|[April 02, 2014]
Gilead Announces Results From Phase 3 Study of Sofosbuvir Among Hepatitis C Patients in Japan
FOSTER CITY, Calif. --(Business Wire)--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced topline results from
a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the
once-daily nucleotide analog polymerase inhibitor sofosbuvir in
combination with ribavirin (RBV) for the treatment of genotype 2 chronic
hepatitis C virus (HCV) infection. The study met its primary efficacy
endpoint of superiority compared to a predefined historical control
sustained virologic response (SVR) rate. In the study, 97 percent
(n=148/153) of genotype 2 HCV-infected patients receiving 12 weeks of an
all-oral regimen of sofosbuvir plus RBV achieved a sustained virologic
response 12 weeks after completing therapy (SVR12). SVR12 rates among
treatment-na�ve and treatment-experienced patients were 98 percent
(n=88/90) and 95 percent (n=60/63), respectively. Of the 153 patients
who received treatment, 11 percent (n=17) had documented cirrhosis.
Japan has one of the highest rates of liver cancer of any industrialized
country, and the majority of cases are due to chronic HCV infection. An
estimated two million people in Japan are living with HCV infection, and
approximately 20-30 percent have the genotype 2 strain of the virus.
Current treatment options for genotype 2 HCV infection in Japan involve
up to 48 weeks of therapy with pegylated interferon injections, which
may not be suitable for certain patients.
In Study GS-US-334-0118, 153 patients (100%) became HCV undetectable by
treatment Week 4 and remained undetectable through the remainder of the
12-week treatment period. Post-treatment relapse accounted for five
virologic failures. There were no treatment discontinuations due to
adverse events and all patients completed the 12 week post-treatment
follow-up visit. The most common side effects observed in the study,
consistent with the population and safety profile of RBV, included
nasopharyngitis, anemia, headache, malaise and pruritis. Full study
results will be presented at a future scientific meeting.
"This study confirms the high efficacy of all-oral therapy with
sofosbuir among genotype 2 hepatitis C patients in Japan, regardless of
whether they are treatment experienced or new to treatment," said
Norbert Bischofberger, PhD, Executive Vice President of Research and
Development and Chief Scientific Officer, Gilead Sciences. "Based on
these trial results, Gilead anticipates submitting a New Drug
Application for sofosbuvir to the Japanese Pharmaceutical and Medical
Devices Agency (PMDA) by mid-2014."
Gilead established operations in Japan with the formation of Gilead K.K.
in Tokyo in September 2013. If approved by the PMDA, sofosbuvir would be
the first product to be launched and marketed by Gilead in Japan.
Gilead is also conducting a Phase 3 study in Japan evaluating the
efficacy and safety of a once-daily fixed-dose combination of the NS5A
inhibitor ledipasvir 90 mg and sofosbuvir 400 mg with and without
ribavirin for the treatment of patients with genotype 1 chronic HCV
infection, the most common strain of HCV in Japan. SVR12 results are
expected in the second half of 2014.
Sofosbuvir is an investigational product in Japan and its safety and
efficacy has not yet been established. The compound has been approved by
regulatory authorities in the United States, European Union and Canada
and is commercialized under the tradename Sovaldi®. The
ledipasvir/sofosbuvir fixed-dose combination is an investigational
product and its safety and efficacy has not yet been established.
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 and South
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
possibility of unfavorable results from additional clinical trials
involving sofosbuvir or the ledipasvir/sofosbuvir fixed-dose combination
in Japan, and the possibility we may not file for regulatory approval of
sofosbuvir in Japan in the currently anticipated timelines. Further, the
PMDA may not approve these products in Japan, and any marketing
approvals, if granted, may have significant limitations on its use.
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, 2013, 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
U.S. full prescribing information for Sovaldi is available at www.Gilead.com
Sovaldi is a registered trademark of�Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's
website at www.gilead.com,
follow Gilead on Twitter (News - Alert) (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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