Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) For An Interferon-Free Regimen Of Sofosbuvir (GS-7977), GS-5885 And Ribavirin In Treatment-Naïve Genotype 1 Hepatitis C Infected Patients
Gilead Sciences (Nasdaq: GILD) today announced interim data from the ongoing Phase 2 ELECTRON study examining a 12-week course of therapy with the investigational nucleotide sofosbuvir (formerly referred to as GS-7977), the NS5A inhibitor GS-5885 and ribavirin in patients with genotype 1 chronic hepatitis C virus (HCV) infection. Among treatment-naïve patients receiving this combination, 100 percent (n=25/25) remained HCV RNA undetectable four weeks after completing therapy (SVR4). These data will be presented on Tuesday, November 13 th at the 63rd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2012) in Boston.
“These results indicate that adding GS-5885 to sofosbuvir-based regimens may enhance SVR rates, potentially offering HCV genotype 1 infected patients a convenient 12-week course of oral therapy,” said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON study. “Along with other data from the ELECTRON study, these results add to the growing body of evidence supporting the potential for effective sofosbuvir-based all-oral regimens.”
Gilead recently initiated the first Phase 3 trial (ION-I) evaluating a fixed-dose combination of sofosbuvir and GS-5885 in treatment-naïve genotype 1 patients. This four-arm study is evaluating the fixed-dose combination with and without ribavirin for 12-and 24-week durations in 800 patients, 20 percent of whom have evidence of cirrhosis.
Data from five additional arms of the ELECTRON study examining sofosbuvir-based therapy in various patient populations also will be presented:
|Sofosbuvir + ribavirin for 12 weeks||GT 1 treatment-naïve||84% (21/25) SVR12|
|GT 1 null responders||10% (1/10) SVR12|
|GT 2/3 treatment-experienced||68% (17/25) SVR12|
|Sofosbuvir + ribavirin for 8 weeks||GT 2/3 treatment-naïve||64% (16/25) SVR12|
|Sofosbuvir + ribavirin (800 mg) for 12 weeks||GT 2/3 treatment-naïve||60% (6/10) SVR8|
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV