-- Full Results from Four Phase 3 ASTRAL Studies of
Sofosbuvir/Velpatasvir to be Presented --
Gilead Sciences, Inc. (NASDAQ:GILD) today announced it will present 32
scientific presentations related to its approved medicines and
investigational therapies for the treatment of chronic hepatitis C virus
(HCV) infection at The Liver Meeting 2015 in San Francisco. Data include
results from studies of Harvoni® (ledipasvir/sofosbuvir) and
Sovaldi® (sofosbuvir) that advance the understanding of the
profiles of these drugs in several patient populations. Detailed results
from the four Phase 3 ASTRAL studies evaluating the company’s next
potential single tablet regimen – a once-daily combination of
velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, with
sofosbuvir (SOF) – also will be presented.
“We continue to advance our understanding of the safety and efficacy of
Sovaldi and Harvoni in diverse groups of HCV patients, including several
special patient populations that historically have not been studied,”
said Norbert Bischofberger, PhD, Executive Vice President of Research
and Development and Chief Scientific Officer at Gilead. “We are also
pleased to share data evaluating our next-generation investigational
sofosbuvir-based therapies SOF/VEL and SOF/VEL plus GS-9857. In total,
the data highlighted this week demonstrate the strength of sofosbuvir as
the backbone of multiple hepatitis C treatment regimens in numerous
hepatitis C-infected patient populations.”
Harvoni
Harvoni is the first single tablet regimen for the treatment of chronic
HCV genotype 1. Following the U.S. Food and Drug Administration’s
approval of Gilead’s supplemental new drug application on November 12,
2015, Harvoni is now also indicated for genotypes 4, 5 and 6. Data
presented this week demonstrate the efficacy and safety profile of
Harvoni in populations with unmet medical needs including pre- and
post-liver transplant patients with decompensated cirrhosis (Posters
#1130, #1045, #1049). In addition, Oral #96 describes a review of safety
data from the SOLAR-1 and SOLAR-2 studies that suggest a new algorithm
for the detection of potential drug-induced liver injury in patients
with decompensated cirrhosis receiving direct acting antiviral-based
regimens. A new analysis and an additional study describe the efficacy
and safety of Harvoni in Asian patients (Poster #1105) and in patients
with hereditary bleeding disorders (Poster #1034).
Sovaldi
Results and new analyses from several studies highlighting the utility
of Sovaldi in combination with other agents in several diverse and
newly-studied populations, including Asian patients (Poster #1080) and
those with severe renal impairment (Poster #1128) also will be presented
this week. Sovaldi is approved in combination with other agents for the
treatment of genotypes 1-4 chronic HCV infection.
Hepatitis C Pipeline
Detailed results from Gilead’s four Phase 3 ASTRAL studies of SOF/VEL in
patients with genotype 1-6 chronic HCV infection, ASTRAL-1 (Oral LB-2),
ASTRAL-2 (Oral #205), ASTRAL-3 (Oral #249) and ASTRAL-4 (Poster LB-13),
will be presented at various times throughout The Liver Meeting 2015.
Based on these data, Gilead submitted a new drug application (NDA) for
SOF/VEL to the FDA on October 28, 2015. The company plans to submit a
regulatory application for approval of SOF/VEL in the European Union by
the end of the year. If approved, SOF/VEL would be Gilead’s third HCV
medication and the first all-oral, pan-genotypic, single tablet HCV
regimen.
Gilead also will present new data from a study evaluating the safety and
efficacy of the combination of SOF/VEL with GS-9857, an investigational
pangenotypic NS3/4A protease inhibitor, in patients with HCV genotype 1
and 3 infection (Oral #38). Based on these data, SOF, VEL and GS-9857
co-formulated into a fixed-dose combination will be advanced into Phase
3 studies.
Abstracts for Gilead’s presentations can be accessed at http://www.aasld.org/sites/default/files/2015SupplementFULLTEXT.pdf.
Further information about the clinical studies described above can be
found at www.clinicaltrials.gov.
Uses in certain HCV patient populations highlighted above for Harvoni
and Sovaldi are investigational and have not been determined to be safe
or efficacious. SOF/VEL and SOF/VEL/GS-9857 are investigational products
and have not been determined to be safe or efficacious.
