-- High Cure Rates Observed Across a Range of Genotypes --
Company Website:
http://www.gilead.com
VIENNA, Austria -- (Business Wire)
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from two
studies evaluating the safety and efficacy of investigational uses of
sofosbuvir-based regimens in chronic hepatitis C virus (HCV)-infected
patients with genotypes 2, 3, 4 and 5. Results from the BOSON study of
Sovaldi® (sofosbuvir 400 mg) in combination with ribavirin
(RBV) or with pegylated interferon (PEG)/RBV demonstrated high cure
rates across all patients with genotypes 2 and 3. Separately, results
from a Phase 2 study demonstrate the safety and efficacy of Harvoni®
(ledipasvir 90 mg/sofosbuvir 400 mg) in patients with genotypes 4 or 5
infection. Data from both studies will be presented in oral sessions at
the 50th Annual Meeting of the European Association for the Study of the
Liver (The International Liver Congress™ 2015) in Vienna, Austria.
Sovaldi and Harvoni are each approved in the United States for the
treatment of chronic HCV infection. Sovaldi is used in combination with
other agents and its efficacy has been established in patients with
genotypes 1-4; Harvoni is indicated for patients with genotype 1.
BOSON (Study GS-US-334-0153, #LB05), a randomized Phase 3 study of 592
patients, evaluated the safety and efficacy of Sovaldi plus RBV for 16
or 24 weeks compared with Sovaldi plus PEG/RBV for 12 weeks among
treatment-naïve or treatment-experienced genotype 3 patients with and
without cirrhosis and treatment-experienced genotype 2 patients with
cirrhosis. Thirty-seven percent of study participants had cirrhosis.
Among genotype 3 patients, rates of sustained virologic response 12
weeks after treatment (SVR12) were highest among those receiving Sovaldi
plus PEG/RBV for 12 weeks (93 percent, n=168/181), compared to those
receiving Sovaldi plus RBV for 24 weeks (84 percent, n=153/182) or for
16 weeks (71 percent, n=128/181). Treatment-experienced genotype 3
patients with cirrhosis receiving Sovaldi plus PEG/RBV demonstrated
SVR12 rates of 86 percent (30/35).
Genotype 2 patients also demonstrated high SVR12 rates across all
treatment arms. SVR12 rates among patients receiving Sovaldi plus
PEG/RBV were 94 percent (15/16), and 100 percent (17/17) and 87 percent
(13/15) for those receiving Sovaldi plus RBV for 24 and 16 weeks,
respectively.
Sovaldi plus PEG/RBV and Sovaldi plus RBV were well tolerated. The most
common adverse events in the study were fatigue, headache, insomnia and
nausea. Overall, six patients (1 percent) discontinued treatment due to
adverse events, one of whom was treated with Sovaldi plus PEG/RBV.
“It remains difficult to achieve a virological response in genotype 3,
which is one of the most prevalent genotypes in the world, with higher
prevalence in Europe and Asia,” said Graham R. Foster, FRCP, PhD,
Professor of Hepatology, The Liver Unit, Queen Mary's University of
London, Barts Health, London, United Kingdom. “These results are
compelling because they represent the highest cure rates observed among
treatment-experienced, cirrhotic genotype 3 patients in any Phase 3
clinical trial to date.”
In a separate open-label Phase 2 study of Harvoni conducted in France
(Study GS-US-337-1119, O056), results demonstrated high SVR rates in
both treatment-naïve and treatment-experienced patients with chronic HCV
genotypes 4 or 5 infection, 50 percent of whom had cirrhosis.
Ninety-three percent of patients with genotype 4 (41/44) and 95 percent
of patients with genotype 5 (39/41) achieved SVR12. Response rates were
similar among both treatment-naïve and -experienced patients and
regardless of cirrhosis.
The most common adverse events (affecting more than 10 percent of
patients) were asthenia, headache and fatigue. Most adverse events were
mild or moderate in severity and none resulted in treatment
discontinuation. There were no grade 3 or 4 clinical laboratory
abnormalities.
“HCV genotype 4 and 5 are less prevalent than other genotypes and
therefore, have traditionally not been closely studied,” said Armand
Abergel, MD, PhD, Department of Hepatology and Gastroenterology, Centre
Hospitalier Universitaire-Estaing, Université d'Auvergne,
Clermont-Ferrand, France. “These data provide important evidence that
the all-oral, ribavirin-free Harvoni regimen is both safe and effective
for many patients with genotype 4 or 5, regardless of prior treatment
experience.”
The safety and efficacy of these investigational uses of Harvoni and
Sovaldi have not been established.
Important Safety Information About Sovaldi
Contraindications
Sovaldi combination treatment with ribavirin or with peginterferon alfa
plus ribavirin is contraindicated in women who are pregnant or may
become pregnant and men whose female partners are pregnant because of
the risk for birth defects and fetal death associated with ribavirin.
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
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.
Pregnancy: Use with ribavirin or peginterferon alfa/ribavirin:
Ribavirin therapy should not be started unless a report of a negative
pregnancy test has been obtained immediately prior to initiation of
therapy. Female patients of childbearing potential and their male
partners must use two forms of non-hormonal contraception during
treatment and for at least 6 months after treatment has concluded.
Routine monthly pregnancy tests must be performed during this time.
Refer to the prescribing information for ribavirin.
Use with Potent P-gp Inducers: Rifampin and St. John’s wort
should not be used with Sovaldi as they may significantly decrease
sofosbuvir plasma concentration, reducing its therapeutic effect.
Adverse Reactions
Most common (≥20 percent, 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.
Important Safety Information About Harvoni
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 percent, all grades) adverse reactions were fatigue and
headache.
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.
About Gilead
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 risk
that Gilead may observe unfavorable results from additional clinical
trials involving Sovaldi and Harvoni for various patient populations,
including those with genotype 2, 3, 4 and 5 HCV. 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, 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 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.
Contacts:
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792 (Investors)
Nathan
Kaiser, +1 650-522-1853 (Media)
Michele Rest, +1 650-577-6935
(Media)
Source: Gilead Sciences, Inc.
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