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.