Back to top

Analyst Blog

Gilead Sciences, Inc. (GILD - Analyst Report) recently received encouraging news when the Data and Safety Monitoring Board (DSMB) recommended the continuation of the enrollment process of the company’s phase III study (ION-1) following a planned review of the safety data from the study.

The study is evaluating a fixed-dose combination of Gilead’s candidate sofosbuvir (formerly GS-7977) and ledipasvir (formerly GS-5885) with and without ribavirin (RBV) in treatment-naïve patients infected with the genotype 1 version of hepatitis C virus (HCV) infection.  

The DSMB gave its recommendation following its review of the safety data from 200 patients in all four arms of the ION-1 study in addition to SVR4 rates (sustained virologic response 28 days post treatment) from 100 HCV patients in the two cohorts of 12-week duration. Following the positive development, Gilead has started enrolling the remaining 600 patients in the study.

Apart from ION-1, Gilead is also evaluating the combination of sofosbuvir and ledipasvir in 400 treatment-experienced patients infected with the genotype 1 version of HCV in another phase III study (ION-2).  The company is evaluating the above combination with RBV for 12 weeks and with and without RBV for 24 weeks. The patients who are being evaluated in the study did not respond to treatment by a regimen containing pegylated interferon (peg-IFN) or peg-IFN and a protease inhibitor.

We note that apart from ION-1 and ION-2, Gilead is evaluating sofosbuvir in HCV patients in other phase III studies also. Gilead intends to seek regulatory approvals for the candidate in the US and EU, based on data from these studies, in the second quarter of 2013.

Successful development of sofosbuvir would not only boost Gilead’s top line, but also strengthen its position in the lucrative HCV market. A sizeable population suffers from HCV the world over.

Gilead carries a Zacks Rank #2 (Buy).  Pharma stocks such as Athersys, Inc. (ATHX - Snapshot Report), Cytokinetics, Inc. (CYTK - Snapshot Report) and Osiris Therapeutics, Inc. (OSIR - Analyst Report) carry a Zacks Rank #1 (Strong Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
TRIQUINT SE… TQNT 20.67 +6.52%
RF MICRO DE… RFMD 12.47 +6.04%
VASCO DATA… VDSI 14.77 +4.68%
BANCO DO BR… BDORY 15.53 +3.95%
STRATTEC SE… STRT 80.24 +3.00%