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-- Data Support Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose
Combination with Ribavirin in Genotype 3 HCV; Product Under Regulatory
Review for Genotype 1 in U.S., Europe --
-- Combination of Sofosbuvir and GS-5816 Demonstrates Efficacy
Against HCV Genotypes 1-6 --
LONDON--(BUSINESS WIRE)--Apr. 10, 2014--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase
2 studies evaluating investigational all-oral regimens containing the
nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the
treatment of chronic hepatitis C virus (HCV) infection. These data are
being presented this week at the 49th Annual Meeting of the European
Association for the Study of the Liver (The International Liver Congress
2014) in London.
The first study, ELECTRON2 (Oral #6), is an ongoing, open-label Phase 2
clinical trial evaluating a once-daily fixed-dose combination of SOF 400
mg and the NS5A inhibitor ledipasvir (LDV) 90 mg, with and without
ribavirin (RBV) twice-daily (1,000 or 1,200 mg/day), among HCV-infected
In this study, 100 percent (n=26/26) of treatment-naïve genotype 3
patients receiving 12 weeks of LDV/SOF plus RBV and 64 percent (n=16/25)
of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF
without RBV achieved a sustained virologic response 12 weeks after
completing therapy (SVR12). Among genotype 1-infected patients who had
failed prior treatment with SOF plus RBV, 100 percent (19/19) achieved
SVR12 following 12 weeks of LDV/SOF plus RBV. Additionally, 65 percent
(n=13/20) of genotype 1-infected patients with decompensated or
Child-Turcotte-Pugh Class B cirrhosis receiving 12 weeks of LDV/SOF
without RBV achieved SVR12. LDV/SOF with and without RBV was
well-tolerated, including among patients with more advanced liver
“The ELECTRON2 data suggest that an all-oral regimen of LDV/SOF plus RBV
has the potential to provide high cure rates for genotype 3 patients in
just 12 weeks – half the duration of current all-oral treatment
regimens,” said Professor Edward Gane, MD, Deputy Director and
Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital
in New Zealand, and principal investigator of the ELECTRON2 study.
“These results also suggest that LDV/SOF may be an effective treatment
regimen for HCV genotype 1-infected patients who have failed a previous
sofosbuvir-based regimen and those with advanced liver disease,
including decompensated cirrhosis.”
A second study, Study GS-US-342-0102 (Oral #111), is an ongoing
randomized Phase 2 clinical trial in which treatment-naïve,
non-cirrhotic patients with genotypes 1-6 HCV infection received a
12-week course of SOF plus the pan-genotypic NS5A inhibitor GS-5816.
Patients received SOF 400 mg and either GS-5816 25 mg (n=77) or GS-5816
100 mg (n=77). In this study, 94.8 percent (n=73/77) of patients
receiving the 25 mg dose of GS-5816 and 96.1 percent (n=74/77) of
patients receiving the 100 mg dose achieved SVR12.
“The results of this study of sofosbuvir with a new pan-genotype NS5A
inhibitor demonstrate the curative potential of this combination,” said
Gregory T. Everson, MD, Professor of Medicine and Director, Section of
Hepatology, University of Colorado, Denver, and principal investigator
of Study GS-US-342-0102. “The combination was not only effective across
all genotypes and patient subgroups, but also was well tolerated. These
results warrant additional study in future trials, with the hope of
providing a potent, pan-genotypic combination with few side effects and
a high chance for cure.”
The most common adverse events occurring in more than 10 percent of
patients were fatigue, headache and nausea. There were no treatment
discontinuations due to adverse events, and no evidence of
treatment-related laboratory abnormalities.
Additional information about ELECTRON2 and GS-US-342-102 can be found at www.clinicaltrials.gov.
About SOF-Based Fixed-Dose Combinations
Full data from three Phase 3 clinical trials of the LDV/SOF fixed-dose
combination (ION-1, ION-2 and ION-3) are also being presented at The
International Liver Congress 2014. Gilead announced topline results from
the ION studies on December 18, 2013. On February 10, 2014, Gilead
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for the LDV/SOF fixed-dose combination tablet for
the treatment of genotype 1 HCV infection in adults. The FDA has
assigned the product a Breakthrough Therapy designation, which is
granted to investigational medicines that may offer major advances in
treatment over existing options. On April 7, 2014, the company announced
that the FDA has granted the application a priority review, setting a
target action date under the Prescription Drug User Fee Act (PDUFA) of
October 10, 2014.
On March 27, 2014, the European Medicines Agency (EMA) accepted Gilead’s
request for accelerated assessment for LDV/SOF, a designation that is
granted to new medicines of major public health interest. Accelerated
assessment could shorten the EMA’s review time of LDV/SOF by two months,
although it does not guarantee a positive opinion from the Committee for
Medicinal Products for Human Use, or final approval by the European
Gilead has developed a once-daily fixed-dose combination tablet
containing SOF and GS-5816. A second Phase 2 clinical trial (Study
GS-US-342-0109) evaluating 12 weeks of SOF plus GS-5816, with or without
RBV, among treatment-experienced cirrhotic and non-cirrhotic patients
with genotypes 1 or 3 HCV infection is ongoing. Pending full results
from Studies GS-US-334-102 and GS-US-342-0109, Gilead plans to initiate
Phase 3 studies evaluating the efficacy and safety of the SOF/GS-5816
LDV/SOF and SOF/GS-5816 are investigational products and their safety
and efficacy have not yet been established.
SOF as a single agent is approved as Sovaldi® in the United
States, European Union, Canada, New Zealand and Switzerland.
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
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 the FDA, European Commission and other regulatory agencies may not
approve the LDV/SOF fixed-dose combination in the currently anticipated
timelines or at all, and that any marketing approvals, if granted, may
have significant limitations on its use. Further, additional clinical
studies of LDV/SOF, including subsequent results from ELECTRON2, may
produce unfavorable results. As a result, Gilead may not be able to
successfully commercialize LDV/SOF, and may make a strategic decision to
discontinue its development if, for example, the market for the product
fails to materialize as expected. Additional risks include the
possibility of unfavorable results from additional studies of
SOF/GS-5816 and the possibility that Gilead may make a strategic
decision to discontinue development of the fixed-dose combination of
SOF/GS-5816 if, for example, Gilead believes commercialization will be
difficult relative to other opportunities in its pipeline. 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 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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, +1 650-522-1936 (Investors)Cara
Miller, +1 650-522-1616 (Media (U.S.))Arran Attridge, +44 208 587
2477 (Media (Europe))