This Day On The Street
Continue to site
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’s Once-Daily Single Tablet Regimen Complera® Maintains HIV Suppression Among Patients Switching From Protease Inhibitor-Based Regimens

Gilead Sciences, Inc. (Nasdaq: GILD) today announced 24-week data from a Phase 3 clinical trial, SPIRIT ( Switching boosted PI to Rilpivirine In Combination with Truvada as a Single Tablet Regimen), which evaluated virologically suppressed treatment-experienced HIV patients switching from a multi-pill regimen containing a ritonavir-boosted protease inhibitor to the once-daily single tablet regimen Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate). The study met its 24-week primary endpoint, which found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen. These findings will be presented today in an oral session (Abstract #TUAB0104) at the 19th International AIDS Conference (AIDS 2012) in Washington, D.C.

“Since its approval last year for patients new to HIV therapy, the daily single tablet regimen of Complera has become an important addition to the list of treatment options available for these patients,” said Frank J. Palella Jr., MD, Professor of Medicine at the Northwestern University Feinberg School of Medicine and Principal Investigator of the SPIRIT study. “In this current study, data demonstrate Complera has the potential to help a broader range of HIV-infected patients.”

Complera was approved by the U.S. Food and Drug Administration (FDA) in August 2011 for treatment-naïve patients, and is the latest complete HIV regimen available in a once-daily single tablet. The product combines Gilead’s Truvada ® (emtricitabine and tenofovir disoproxil fumarate), which itself is a fixed-dose combination of two HIV medicines, with Janssen R&D Ireland’s rilpivirine (marketed as Edurant ®).

At 24 weeks of treatment, 94 percent of patients (n=297/317) who switched to Complera maintained HIV RNA (viral load) levels less than 50 copies/mL compared to 90 percent of patients (n=143/159) who remained on a regimen containing a ritonavir-boosted protease inhibitor-based regimen (FDA snapshot algorithm; 95 percent CI for the difference: -1.6 percent to +9.1 percent; predefined criterion for non-inferiority was the lower bound of a two sided 95 percent CI of -12 percent). Fewer patients taking Complera experienced virologic failure compared to those taking a protease-based regimen (0.9 percent versus 5 percent, respectively). Additionally, patients in the Complera arm demonstrated statistically significant improvements in total cholesterol levels. The ratio of total cholesterol to HDL (high-density lipoprotein or “good” cholesterol) declined by an average of 0.27 in the Complera arm, compared to an increase of 0.08 in the protease inhibitor arm (p<0.001).

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,090.54 +39.79 0.23%
S&P 500 2,013.43 +15.91 0.80%
NASDAQ 4,812.1050 +1.3170 0.03%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs