Gilead Announces Results From Phase 3 Study of Sofosbuvir Among Hepatitis C
Patients in Japan
– Results Confirm Efficacy and Safety of All-Oral Sofosbuvir-Based Regimen for
Genotype 2 HCV Patients –
– Japanese Regulatory Filing Planned for Mid-Year –
FOSTER CITY, Calif. -- April 2, 2014
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-naïve 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
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 sofosbuvir
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 Sciencesis 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 inFoster City, California,
Gilead has operations inNorth and South America,EuropeandAsia Pacific.
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 forward-looking
U.S. full prescribing information for Sovaldi is available at www.Gilead.com
Sovaldi is a registered trademark ofGilead Sciences, Inc.
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.
Gilead Sciences, Inc.
Patrick O’Brien, Investors, 650-522-1936
Cara Miller, Media (U.S.), 650-522-1616
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