-- High Cure Rates Observed Across a Range
of Genotypes --
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.
Gilead Sciences, Inc.Sung Lee, +1 650-524-7792 (Investors)Nathan
Kaiser, +1 650-522-1853 (Media)Michele Rest, +1 650-577-6935
(Media)
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