Clinical Trials: New treatments for hepatitis C that
have been conducted in humans (phase I, II, III,
IV).
●
General
o
225. Safety, Tolerability, Pharmacokinetics
and Antiviral Activity following Single- and Multiple-Dose Administration of
BMS-650032, a Novel HCV NS3 Inhibitor, in Subjects with Chronic Genotype 1 HCV
Infection.
o
228. Phase I clinical trial with a
novel HCV therapeutic vaccine TG4040: Interim results of biomarker and
immunomonitoring analyzes.
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LB3. SILEN-C1: Early antiviral activity
and safety of BI 201335 combined with peginterferon alfa-2a and ribavirin in
treatment-naive patients with chronic genotype 1 HCV infection.
o
LB6. Treatment-naive, HCV genotype
1-infected subjects show significantly greater HCV RNA decreases when treated
with 28 days of ABT-333 plus peginterferon and ribavirin compared to
peginterferon and ribavirin alone. (updated Nov
6, 2009)
o
LB14. Hepatitis C virus (HCV) antibody
seroconversion in a U.S. HIV-infected male clinical trials population (updated Nov 13, 2009)
o
LB15. GI-5005 Therapeutic Vaccine Plus
Peg-IFN/Ribavirin Improves End of Treatment Response at 48 Weeks Versus
Peg-IFN/Ribavirin in Naive Genotype 1 Chronic HCV Patients.
o
63. Early Viral Response (EVR) Rates
in Treatment-naive Patients with Chronic Hepatitis C (CHC) Genotype 1 Infection
Treated with MK-7009, a Novel NS3/4a Protease Inhibitor, in Combination with
Pegylated Interferon Alfa-2a and Ribavirin for 28 Days (updated Nov 6, 2009)
o
65. Sustained Virologic Response (SVR)
Results for Weight-Based-Taribavirin Versus Weight-Based-Ribavirin, in Naive
Chronic-Hepatitis C, Genotype 1 Patients.
o
1568. Safety and Antiviral Activity
of NS5B Polymerase Inhibitor MK-3281, in Treatment-Naive Genotype 1A, 1B AND 3
HCV-Infected Patients. (updated Nov
6, 2009)
o
1576. Accelerated clinical trial
design to assess the safety, tolerability and anti-viral activity of PHX1766, a
novel HCV NS3/4A protease inhibitor, in healthy volunteers and chronic
hepatitis C patients. (updated Nov
6, 2009)
o
1583. IPH1101 first generation
γδ T cell agonist. Ex vivo and in vivo antiviral functions of
γδ T cells from chronically infected HCV patients treated in Phase 2
study.
o
Albuferon
§ 64.
Efficacy and Safety of albinterferon alfa-2b in Combination with ribavirin in
Treatment Naive Patients with chronic hepatitis C genotype 1.
§ 870.
Comparative Safety, Tolerability, Viral and Pharmacodynamic Efficacy of
Pegylated-interferons and albinterferon alfa-2b in HIV/HCV Genotype-1 Infected Patients.
§ 1567.
Efficacy and Safety Results of albinterferon alfa-2b in Combination with
ribavirin in Treatment Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.
(updated Nov 9, 2009)
§ 1572.
Similar Rates of Interstitial Findings on Chest X-ray in HCV Patients Treated
with albinterferon alfa-2b or peginterferon alfa-2a.
o
Alinia (Nitazoxanide - NTZ)
§ 904.
Effects of High Dose Ribavirin (RBV), Alinia (Nitazoxanide) and Pegylated
Interferon (PEG) alfa-2a in Attaining Sustained Viral Response (SVR) in
Treatment of Chronic Hepatitis C (ERAIS-C trial) - Interim Results in Naive
Genotype 1 Patients. (updated Nov
9, 2009)
§ 1580.
Pilot Study of Lead-In Nitazoxanide plus Pegylated Alpha-2a Interferon and
Ribavirin in HCV-Genotype 1 Nonresponders with Cirrhosis: Interim Results. (updated Nov 9, 2009)
§ 1588.
Controlled Release Nitazoxanide in Combination with Peginterferon alfa-2a plus
Ribavirin Results in High Early Virologic Response Rates for Treatment of
Chronic Hepatitis C Genotype 4. (updated Nov
10, 2009)
o
ANA773
§ 1560.
ANA773, an Oral Inducer of Endogenous Interferons that Acts Via TLR7, Reduced
Serum Viral Load in Patients Chronically Infected with HCV. (updated Nov 5, 2009)
o
BI 207127
§ 1599. BI
207127 is a potent HCV RNA polymerase inhibitor during 5 days monotherapy in
patients with chronic hepatitis C (updated Nov
4, 2009)
o
Boceprevir (SCH
503034)
§ 62. High
Sustained Virologic Response (SVR) in Genotype 1 (G1) Null Responders to
Peg-Interfeon alfa-2b (P) plus Ribavirin (R) When Treated with Boceprevir (Boc)
Combination Therapy. (updated Nov
4, 2009)
§ 1555.
