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
TheStreet Open House

Gilead’s HIV Integrase Inhibitor Elvitegravir Dosed Once Daily As Effective As Twice-Daily Raltegravir Over Two Years Of Therapy In Pivotal Phase 3 Study

Stocks in this article: GILD

Trial participants received either once-daily elvitegravir (150 mg or 85 mg) or twice-daily raltegravir (400 mg). Patients’ background regimens were based on the results of resistance testing and included a fully-active ritonavir-boosted protease inhibitor, and a second agent that was permitted to be a nucleoside or nucleotide reverse transcriptase inhibitor, etravirine, maraviroc or enfuvirtide. Due to known pharmacokinetic interactions, patients randomized to elvitegravir whose background protease inhibitor was either atazanavir or lopinavir received an 85 mg dose of elvitegravir.

In January 2011, Gilead announced that it would extend the blinded, randomized period of Study 145 from the originally planned 48 weeks to 96 weeks in order to obtain longer-term safety and efficacy data. Based on the achievement of the non-inferiority endpoint at 48 weeks, patients continued to receive the regimen to which they were originally randomized in a blinded fashion through 96 weeks. Secondary endpoints included additional measures of the efficacy, safety and tolerability of the two treatment regimens.

At baseline, the median HIV RNA in the elvitegravir and raltegravir arms, respectively, was 4.35 log 10 copies/mL and 4.42 log 10 copies/mL. Median CD4 cell counts were 227 cells/mm 3 and 215 cells/mm 3 for the elvitegravir and raltegravir arms, respectively.

Mean increases in CD4 cell counts at Week 96 were 205 cells/mm 3 for elvitegravir patients and 198 cells/mm 3 for raltegravir patients. Virologic failure rates were similar in both arms: 26 percent for elvitegravir patients and 29 percent for raltegravir patients. Of those patients randomized, 7 percent of patients in each arm developed an integrase resistance mutation.

The most common Grade 2-4 adverse events occurring in greater than or equal to 5 percent of patients in either treatment arm were diarrhea, back pain, depression, bronchitis, upper respiratory tract infection, sinusitis, arthralgia and urinary tract infection. The incidence of these adverse events was similar in both treatment arms with the exception of diarrhea, which was more common in the elvitegravir arm (p=0.02).

2 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW
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 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

Partners Compare Online Brokers

Free Reports

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