This Day On The Street
Continue to site
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

Gilead Announces Full 24-Week Phase 2 Results For Once-Daily Single Tablet HIV Regimen Containing Novel Prodrug Tenofovir Alafenamide (TAF)

Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed 24-week results from a Phase 2 study (Study 102) evaluating a once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection. A regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg was found to be similar to Stribild ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the percentage of patients with HIV RNA levels less than 50 copies/mL at 24 weeks of treatment. These findings were presented today in a latebreaker session (Abstract #99LB) at the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013) taking place in Atlanta.

“Given that HIV is now a chronic disease that can be managed with life-long therapy, there remains a need for new treatment options that are well tolerated,” said Andrew Zolopa, MD, Professor of Medicine, Infectious Diseases, Stanford University School of Medicine and an investigator for Study 102. “In this study, a TAF-based single tablet regimen achieved comparable viral suppression to Stribild while demonstrating improvement in renal and bone safety indicators.”

In Study 102, HIV-positive treatment-naïve adult patients were randomized (2:1) to receive the investigational TAF-based regimen or Stribild. At 24 weeks, 87 percent (n=97/112) of patients taking TAF and 90 percent (n=52/58) of patients taking Stribild achieved HIV RNA (viral load) less than 50 copies/mL, based on the FDA snapshot algorithm (95 percent CI for the difference: -15.7 percent to 5.9 percent for TAF vs. Stribild; p=0.36). There were no statistically significant differences in the frequency and nature of Grades 3-4 laboratory abnormalities, and the frequency and nature of adverse events were similar between the two arms. Both regimens were generally well tolerated.

“We are pleased with these positive Phase 2 data, which we believe demonstrate that TAF-based single tablet regimens have the potential to play an important role in HIV therapy,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “Our Phase 3 program for TAF is enrolling rapidly, and we look forward to sharing initial results from the first pivotal study in 2014.”

1 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 17,692.13 -53.85 -0.30%
S&P 500 2,107.66 -0.97 -0.05%
NASDAQ 5,136.9670 +8.1820 0.16%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs