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Alan Franciscus
HCV Advocate

Wednesday, April 18, 2012

Gilead Sciences to Present New Hepatitis B and C Data at European Conference on Liver Disease This Week

-- Presentations Include First Results For Lead Hepatitis C Candidate GS-7977 In Treatment-Naive Genotype 1 Patients -- 

BARCELONA, Spain, Apr 18, 2012 (BUSINESS WIRE) -- Gilead Sciences, Inc. GILD +0.45% today announced that 30 abstracts examining the company's products and investigational agents for hepatitis B and C have been selected for presentation at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) taking place April 18-22 in Barcelona, Spain. The abstracts describe clinical and preclinical data for a number of investigational chronic hepatitis C compounds, as well as new long-term data for Viread(R) (tenofovir disoproxil fumarate) for chronic hepatitis B. 

Presentations will include data from several studies examining Gilead's late-stage nucleotide analog polymerase inhibitor, GS-7977, in treatment-naive genotype 1 hepatitis C patients. Genotype 1 is the most prevalent strain of the hepatitis C virus (HCV), and also the hardest to treat with existing therapies. Data from ELECTRON (Poster #1113) and ATOMIC (Oral Abstract #1) will be presented and both studies have been selected for inclusion in official EASL Press Office activities. 

In addition to GS-7977, Gilead is advancing multiple oral compounds with different mechanisms of action with the goal of creating an efficacious, well tolerated and convenient all-oral treatment regimen for chronic HCV. Notably, data will be presented for two of these compounds, GS-5885 (an NS5A inhibitor) and GS-9669 (a non-nucleoside polymerase inhibitor):
  • Interim efficacy and safety results for a Phase 2 study (Study 120) examining 12 weeks of treatment with GS-5885, GS-9451, tegobuvir (GS-9190) and ribavirin. Based on the results of this trial and other studies involving more than 800 patients treated with GS-5885 for at least 12 weeks, Gilead has selected a 90 mg dose of GS-5885 for further clinical development (Latebreaker Poster #1421).
  • Results of a three-day, Phase 1, ascending-dose study, which demonstrate the potent antiviral activity of GS-9669, a non-nucleoside polymerase inhibitor, when administered once-daily (Poster #1189). 
Seven abstracts at the International Liver Congress will highlight the safety and efficacy profile of Viread, the most-prescribed treatmentfor chronic hepatitis B in the United States and major countries of Europe. Notably, new data further characterize Viread's well-established renal safety profile:
  • The VIREAL prospective cohort study reports on 115 chronic hepatitis B patients with reduced renal function at baseline, the majority of whom either remained stable or improved after 48 weeks of treatment with Viread (Poster #531). 
Abstracts for Gilead's presentations can currently be accessed on the EASL website, with the exception of the ELECTRON and ATOMIC studies, which are embargoed until Thursday, April 19, 2012 due to their inclusion in the press program of the International Liver Congress. Gilead will issue press releases describing the data from these studies. Further information about these studies can also be found at www.clinicaltrials.gov . 

GS-7977, GS-5885, GS-9669, GS-9451 and tegobuvir (GS-9190) are investigational products and their safety and efficacy have not yet been established. 

Read complete release here

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