated November 9, 2007)

o       1396. Modeling the potential cost-effectiveness of adding a novel STAT-C agent to current standard therapy in patients with genotype 1 chronic hepatitis C infection.

o       1397. AM3 inhibits HCV replication through activation of peripheral blood mononuclear cells.

 

 

·        Preclinical trials – new treatment for hepatitis C that have not yet been tested in humans

 

o       ANA 598

§        1392. ANA598, a Novel Non-Nucleoside Inhibitor of HCV NS5B Polymerase, Exhibits Favorable Pharmacokinetic Properties in Multiple Preclinical Species (updated November 12, 2007)

 

o       ME 3738

§        1393. ME3738 inhibits hepatitis C virus replication by enhancing interferon-β

 

o       PF-00868554

§        1394. Preclinical Evaluations of PF-00868554, a Potent Non-nucleoside Inhibitor of the Hepatitis C Virus RNA Polymerase (updated November 12, 2007)

 

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

 

o       Bavituximab

§        53. Multiple dose safety and pharmacokinetic study of bavituximab in patients with chronic hepatitis C virus (HCV) infection

 

o       Boceprevir (SCH 503034)

§        1391. HCV Polymerase (NM107) and Protease (boceprevir) Inhibitors in Combination Show Enhanced Activity and Suppression of Resistance in the Replicon System

 

o       GI-5005

§        1304. HCV-Specific Cellular Immunity, RNA Reductions, and Normalization of ALT in Chronic HCV Subjects after Treatment with GI-5005, a Yeast-Based Immunotherapy Targeting NS3 and Core: A Randomized, Double-blind, Placebo Controlled Phase 1b Study (updated November 9,2007)

 

o       GS-9190

§        49. Antiviral, Pharmacokinetic and Safety Data for GS-9190, a Non-nucleoside HCV NS5b Polymerase Inhibitor, in a Phase-1 Trial in HCV Genotype 1 Infected Subjects

§        1385. GS-9190, a novel substituted imidazopyridine analogue, is a potent inhibitor of hepatitis C virus replication in vitro and remains active against known drug resistant mutants.

§        1395. Mechanistic Characterization of GS-9190, a Novel Non-nucleoside Inhibitor of HCV NS5B Polymerase with Potent Antiviral Activity and a Unique Mechanism of Action

§        1398. Preclinical Pharmacokinetic Characterization of GS-9190, a Novel Non-nucleoside HCV NS5B Polymerase Inhibitor.

 

o       HCV 796

§        1302. Phase 1 evaluation of antiviral activity of the non-nucleoside polymerase inhibitor, HCV-796, in combination with different pegylated interferons in treatment-naive patients with chronic HCV

 

o       ITMN-191 (R7227)

§        1386. Genotype Coverage of the HCV NS3/4A Protease Inhibitor ITMN-191 (R7227): Biochemical Data Reveals Potent Inhibition and Slow Dissociation with Genotype 1-6 Proteases

 

o       Locteron

§        LB10. Phase 2a study to evaluate the safety and tolerability and anti-viral of 4 doses of a novel, controlled-release interferon-alfa 2b (Locteron) given every 2 weeks for 12 weeks in treatment-naive patients with chronic hepatitis C (genotype 1)

 

o       NTZ

§        178. Interim Data from a Randomized Controlled Trial of Nitazoxanide-Peginterferon-Ribavirin, Nitazoxanide-Peginterferon and Peginterferon-Ribavirin in the Treatment of Patients with Chronic Hepatitis C Genotype 4

 

o       R1626

§        167. Robust Synergistic Antiviral Effect of R1626 in Combination with Peginterferon alfa-2a (40KD), with or without Ribavirin – Interim Analysis Results of Phase 2a Study

§        1298. A high barrier to resistance may contribute to the robust antiviral effect demonstrated by R1626 in HCV genotype 1-infected treatment-naive patients R7025 (updated November 19,2007)

 

o       R7025

§        1377. A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Escalating Single Doses of R7025, a Novel Pegylated Interferon α Compared to Placebo and Peginterferon α 2a (40KD) (PEGASYS®) in Healthy Volunteers (updated November 9,2007)

 

o       R7128

§        LB9. Antiviral Activity, Pharmacokinetics, Safety, and Tolerability of R7128, a Novel Nucleoside HCV RNA Polymerase Inhibitor, Following Multiple, Ascending, Oral Doses in Patients with HCV Genotype 1 Infection Who have Failed Prior Interferon Therapy (updated November 12,2007)

 

o       Telaprevir (VX-950)

§        50. Telaprevir resistance mutations in patients with hepatitis C who relapsed after sequential therapy with telaprevir, peg-interferon alfa 2a and ribavirin

§        80. PROVE2: Phase II Study of VX950 (TELAPREVIR) in Combination with Peginterferon ALFA2A With or Without Ribavirin in Subjects With Chronic Hepatitis C, First Interim Analysis

§        175. Final Results of Patients Treated with Peg-Interferon-Alfa-2a (Peg-IFN) and Ribavirin (RBV) Follow-on Therapy After 28-Day Treatment with the Hepatitis C Protease Inhibitor Telaprevir (VX-950), Peg-IFN and RBV

§        177. Interim Analysis Results from a Phase 2 Study of Telaprevir with Peginterferon alfa-2A and Ribavirin in Treatment-naïve Subjects with Hepatitis C

 

o       Thymosin

§        1331. Retreatment of treatment experienced HCV patients with pegylated interferon alfa-2a and thymosin alpha-1: Pooled analysis of two randomized controlled trials (updated November 9, 2007)

 

o       TMC435350

§        1318. Results Of A Phase I Placebo-Controlled Trial In Healthy Volunteers To Examine The Safety, Tolerability And Pharmacokinetics Of The HCV Protease Inhibitor TMC435350 After Single And Repeated Dosing (updated November 12, 2007)

§        1390. In Vitro Activity And Preclinical Pharmacokinetics Of The HCV Protease Inhibitor, TMC435350.

 

o       VCH-759

§        LB11. Antiviral activity of the non-nucleoside polymerase inhibitor, VCH-759, in chronic Hepatitis C patients:Results from a randomized, double-blind, placebo -controlled, ascending multiple dose study. (updated November 12, 2007)