Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of
Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response
(SVR12) Among Patients with Chronic Hepatitis C in Japan
-- Interferon- and Ribavirin-Free Therapy Effective against Genotype 1 HCV,
Japan’s Most Prevalent Strain of the Disease --
-- Japanese Regulatory Submission for Ledipasvir/Sofosbuvir Anticipated by
Year End --
FOSTER CITY, Calif. -- June 15, 2014
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from a
Phase 3 clinical trial (GS-US-337-0113) in Japan evaluating the
investigational once-daily fixed-dose combination of the NS5A inhibitor
ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor
sofosbuvir (SOF) 400 mg, with and without ribavirin (RBV), for the treatment
of genotype 1 chronic hepatitis C virus (HCV) infection. Among patients
receiving 12 weeks of LDV/SOF without RBV, 100 percent (n=83/83) of
treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients
achieved a sustained virologic response 12 weeks after completing therapy
(SVR12). Among patients receiving LDV/SOF plus RBV, 96 percent (n=80/83) of
treatment-naïve and 100 percent of treatment-experienced patients (n=87/87)
achieved SVR12. Across all arms of the study, patients with cirrhosis achieved
a 99 percent (n=75/76) SVR12. The study met its primary endpoint of
superiority compared to a predefined historical SVR12 rate. Patients who
achieve SVR12 are considered cured of HCV infection.
Genotype 1 is the most common strain of HCV in Japan, accounting for
approximately 70 percent of the more than one million people chronically
infected with the disease. The majority of these infections are due to HCV
genotype 1b. Current treatment options for genotype 1 HCV infection involve up
to 48 weeks of therapy with pegylated interferon injections, RBV tablets and
other oral medicines, which may not be suitable for certain patients.
“The cure rates observed with LDV/SOF in this study are impressive because
they were achieved without the need for interferon or ribavirin, both of which
involve more complex dosing requirements and may be associated with
significant side effects,” said Norbert Bischofberger, PhD, Gilead’s Executive
Vice President of Research and Development and Chief Scientific Officer.
“These results suggest that a once-daily LDV/SOF tablet has the potential to
be an efficacious and well-tolerated regimen for many HCV patients in Japan.”
In the study, 341 patients with genotype 1 HCV infection were randomized (1:1)
to receive 12 weeks of all-oral therapy with LDV/SOF, with or without RBV. Of
these, 166 patients were treatment-naïve, 175 were treatment-experienced and
76 had compensated cirrhosis. The intent-to-treat SVR12 rates in the study are
summarized in the table below:
Population Treatment Duration SVR12 Rates
Genotype 1 treatment-naïve LDV/SOF 12 weeks 100% (83/83)
LDV/SOF + RBV 12 weeks 96% (80/83)
Genotype 1 treatment-experienced LDV/SOF 12 weeks 100% (88/88)
LDV/SOF + RBV 12 weeks 100% (87/87)
Overall, 338/341 patients (99 percent) in Study GS-US-337-0113 achieved SVR12.
Of the three patients who failed to achieve SVR12, one patient relapsed after
discontinuation of therapy, one patient discontinued therapy after one week of
treatment due to rash and one patient died during the study.
Fewer adverse events were observed in the RBV-free arms compared to the
RBV-containing arms in the study, most notably with regard to anemia, which
was observed in 14 percent of patients taking LDV/SOF plus RBV compared to 2
percent of patients receiving LDV/SOF alone. Adverse events observed with
LDV/SOF without RBV were generally mild and included nasopharyngitis (28
percent), headache (6 percent) and malaise (5 percent). Among those taking
LDV/SOF plus RBV, in addition to anemia, the most common adverse events were
nasopharyngitis (22 percent), pruritus (8 percent), rash (8 percent), headache
(8 percent), stomatitis (6 percent), nausea (5 percent) and malaise (5
percent). No patients taking LDV/SOF and two patients taking LDV/SOF plus RBV
discontinued treatment due to treatment-emergent adverse events. Full study
results will be presented at a future scientific meeting.
Based on these data, Gilead plans to submit a New Drug Application for the
LDV/SOF fixed-dose combination with the Japanese Pharmaceutical and Medical
Devices Agency (PMDA) by the end of 2014. The product is currently under
regulatory review in the United States and European Union.
On April 2, 2014, Gilead announced topline results from another Phase 3 study
in Japan evaluating SOF as a single agent in combination with RBV for the
treatment of genotype 2 HCV infection. The company plans to file for approval
of SOF with the PMDA by mid-2014. SOF as a single agent has been approved by
regulatory authorities in the United States, European Union and Canada under
the tradename Sovaldi^®.
LDV/SOF and SOF are investigational products in Japan and their 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 and South America, Europe and Asia 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 SOF or the
LDV/SOF fixed-dose combination in Japan and the possibility that the company
may not file for regulatory approval of SOF as a single agent or the LDV/SOF
fixed-dose combination in Japan in the currently anticipated timelines.
Further, the PDMA and regulatory authorities in the United States and the
European Union may not approve the LDV/SOF fixed-dose combination and the PMDA
may not approve SOF as a standalone agent in Japan, and any marketing
approvals, if granted, may have significant limitations on their 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 Quarterly Report on Form 10-Q
for the quarter ended March 31, 2014, 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.
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 (@GileadSciences) or call Gilead
Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Cara Miller, 650-522-1616
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