SVR Results in Chronic Hepatitis C Genotype 1 Patients Dosed with SCH 900518
and Peginterferon Alfa-2b for 2 Weeks, Followed by Peginterferon Alfa-2b and
Ribavirin for 24/48 Weeks: An Interim Analysis.
§ 1582.
Response-Guided Therapy (RGT) for Boceprevir (Boc) Combination Treatment? Results from HCV SPRINT-1. (updated Nov 10, 2009)
o
ITMN-191 (R7227)
§ 1585.
Combination therapy with nucleoside polymerase R7128 and protease
R7227/ITMN-191 inhibitors in genotype 1 HCV infected patients: interim
resistance analysis of INFORM-1 cohorts A-D (updated Nov 4, 2009)
§ 1594.
Pharmacokinetics/Pharmacodynamics (PK/PD) of Combination R7227 and R7128
Therapy From INFORM-1 Demonstrates Similar Early HCV Viral Dynamics When R7227
is Combined With Either PEG-IFN/Ribavirin (SOC) or R7128
o
Narlaprevir (SCH
900518)
§ LB4. Once
Daily Narlaprevir (SCH 900518) in Combination with PEGINTRON (Peginterferon
alfa-2b)/Ribavirin for Treatment-Naive Subjects with Genotype-1 CHC: Interim
Results from NEXT-1, a Phase 2a Study. (updated Nov 4, 2009)
o
PEG-Interferon (IFN) Lambda
§ 1591. A
Phase 1b Dose-Ranging Study of 4 Weeks of PEG-Interferon (IFN) Lambda
(PEG-rIL-29) in Combination with Ribavirin (RBV) in Patients with Chronic
Genotype 1 Hepatitis C Virus (HCV) Infection. (updated Nov 10, 2009)
o
Pioglitazone
§
1571. Virologic and Metabolic
Responses in Chronic Hepatitis C (CHC) Patients with Insulin Resistance (IR)
Treated with Pioglitazone and Peginterferon Alfa-2a Plus Ribavirin.
o
R7128
§ 1585.
Combination therapy with nucleoside polymerase R7128 and protease
R7227/ITMN-191 inhibitors in genotype 1 HCV infected patients: interim
resistance analysis of INFORM-1 cohorts A-D (updated Nov 4, 2009)
§ 1594.
Pharmacokinetics/Pharmacodynamics (PK/PD) of Combination R7227 and R7128
Therapy From INFORM-1 Demonstrates Similar Early HCV Viral Dynamics When R7227
is Combined With Either PEG-IFN/Ribavirin (SOC) or R7128
o
Silibinin
§ 226.
Silibinin and Related Compounds are Direct Inhibitors of Hepatitis C Virus
RNA-Dependent RNA Polymerase.
§ 847.
Silibinin for treatment of nonresponders to peginterferon/ribavirin search for the optimal dosing schedule.
o
Telaprevir (VX-950)
§ 66. PROVE3
Final Results and 1-Year Durability of SVR with Telaprevir-Based Regimen in
Hepatitis C Genotype 1-Infected Patients with Prior Non-response, Viral
Breakthrough or Relapse to Peginterferon-Alfa-2a/b and Ribavirin Therapy. (updated Nov 10, 2009)
§ 793.
Dynamic response of innate immunity induced by telaprevir and PEG-IFN/RBV
treatment and its association with virological response and HCV variants.
§ 1565.
Telaprevir, Peginterferon Alfa-2a and Ribavirin Improved Rates of Sustained
Virologic Response (SVR) in “Difficult-to-Cure” Patients with Chronic Hepatitis
C (CHC): a Pooled Analysis From the PROVE1 and PROVE2 Trials. (updated Nov 11, 2009)
o
TMC435
§ 1563.
Antiviral activity and safety of TMC435 combined with pegylated interferon and
ribavirin in hepatitis C patients with genotype-1 who had previous exposure to
TMC435. (updated
Nov 4, 2009)
o
Thymosin alpha
§ 1564.
Thymosin alfa-1 (Tα1) in association with Peg-IFN alfa-2a and Ribavirin
(RBV) for retreatment of chronic hepatitis C (CHC) patients non-responders to
Peg-IFNs and RBV.Phase III multicenter European study.
● Vaccines
o
1558. Significant continuous viral
load decline in treatment-naive HCV genotype 1 patients after therapeutic
peptide vaccination with IC41.