Miscellaneous Studies

General

· LB-14. Adverse Event Reporting During HCV Treatment Via Weekly Clinic Visits Substantially Underestimates Flu Frequency & Severity Compared To Daily ePRO: Results From 133 Patients In EMPOWER

· 35. Cell-to-cell transmission of small silencing RNA in the liver extends the therapeutic reach of RNAi.

· 228. Clinical, Virological, Biochemical Outcomes After 20 Years of Sustained Virological Response (SVR) in Chronic Hepatitis C: The NIH Experience.

· 811. Ex vivo induction and expansion of HCV core antigen-specific cytotoxic T cells by HLA-Ig-coated artificial antigen-presenting cells.

· 829. Clinical efficiency of the HCV NS3 Protease N-terminal 181 amino acid region on a large panel of clinical trial isolates using a subtype-specific genotyping assay.

· 1886. Altered hepatic energy metabolism and a lack of obvious adverse findings after miR-122 inhibition in mice.

GS 5885

Pre-conference summary: NS5A Inhibitor—no data is available.

· 1883. Nonclinical Profile and Phase I Results in Healthy Volunteers for the Novel and Potent HCV NS5A Inhibitor GS-5885

GS 9451

Pre-conference summary: Caspase Inhibitor—no data is available.

· 820. Three-Day, Dose-Ranging Study of the HCV NS3 Protease Inhibitor GS-9451. 

IL28B Genotype

· LB-13. Non response to peginterferon alfa and ribavirin in IL28B CC & CT patients can be overcome by high dose continuous interferon alfa-2b administration in combination with ribavirin for chronic hepatitis C. 

· 129. The IL28B genotype is a major determinant in the induction of a virological response by high-dose peginterferon and ribavirin in null-responders to standard-of-care therapy.

· 130. Completely individualized treatment durations with peginterferon-alfa-2b and ribavirin in HCV genotype 1-infected patients and importance of IL28B genotype (INDIV-2 study). 

· 798. Predictive value of IL-28 polymorphism of effect of interferon therapy in patients with genotype 2a and 2b chronic hepatitis C. 

· 810. Hepatitis C trials that combine investigational agents with pegylated-interferon-α should be stratified by IL28B genotype.

· 815. IL28B SNP Geographical Distribution and Antiviral Responses in a 28-day Phase 2a Trial of PSI-7977 Daily Dosing plus PEG-IFN/RBV. 

· 836. Selecting the right IL28 SNPs – analysis of the IL28A/IL28B inverted gene duplication.

· 1852. IL28B Polymorphism and Kinetics of Antiviral Activity for ANA598 in Combination With Pegylated Interferon α2A Plus Ribavirin in Treatment-Naïve Genotype-1 Chronic HCV Patients.

· 1879. IL28B rs12979860 SNP is associated with lipids metabolism, viral genotype and spontaneous viral clearance in Hepatitis C.

Insulin Resistance

· 808. Virologic and Metabolic Responses in Chronic Hepatitis C (CHC) Genotype 1 (G1) Patients With Insulin Resistance (IR) Treated With Pioglitazone (PIO) and Peginterferon alfa-2a Plus Ribavirin (P/R) – Final Results of Week 12 Early Virologic Response. 

· 1857. Insulin resistance and obesity is improved by aerobic exercise that can be safely performed even by patients with hepatitis C virus.

Nitazoxanide

Pre-conference summary: Thiazolides—Phase II study found that the combination of nitazoxanide plus pegylated interferon plus ribavirin to treat HCV genotype 1 treatment naïve patients increased the SVR rates to 44% compared to 32% in the group who received pegylated interferon plus ribavirin, did not receive nitazoxanide.

· 1877. HCV resistance To Nitazoxanide is not due to Changes in the Viral Sequence

· 1878. Augmentation of Interferon signaling pathway by Nitazoxanide: A novel therapeutic strategy for Relapsers to Peg-interferon and Ribavirin therapy.

Silibinin

Pre-conference summary: The active ingredient in milk thistle that is believe to help improve liver health.

· 835. Undetectable HCV RNA after Silibinin iv treatment is associated with high on treatment response rates in HCV nullresponders. 

· 1870. Differential in vitro Effects of Intravenous Versus Oral Formulations of Silibinin on the HCV Life Cycle and Inflammation

SCY-635

Pre-conference summary: Cyclophilin Inhibitor—Phase I studies have demonstrated a clinically relevant reduction in HCV RNA.

· 36. The Non-Immunosuppressive Cyclophilin Inhibitor SCY-635 Inhibits the Association of NS5A and Cyclophilin A.

Vitamin D

Pre-conference summary: Vitamin D has been shown to inhibit the replication of the hepatitis C virus and possibly increase the chances of treatment response.

· 803. Vitamin D Metabolites Inhibit Replication of the Hepatitis C Virus.

· 809. Vitamin D supplementation improves viral response in chronic hepatitis C genotype 2/3 patients treated with peg interferon alpha-and ribavirin. 

Vaccines

GI-5005

Pre-conference summary: A therapeutic vaccine that is in phase II studies. In a Phase 2b study it was found that in people with HCV genotype 1 who were either treatment-naïve or prior non-responders and who received the triple combination of GI-5005, pegylated interferon and ribavirin that 74% achieved an end of treatment response.

· LB-6. GI-5005 Therapeutic Vaccine Plus Peg-IFN/Ribavirin Improves Sustained Virologic Response Versus Peg-IFN/Ribavirin In Prior Non-Responders With Genotype 1 Chronic HCV Infection