Important Safety Information About Harvoni
Contraindications
If Harvoni is used in combination with ribavirin (RBV), all
contraindications, warnings and precautions, in particular pregnancy
avoidance, and adverse reactions to RBV also apply. Refer to RBV
prescribing information.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Coadministered with
Amiodarone: Amiodarone is not recommended for use with Harvoni due
to the risk of symptomatic bradycardia, particularly in patients also
taking beta blockers or with underlying cardiac comorbidities and/or
with advanced liver disease. In patients without alternative, viable
treatment options, cardiac monitoring is recommended. Patients should
seek immediate medical evaluation if they develop signs or symptoms of
bradycardia.
Risk of Reduced Therapeutic Effect of Harvoni Due
to P-gp Inducers: Rifampin and St. John’s wort are not recommended
for use with Harvoni as they may significantly decrease ledipasvir and
sofosbuvir plasma concentrations.
Related Products Not Recommended: Harvoni is not recommended for
use with other products containing sofosbuvir (Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue, headache
and asthenia.
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Harvoni
is also not recommended with carbamazepine, oxcarbazepine,
phenobarbital, phenytoin, rifabutin, rifapentine, and
tipranavir/ritonavir. Such coadministration is expected to decrease the
concentration of ledipasvir and sofosbuvir, reducing the therapeutic
effect of Harvoni.
Coadministration of Harvoni is not recommended with simeprevir due to
increased concentrations of ledipasvir and simeprevir. Coadministration
is also not recommended with rosuvastatin or co-formulated
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due
to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni for more
information on potentially significant drug interactions, including
clinical comments.
Important Safety Information About Sovaldi
Contraindications
Contraindications to peginterferon alfa and ribavirin also apply to
SOVALDI combination treatment. Refer to the prescribing information of
peginterferon alfa and ribavirin for a list of their contraindications.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Coadministered with
Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone
is not recommended for use with Sovaldi in combination with another DAA
due to the risk of symptomatic bradycardia, particularly in patients
also taking beta blockers or with underlying cardiac comorbidities
and/or with advanced liver disease. In patients without alternative,
viable treatment options, cardiac monitoring is recommended. Patients
should seek immediate medical evaluation if they develop signs or
symptoms of bradycardia.
Risk of Reduced Therapeutic Effect of Sovaldi Due to Use with P-gp
Inducers: Rifampin and St. John’s wort are not recommended for use
with Sovaldi as they may significantly decrease sofosbuvir plasma
concentrations.
Risk Associated with Combination Treatment: Because Sovaldi is
used in combination with other antiviral drugs for the treatment of HCV
infection, consult the Prescribing Information for these drugs.
Related Products Not Recommended: Sovaldi is not recommended for
use with other products containing sofosbuvir.
Adverse Reactions
Most common (≥20%, all grades) adverse reactions for:
-
Sovaldi + peginterferon alfa + ribavirin combination therapy were
fatigue, headache, nausea, insomnia, and anemia
-
Sovaldi + ribavirin combination therapy were fatigue and headache
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Sovaldi
is not recommended with carbamazepine, oxcarbazepine,
phenobarbital, phenytoin, rifabutin, rifapentine, and
tipranavir/ritonavir. Such coadministration is expected to decrease the
concentration of sofosbuvir, reducing its therapeutic effect.
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. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.
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
possibility of unfavorable results from these studies and other ongoing
and subsequent clinical trials involving Harvoni, Sovaldi, SOF/VEL and
SOF/VEL with GS-9857. The FDA may not approve the SOF/VEL fixed-dose
combination, and any marketing approvals, if granted, may have
significant limitations on its use. In addition, Gilead may be unable to
file for regulatory approval of SOF/VEL in other geographies in the
currently anticipated timelines. As a result, Gilead may not be able to
successfully commercialize SOF/VEL. 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 September 30, 2015, 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 and Harvoni is
available at www.gilead.com.
Sovaldi and Harvoni are registered trademarks of Gilead Sciences,
Inc. or its related companies.
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.
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