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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.

o   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.