This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Investigational Triple DAA Regimen Of Daclatasvir, Asunaprevir And BMS-791325 Achieved SVR12 Of 94% In Treatment-Naïve Patients With Genotype 1 Chronic Hepatitis C Infection In Phase II Trial

Stocks in this article: BMY

Bristol-Myers Squibb Company (NYSE: BMY) today announced for the first time Phase II data demonstrating that the 12-week Triple DAA treatment regimen of daclatasvir (DCV), asunaprevir (ASV), and BMS-791325 achieved sustained virologic response 12 weeks post-treatment (SVR 12) in 94% (15/16) of treatment-naïve, genotype 1 chronic hepatitis C patients. The remaining one patient had undetectable viral load at the end of treatment and was lost to follow-up until approximately 24 weeks post-treatment; in preliminary data, this patient has achieved SVR 24. The Phase II results from this interferon-, ribavirin- and ritonavir-free investigational regimen combining three different classes of direct-acting antivirals (DAAs) – an NS5A replication complex inhibitor (DCV), an NS3 protease inhibitor (ASV) and an NS5B non-nucleoside polymerase inhibitor (BMS-791325) – were presented today at the American Association for the Study of Liver Diseases congress in Boston.

One serious adverse event was reported in this study and was determined by the investigator to be unrelated to study drug. There were no discontinuations due to adverse events. Headache was the most common adverse event in the study (31%, 10/32).

“We are encouraged that this 12-week daclatasvir-based regimen with compounds in different classes of DAAs achieved SVR 12 in a majority of patients without the use of interferon, ribavirin or ritonavir,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The development of regimens for hepatitis C with the potential to avoid the use of ribavirin and ritonavir is an important approach in this therapeutic area, and we look forward to studying it further.”

Phase II studies of this investigational Triple DAA regimen are ongoing. Phase III development is anticipated to begin in 2014.

Daclatasvir is the first NS5A replication complex inhibitor to be investigated in HCV clinical trials and is currently in Phase III development. Asunaprevir is an oral, NS3 protease inhibitor in Phase III development with daclatasvir. BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase II development for hepatitis C as a component of daclatasvir-based treatment regimens.

1 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

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.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,828.24 +0.49 0.00%
S&P 500 2,067.56 -5.27 -0.25%
NASDAQ 4,791.63 +4.3130 0.09%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs