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Gilead HCV Program, GS-7977
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from Jules: Gilead submitted to the FDA approval for the Gilead nucleotide GS-7977+Peg/Rbv 12 weeks for Gt1, and for GS7977+Rbv for Gt2/3 and I think 4/6. They have been studying HIV/HCV coinfection in Gt2 and I think Gt1. The FDA hearing for TMC435 & for GS-7977 appears to be Oct 24/25 2013. There is a lot of research & studies that have been conducted so there is a lot below, you can look at the phase 3 results presented at EASL 2013, link below. Gilead has a protease inhibitor & a non-nuc as well in clinical development, studies presented at EASL 2013. GS-7977 has been studied in combination with BMS' NS5A inhibitor in naives & telaprevir/boceprevir failures with 95-100% SVR rates. In 2014 by June Gilead is expected to submit phase 3 study results to the FDA for their fixed dose combination go GS-7977 + their 1st generation NS5A with and w/o RBV, 12 weeks therapy. At the same time Abbvie will be submitting their Phase 3 study results for their INF-free oral regimen which includes their protease inhibitor, NS5A inhibitor & their non-nuc with & w/o RBV, 12 weeks therapy; GS-7977 mono therapy data is reported in study links below.
GS-7977 & HIV ARTs PK - No Clinically Significant Pharmacokinetic Interactions Between Sofosbuvir (GS-7977) and HIV Antiretrovirals Atripla, Rilpivirine, Darunavir/Ritonavir, or Raltegravir in Healthy Volunteers
http://www.natap.org/2012/AASLD/AASLD_64.htm
GILEAD SUBMITS NEW DRUG APPLICATION TO U.S. FDA FOR SOFOSBUVIR FOR THE TREATMENT OF HEPATITIS C
http://www.natap.org/2013/HCV/040813_01.htm
Antiviral Drugs Advisory Committee .........October 24-25
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm
Gilead Reports Interim Data From Phase 2 LONESTAR Study - (05/03/13)
EASL 2013
Gilead reported 7 studies results including 4 phase 3 studies and others including their HCV protease inhibitor, 1st & 2nd generation NS5A inhibitors and their non-nuc, ALL with links to each presentation within this report
http://www.natap.org/2013/HCV/050313_02.htm
Clin Pharm Workshop at EASL Amsterdam 2013 - Clinical Pharmacology of DAA's for HCV:
What's New and What's in the Pipeline
Gilead Sciences A. Mathias Pres.
DATA FROM PHASE 3 STUDIES OF GILEAD'S SOFOSBUVIR FOR HEPATITIS C TO BE PRESENTED AT 48TH ANNUAL EASL MEETING; FINDINGS PUBLISHED ONLINE TODAY IN THE NEW ENGLAND JOURNAL OF MEDICINE - Press Release
http://www.natap.org/2013/EASL/EASL_02.htm
Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection: 2 phase 3 studies - FISSION (gt2/3), NEUTRINO (gt1)
http://www.natap.org/2013/EASL/EASL_32.htm
Gilead's HCV Pipeline Unveiled at EASL
http://www.natap.org/2011/EASL/EASL_97.htm
A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C
http://www.natap.org/2012/HCV/062012_04.htm
Antiviral Activity and Resistance Profile of the Novel HCV NS5A Inhibitor GS-5885
http://www.natap.org/2012/EASL/EASL_62.htm
NS5A Review - Small molecule inhibitors of the hepatitis C virus-encoded NS5A protein
http://www.natap.org/2013/HCV/022513_01.htm
EASL: Sustained Virologic Response With Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) in Chronic HCV Genotype (GT) 1-Infected Patients Who Previously Failed Telaprevir (TVR) or Boceprevir (BOC) - (04/27/13)
