icon-folder.gif   Conference Reports for NATAP  
 
  EASL 48th Annual Meeting
April 24th - 28th 2013
The Netherlands, Amsterdam
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HCV New Drugs - Report 3 (ELECTRON Study phase 2: GS7977+Rbv GT1)
 
 
  Reported by Jules Levin
 
This report was also originally filed & distributed via the NATAP listserve live & real-time from EASL on Sunday the day EASL ended.
 
EASL: ELECTRON: All-Oral Sofosbuvir-Based 12-Week Regimens for the Treatment of Chronic HCV GT 1 Infection - (04/27/13)
 
Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients - (04/01/13) Phase 3 ION-1 and ION-2 studies GS7977+GS5885 with & without Rbv in treatment-naives & patients who failed previous therapy with either Peg/Rbv or triple therapy with a protease+Peg/Rbv.
 
EASL: 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 - (04/23/13)
 
EASL: Treatment With Sofosbuvir + Peginterferon + Ribavirin for 12 Weeks Achieves 90% SVR12 in Treatment-Naïve Genotype 1, 4, 5, and 6 HCV-Infected Patients: The NEUTRINO Study - (04/27/13)
 
EASL: Once-Daily Sofosbuvir Plus Ribavirin Given for 12 or 24 Weeks in Treatment-Naïve Patients With HCV Infection: the QUANTUM Study - (04/28/13)
 
I count I think 6 phase 3 studies for Gilead in HCV covering across the genotypes, take a look at the 2 links above listing the various phase 3 studies. The ELECTRON Study is a phase 2 of about 94 patients looking at both treatment-naives & null responders with each of 3 treatment arms for 12 weeks therapy: GS7977+Rbv, GS7977+GS5885 (NS5A)+Rbv and GS7977+GS9669 (non-nuc)+Rbv. These were 90% Gt1a patients without cirrhosis, phase 3 will include cirrhotics. You can view the ELECTRON slide presentation here at EASL with the link above. Here is the results slide just below showing 100% in naives (25/25) with the 3-drug regimen of GS7977+GS5885+Rbv & 100% in nulls with the same regimen, phase 3 ION studies will look at with & without Rbv with the coformulation of GS7977+GS5885. You can see this study also looked at GS7977+GS9669 (non-nuc)+Rbv with 92% SVR in naives (23/25) & 3/3 SVR in nulls all with 12 weeks, ION-2 will look at treatment-experienced with 12 and 24 weeks therapy.

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