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 Once-Daily Single Tablet Regimen StribildTM Maintains High Viral Suppression Through Two Years Of Therapy Among Treatment-Naïve HIV Patients

Median changes from baseline in total cholesterol, HDL (high-density lipoprotein or “good” cholesterol) and LDL at 96 weeks were, respectively, +9, +6 and +9 mg/dL for Stribild and +18, +8 and +16 mg/dL for Atripla (total cholesterol, p<0.001; HDL, p=0.008; LDL, p=0.011). The median change in triglycerides was +4 mg/dL for Stribild and +8 mg/dL for Atripla (p=0.41).

Study 103

Study 103 is a randomized (1:1), double-blind Phase 3 clinical trial comparing the efficacy, safety and tolerability of Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (n=353) versus atazanavir 300 mg boosted by ritonavir 100 mg plus Truvada (emtricitabine and tenofovir disoproxil fumarate) (n=355) among HIV-infected treatment-naïve adults with baseline HIV RNA levels > 5,000 copies/mL. The primary endpoint of the study is the proportion of patients achieving HIV RNA levels < 50 copies/mL at 48 weeks of treatment, per the FDA snapshot algorithm. Secondary objectives will evaluate the efficacy, safety and tolerability of the treatment regimens through 192 weeks of treatment.

At baseline, patients in the Stribild arm had a median HIV RNA of 4.88 log 10 copies/mL and mean CD4 cell count of 364 cells/mm 3. Patients in the atazanavir-based arm had a median HIV RNA of 4.86 log 10 copies/mL and mean CD4 cell count of 375 cells/mm 3. Across both arms, 41 percent of patients had HIV RNA > 100,000 copies/mL and 13 percent had CD4 counts ≤ to 200 cells/mm 3.

At 96 weeks, patients in both arms experienced similar increases in CD4 cell counts (mean increase of 256 cells/mm 3 for Stribild and 261 cells/ mm 3 for the atazanavir-based regimen). The virologic failure rate was 7 percent for both treatment regimens. Five percent of Stribild patients and 6 percent of patients on the atazanavir-based regimen discontinued treatment due to adverse events. The most common adverse events leading to treatment discontinuation among patients taking Stribild were renal events, diarrhea, pyrexia, nausea, vomiting and fatigue. Between 48 and 96 weeks of treatment, one Stribild patient and one patient in the atazanavir-based regimen discontinued due to serum creatinine increase without features of proximal renal tubulopathy, and both patients improved after treatment discontinuation.

Ocular icterus (associated with elevated bilirubin levels) was less common among Stribild patients (less than 1 percent) compared to patients taking the atazanavir-based regimen (14 percent).

4 of 8

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!
DOW 16,987.51 -61.49 -0.36%
S&P 500 1,985.54 -11.91 -0.60%
NASDAQ 4,567.5980 -24.2080 -0.53%

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