EASL/2012: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)
COSMOS Study: SVR4 results of a once daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 null responders
http://www.natap.org/2013/CROI/croi_34.htm
AASLD/2012: High Rate of Sustained Virologic Response With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naive Patients Chronically Infected With HCV GT 1, 2, or 3 - (11/13/12)
EASL: No S282T Mutation Detected by Deep Sequencing in a Large Number of HCV Patients Who Received Sofosbuvir With RBV and/or GS-0938: the Quantum Study - (04/29/13)
EASL: GS-5816, a Second-Generation HCV NS5A Inhibitor With Potent Antiviral Activity, Broad Genotypic Coverage, and a High Resistance Barrier - (04/29/13)
EASL: Healthy Volunteer First-in-Human Evaluation of GS-5816, a Novel Second Generation Broad-Genotypic NS5A Inhibitor With Potential for Once-Daily Dosing - (04/29/13)
GILEAD PROVIDES UPDATE ON HEPATITIS C DEVELOPMENT PROGRAMS - update on GS-7977+GS-5885+Rbv in null responders in Electron
http://www.natap.org/2013/HCV/010713_02.htm
GS-7977 400 mg QD Safety and Tolerability in the Over 500 Patients Treated for at Least 12 Weeks
http://www.natap.org/2012/EASL/EASL_55.htm
Once Daily Sofosbuvir (GS-7977) Regimens in HCV Genotype 1-3: The ELECTRON Trial
http://www.natap.org/2012/AASLD/AASLD_31.htm
AASLD: Once Daily Sofosbuvir (GS-7977) plus PEG/RBV In Treatment-Na•ve Patients With HCV Genotype 1, 4, and 6 Infection: The ATOMIC Study http://www.natap.org/2012/AASLD/AASLD_21.htm
http://www.natap.org/2013/HCV/033113_02.htm
Nucleotide Polymerase Inhibitor Sofosbuvir (GS-7977) plus Ribavirin for Hepatitis C - new published study
http://www.natap.org/2013/HCV/010413_04.htm
ONCE DAILY DUAL-NUCLEOTIDE COMBINATION OF PSI-938 AND PSI-7977 PROVIDES 94% HCV RNA < LOD AT DAY 14: FIRST PURINE/PYRIMIDINE CLINICAL COMBINATION DATA (THE NUCLEAR STUDY)
http://www.natap.org/2011/EASL/EASL_07.htm
Pharmasset Announces Results of a 28-day Phase 2a Study with PSI-7977 for the Treatment of Chronic Hepatitis C Infection
http://www.natap.org/2010/HCV/102810_04.htm
AASLD: PSI-7977: ELECTRON Interferon is not required for Sustained Virologic Response in Treatment-Na•ve Patients with HCV GT2 or GT3 - (11/07/11)
Lack of Effect of the Nucleotide Analog
Polymerase Inhibitor PSI-7977 on Methadone PK and PD
http://www.natap.org/2011/AASLD/AASLD_104.htm
PSI-7977 Has No Effect on QTcF Intervals at Therapeutic or Supratherapeutic Doses
http://www.natap.org/2011/AASLD/AASLD_103.htm
PSI-7977 with PEG/RBV Elicits Rapid Declines in HCV RNA in Patients with HCV GT-4 and GT-6
http://www.natap.org/2011/hepDART/hepDART_01.htm
High Rapid Virologic Response (RVR) with PSI-7977 Daily Dosing plus PEG-IFN/RBV in a 28-day Phase 2a Trial
http://www.natap.org/2010/AASLD/AASLD_49.htm
Gilead Acquires Pharmasset $11 Billion
http://www.natap.org/2011/HCV/112111_02.htm
TMC435+GS7977 (Rbv) New Study in Advanced Hepatic Fibrosis- Null Responders & Naives
http://www.natap.org/2013/HCV/012213_03.htm
Combination of two complementary nucleotide analogues, PSI-7977 and PSI-938, effectively clears wild type and NS5b: S282T HCV replicons - Comparison with combinations of other antiviral compounds
http://www.natap.org/2010/EASL/EASL_28.htm
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