New HCV Drugs and Drug Resistance, Report from EASL liver meeting in Milan, Apri

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New HCV Drugs and Drug Resistance, Report from EASL liver meeting in Milan, April 2008http://www.natap.orgJules LevinThere are many new drugs in development as therapy for the hepatitis C virus (HCV). The potential orally administered new drugs are at various stages in development. Many of them have not yet been discussed publicly. Below are the new HCV drugs that were discussed at the liver meeting EASL last week in Milan. They include HCV protease inhibitors telaprevir, boceprivir, and TMC435. Several NNRTI and NRTI polymerase inhibitors were discussed, of note R7128 and R1626 are the furthest along in studies in patients and are of the most interest. At this time and for the forseeable future peginterferon and ribavirin will be included in therapy regimens but with the addition of an oral drug or two duration of therapy will likely be shortened and the viral response rates are expected to improve quite a lot. Telaprevir phase III studies are starting and nboceprevir phase III studies are expected to begin. The Roche-Intermune protease inhibitor is not as far along in development yet and there was no new data on it here in Milan, But I think we will hear new information soon as I'm sure accelerated development is expected. Of interest Roche has 3 oral drugs in development: the Intermune protease inhibitor and R1626 and T7128.HCV Drug Resistance, Review of New HCV Drugs - (04/23/08)New HCV Drugs Panel Discussion at EASL 2008- (04/30/08)Treatment of Chronic Hepatitis C with Telaprevir (TVR) in Combination with Peginterferon Alfa-2a with or without Ribavirin: Interim Results of the PROVE2 Study - (05/02/08)HCV Protease Inhibitor Telaprevir, PROVE1 Study: final results of a phase 2 study with peginterferon plus ribaviron in treatment-naive patients with hepatitis C- (04/25/08)A Study of Telaprevir (TVR) with Peginterferon Alfa-2a (P) and Ribavirin ® in Subjects with Well-Documented Prior PR Null Response, Non-Response or Relapse: Preliminary Results - (04/25/08)Vertex Press ReleasesVertex Announces Positive Interim Results with Telaprevir-based Therapy in Genotype 1 Chronic Hepatitis C Patients who Failed to Achieve SVR with Previous Pegylated Interferon & Ribavirin Treatment - (04/24/08) Telaprevir-Based PROVE Studies Show Significantly Higher SVR Rates in Treatment-Naive Genotype 1 Hepatitis C Patients in Half the Time of Current Treatments - (04/24/08)DEVELOPMENT- Interim Phase 2 RVR/EVR Results- Boceprevir Study- HCV Protease Inhibitor- (04/30/08)Romark Announces Presentation of New Data For Nitazoxanide in Chronic Hepatitis C at EASL 2008 - (04/29/08)POTENT ANTIVIRAL ACTIVITY OF THE HCV NUCLEOSIDE POLYMERASE INHIBITOR, R7128, IN COMBINATION WITH PEG-IFN a-2a AND RIBAVIRIN - (05/06/08) High end-of-treatment response (84%) after 4 weeks of R1626, peginterferon alfa-2a (40KD) and ribavirin followed by a further 44 weeks of peginterferon alfa-2a and ribavirin - (05/06/08)IV Silymarin; SILIBININ IS A POTENT ANTIVIRAL AGENT IN CHRONIC HEPATITIS C NOT RESPONDING TO ANTIVIRAL COMBINATION THERAPY - (05/02/08)Efficacy and safety of increasing doses of the cyclophilin inhibitor Debio 025 in combination with pegylated interferon alpha-2a in treatment naive chronic HCV patients- (04/28/08)ONCE-DAILY REGIMENS OF THE HCV NS3/4A-PROTEASE INHIBITOR TMC435350 ARE PREDICTED TO PROVIDE THERAPEUTIC EXPOSURE IN PLASMA AND LIVER - (04/25/08) Safety of the HCV Protease Inhibitor TMC435350 in Healthy Volunteers and Safety and Activity in Chronic Hepatitis C Infected Individuals: A Phase I Study - (04/25/08)Results of a Safety, Tolerability and Pharmacokinetic Phase I Study of VCH-916, a Novel Polymerase Inhibitor for HCV, Following Single Ascending Doses in Healthy Volunteers - (05/02/08) Preclinical Pharmacokinetic and ADME Characterization of VCH-916, a Novel Non-Nuclesoside HCV NS5B Polymerase Inhibitor - (05/02/08) Genotypic analysis of HCV NS5B variants selected from patients treated with VCH-759, and Viral Load Declines - (05/02/08)Potent Antiviral Activity of 2nd Generation HCV Nucleotide Inhibitors, IDX102 and IDX184, in HCV-infected Chimps - (04/28/08) In Vitro Activity and Pharmacologic Properties of Two Novel Series of HCV Protease Inhibitors - (04/28/08)Here is link to all articles so far reported as coverage from EASL, including HBV data which includes of note important updates on tenofovir for HBV, and entecavir. Lots of new information was presented on Pegasys and PegIntron and of note new data from the HALT-C study which is particularly noteworthy; you should read my commentaries on the data from HALT-C: