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Gilead's HCV Pipeline Unveiled at EASL
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from Jules: In addition to the headline stories from this landmark EASL hepatitis C meeting including curing 4/11 patients with 2 BMS oral HCV drugs without peg/rbv, and the potency of Pharmasset's nucleotides showing almost 100% rates of undetectability in early data, there was Gilead with many posters revealing for the first time as far as I know a new more potent HCV protease GS-9451, a nucleotide of their own GS-6620, and a NS5A inhibitor of their own as well GS-5885. At the meeting several other companies revealed their own new NS5A & nucleotide inhibitors as well. And Gilead introduced their orally administered immune-based TLR7 agonist GS-9620 which shows activity in HBV & HCV. This is quite an ambitious pipeline. One pill once a day, a coformulated HCV 'Atripla' may be a goal. There were many additional significant developments reported at EASL discussed in the Brief Recap below. Also, new data & study results were reported for new 2nd generation protease inhibitors. A significant development is Boerhinger Ingelheim starting phase 3 with their HCV protease. Another is Tibotec having announced before the meeting entering phase 3 with their HCV protease TMC435. Abbott & Roche both reported new data on their low-dose ritonavir boosted HCV proteases at EASl. Of note Novartis reported large phase 2 study nice looking results of their cyclophillin inhibitor and announced they are entering phase 3. GSK unveiled for the 1st time their new 2 HCV drugs: a NS5A inhibitor and a polymerase inhibitor. Of course there was a lot of studies presented on telaprevir & boceprevir and IL-28B and lead-in with lead-in showing little or no benefit with telaprevir in the REALIZE Study but obviously crucial with boceprevir use, an important study on boceprevir adherence. BMS reported on a 2nd generation NS5A inhibitor. And then of course there is the ongoing controversial subject of HCV protease resistance issue. The issue and speculation about telaprevir & boceprevir pricing was circulating throughout the hallways. Access in Europe & beyond to new HCV drugs was also a topic for me that I engaged in discussions about which appear in question due to in part I think economic concerns in Europe & globally and that HCV does not get that much attention outside the western countries.
Brief Recap Report from EASL Liver Conference in Berlin: state of HCV Now- policy, treatment, access - (04/04/11)
HCV Drug Resistance - (04/06/11)
Eurpopean Association for the Study of the Liver
March 30th - April 3rd 2011
Berlin, Germany
Gilead Studies
Four-Week Treatment with GS-9256 and Tegobuvir (GS-9190) +/- RBV +/- PEG, Results in Enhanced Viral Suppression on Follow-up PEG/RBV Therapy, in Genotype 1a/1b HCV Patients - (04/05/11)
Therapeutic Efficacy of a TLR7 Agonist for HBV Chronic Infection in Chimpanzees - (04/07/11)
Anti-Viral Efficacy and Induction of an Antibody Response Against Surface Antigen with the TLR7 Agonist GS-9620 in the Woodchuck Model of Chronic HBV Infection - (04/07/11)
Three-Day, Dose-Ranging Study of the HCV NS5A Inhibitor GS-5885 - (04/06/11)
A Phase 2b Trial Comparing 24 to 48 Weeks Treatment with Tegobuvir (GS-9190)/PEG/RBV to 48 Weeks Treatment with PEG/RBV for Chronic Genotype 1 HCV Infection - (04/06/11)
GS-6620: A Liver Targeted Nucleotide Prodrug with Potent Pan-Genotype Anti-Hepatitis C Virus Activity In Vitro - (04/06/11)
Emergence and Persistence of NS5B Mutations Following Combination Treatment with Tegobuvir (GS-9190) plus Standard of Care--Long-Term follow-Up from the Phase 2b Study GS-US-196-0103 - (04/06/11)
Preclinical Properties of the Novel HCV NS3 Protease Inhibitor GS-9451 - (04/06/11)
GS-6620, A Novel Anti-Hepatitis C Virus Nucleotide Prodrug, Has A High In Vitro Barrier To Resistance - (04/06/11)
Nonclinical and Cross-genotypic Profiles of GS-9669, a Novel HCV NS5B Non-nucleoside Thumb Site II Inhibitor - (04/06/11)
Preclinical Characterization of GS-9620, A Potent and Selective Oral TLR7 Agonist - (04/06/11)
A Phase-I, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Oral Doses of GS-9620 In Healthy Subjects - (04/06/11)
Genotypic and Phenotypic Characterization of HCV Resistance From a Multiple Dose Clinical Trial of GS-9451, a Novel NS3 Protease Inhibitor - (04/06/11)
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