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 Sciences Scores First Win With Late-Stage Hep C Study

FOSTER CITY, Calif. ( TheStreet) -- Gilead Sciences (GILD - Get Report) reported positive results Tuesday from the first in a series of late-stage studies to support the regulatory approval of its hepatitis C pill sofosbuvir.

If approved, sofosbuvir will be the main component of the first all-oral combination regimen to treat hepatitis C, eliminating the need for traditional injectable drugs.

Gilead expects to seek approval of sofosbuvir in the middle of 2013.

This first phase III study, dubbed POSITRON, examined a 12-week course of therapy consisting of sofosbuvir (formerly known as GS-7977) plus the immune booster ribavirin. The study enrolled patients with genotype 2 or 3 hepatitis C who were not candidates for treatment with interferon, the injectable drug commonly used today.

Genotype 2/3 is less common in the U.S. than genotype 1 but still represents about one-third of all hepatitis C cases worldwide.

Seventy-eight percent of patients treated with sofosbuvir and ribavirin for 12 weeks achieved a sustained virologic response (SVR), the medical term that denotes a cure for hepatitis C. By comparison, none of the patients treated with a placebo in the study achieved a cure.

The 78% cure rate for sofosbuvir plus ribavirin met but didn't exceed Wall Street expectations, said ISI Group analyst Mark Schoenebaum, in an email to clients.

"As Gilead is a very high expectation stock, we would not expect the stock to move up much at all today, and could even trade down a bit," Schoenebaum writes.

Gilead shares were down less than 1% to $75 in early Tuesday trading.

Two additional phase III studies of sofosbuvir in genotype 2/3 patients are underway with results expected in the first quarter 2013. Phase III studies of sofosbivir in the more prevalent genotype 1 hepatitis C patient population are also being conducted, with results expected next year.

Gilead most promising and anticipated hepatitis C regimen consists of sofosbuvir, a so-called "nuc" polymerase inhibitor plus GS-5885, an NS5A inhibitor.

Abbott Labs (ABT - Get Report) has begun phase III studies of its own all-oral hepatits C regimens.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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
ABT $38.90 0.00%
GILD $88.21 0.00%
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs