Data from Phase 3 studies of Gilead's sofosbuvir for hepatitis C to be presented at 48th Annual EASL Meeting; Findings published

Data from Phase 3 studies of Gilead's sofosbuvir for hepatitis C to be 
presented at 48th Annual EASL Meeting; Findings published online today in The 
New England Journal of Medicine 
AMSTERDAM, The Netherlands, April 23, 2013 /CNW/ - Gilead Sciences, Inc. 
(Nasdaq: GILD) today announced that detailed results from four Phase 3 
clinical trials (NEUTRINO, FISSION, POSITRON and FUSION) evaluating 
sofosbuvir, the company's investigational once-daily nucleotide NS5B inhibitor 
for the treatment of chronic hepatitis C virus (HCV) infection, will be 
presented this week in oral sessions at the 48th Annual Meeting of the 
European Association for the Study of the Liver (International Liver Congress 
2013) in Amsterdam, The Netherlands. In addition, detailed results from the 
four clinical studies have also been published online in two papers, ahead of 
print, in The New England Journal of Medicine (NEJM). 
In the four trials, sofosbuvir was administered to nearly 1,000 patients with 
chronic HCV infection as part of an all-oral 12-week or 16-week treatment 
regimen in combination with ribavirin (RBV) in genotypes 2 and 3, or with RBV 
and pegylated interferon (peg-IFN) for 12 weeks in genotypes 1, 4, 5 and 6. 
Overall SVR12 rates (sustained viral response 12 weeks after completing 
therapy) from 50 to 90 percent were observed. Patients who achieve SVR12 are 
considered cured of their HCV infection. 
A description of the four Phase 3 studies and SVR12 results are summarized in 
the table below. Detailed results from the Phase 3 studies of sofosbuvir are 
available at www.nejm.org/online-first. 
Sofosbuvir Phase 3 Studies 
 _____________________________________________________________________
|Study   |Population     |Treatment groups              |SVR12 Rates  |
|________|_______________|______________________________|_____________|
|        |Genotype       |Sofosbuvir + RBV + Peg-IFN for|             |
|NEUTRINO|1/4/5/6        |12 weeks                      |90% (295/327)|
|        |treatment-naïve|                              |             |
|________|_______________|______________________________|_____________|
|        |Genotype 2/3   |Sofosbuvir + RBV for 12 weeks |67% (107/253)|
|FISSION |treatment-naïve|or                            |67% (162/243)|
|        |               |Peg-IFN + RBV for 24 weeks    |             |
|________|_______________|______________________________|_____________|
|        |Genotype 2/3,  |Sofosbuvir + RBV for 12 weeks |             |
|POSITRON|IFN intolerant,|or                            |78% (161/207)|
|        |ineligible or  |Placebo for 12 weeks          |0% (0/71)    |
|        |unwilling      |                              |             |
|________|_______________|______________________________|_____________|
|        |Genotype 2/3   |Sofosbuvir + RBV for 12 weeks |50% (50/100) |
|FUSION  |treatment-     |or                            |73% (69/95)  |
|        |experienced    |Sofosbuvir + RBV for 16 weeks |             |
|________|_______________|______________________________|_____________| 
"There remains an urgent unmet medical need for individuals diagnosed with 
chronic hepatitis C infection," commented Ira Jacobson, MD, Chief of the 
Division of Gastroenterology and Hepatology, Vincent Astor Distinguished 
Professor of Medicine, The Joan Sanford I. Weill Medical College of Cornell 
University, Attending Physician, New York-Presbyterian Hospital Cornell 
Campus. "The breadth of data from the Phase 3 program evaluating sofosbuvir 
will help physicians understand how to treat the disease in the future across 
various HCV genotypes and patient populations." 
"In these particular studies, sofosbuvir-based HCV therapy demonstrated high 
efficacy rates and a favorable safety profile while reducing the need for 
interferon injections to 12 weeks, or eliminating interferon completely from 
the regimen," said Eric Lawitz, MD, President and Medical Director, The Texas 
Liver Institute, University of Texas Health Science Center, San Antonio. 
"Based on these findings, sofosbuvir, once approved, has the potential to play 
an important role in addressing the global hepatitis C epidemic." 
The NS5b region of the HCV viral genome for all patients who relapsed was 
sequenced and no S282T mutations were observed by population or deep 
sequencing (1 percent cutoff). There was no change in susceptibility to 
sofosbuvir or RBV observed by phenotypic analyses. 
With the exception of one patient in FISSION who was non-compliant, relapse 
accounted for all virologic failures. Adverse events were generally mild and 
included fatigue, nausea, headache, insomnia, pruritis, anemia and dizziness. 
Less than 2 percent of patients in the sofosbuvir treatment groups 
discontinued due to adverse events. 
On April 8, Gilead submitted a New Drug Application (NDA) to the U.S. Food and 
Drug Administration (FDA) for sofosbuvir for the treatment of HCV infection. 
The data submitted in the NDA support the use of sofosbuvir and RBV as an 
all-oral therapy for patients with genotype 2 and 3 HCV infection, and for 
sofosbuvir in combination with RBV and peg-IFN for treatment-naïve patients 
with genotype 1, 4, 5 and 6 HCV infection. 
Gilead plans to file for regulatory approval of sofosbuvir in other 
geographies, including the European Union, in the second quarter of 2013. The 
European Medicines Agency (EMA) has accepted Gilead's request for accelerated 
assessment for sofosbuvir, a designation that is granted to new medicines of 
major public health interest. Accelerated assessment could shorten the EMA's 
review time of sofosbuvir by two months. Granting of accelerated assessment 
does not guarantee a positive opinion from the CHMP or approval by the 
European Commission. 
About Sofosbuvir
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B protein, which 
plays an essential role in HCV replication. Sofosbuvir is a direct-acting 
agent, meaning that it interferes directly with the HCV life cycle by 
suppressing viral replication. Sofosbuvir is intended to become a cornerstone 
of interferon-free, all-oral treatment regimens for HCV that achieve higher 
cure rates more rapidly and with fewer side effects than current therapeutic 
options. Sofosbuvir is an investigational product and its safety and efficacy 
have not yet been established. 
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and 
commercializes innovative therapeutics in areas of unmet medical need. The 
company's mission is to advance the care of patients suffering from 
life-threatening diseases worldwide. Headquartered in Foster City, California, 
Gilead has operations in North America, Europe and Asia Pacific. 
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of 
the Private Securities Litigation Reform Act of 1995 that are subject to 
risks, uncertainties and other factors, including the risk that FDA and other 
regulatory agencies may not approve sofosbuvir, and that any marketing 
approvals, if granted, may have significant limitations on its use. Additional 
clinical studies of sofosbuvir, including in combination with other compounds, 
may not produce favorable results. As a result, Gilead may not be able to 
successfully commercialize sofosbuvir, and may make a strategic decision to 
discontinue its development if, for example, the market for the product fails 
to materialize as expected. These risks, uncertainties and other factors could 
cause actual results to differ materially from those referred to in the 
forward-looking statements. The reader is cautioned not to rely on these 
forward-looking statements. These and other risks are described in detail in 
Gilead's Annual Report on Form 10-K for the year ended December 31, 2012, as 
filed with the U.S. Securities and Exchange Commission. All forward-looking 
statements are based on information currently available to Gilead, and Gilead 
assumes no obligation to update any such forward-looking statements. 
For more information on Gilead Sciences, please visit the company 's website 
at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead 
Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. 
CONTACTS: 
Patrick O'Brien, Investors +1 (650) 522-1936 
Cara Miller, Media (U.S.) +1 (650) 522-1616 
Nick Francis, Media (EU) +44 (208) 587-2412 
SOURCE: Gilead Sciences, Inc. 
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-0- Apr/23/2013 16:17 GMT
 
 
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