-- More Than 50 Abstracts Across NASH, PSC,
HBV and HCV Reflect Ongoing Commitment to Advancing the Care of
People with Liver Disease--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that data
from the company’s liver disease research and development programs
in nonalcoholic steatohepatitis (NASH), primary sclerosing
cholangitis (PSC), hepatitis B virus (HBV) infection and hepatitis
C virus (HCV) infection will be presented at The Liver Meeting®
2018 in San Francisco from November 9-13, 2018. The data reflect
Gilead’s ongoing commitment to advancing the care of patients with
serious liver diseases.
“Gilead has transformed the treatment of viral liver diseases
with innovative medicines that have cured HCV and significantly
improved treatment of HBV for millions around the world,” said John
McHutchison, AO, MD, Chief Scientific Officer, Head of Research
& Development, Gilead Sciences. “Today, we are working to bring
this expertise and commitment to other serious liver diseases with
significant unmet medical needs, such as advanced fibrosis due to
NASH and PSC – two diseases with no or limited treatment
options.”
Advanced Fibrosis due to
NASH
Individuals with advanced fibrosis, defined as bridging fibrosis
(F3) or cirrhosis (F4), are at a significantly higher risk of
liver-related mortality. Gilead is advancing multiple
investigational compounds for the treatment of advanced fibrosis
due to NASH. Data being presented at the meeting further elucidate
the potential role and safety profile of three compounds in
development.
- The non-steroidal FXR agonist GS-9674
leads to significant reductions in hepatic steatosis, serum bile
acids, and liver biochemistry in a Phase 2, randomized,
placebo-controlled trial of patients with NASH (poster #0736)
- Hepatic metabolomics and plasma
microRNA analysis of combinations of an ASK1 inhibitor, an ACC
inhibitor, and an FXR agonist in the rat choline-deficient high fat
diet model reveal reductions in oxidative stress, inflammation and
fibrosis (poster #1265)
Currently, liver biopsy is the standard method to diagnose
advanced fibrosis due to NASH. This invasive and costly procedure
presents challenges to appropriate diagnosis and treatment. Data
being presented at The Liver Meeting describe the potential role
and sequence of noninvasive tests in the diagnosis of advanced
fibrosis due to NASH and patient-reported outcomes from two global
Phase 3 trials evaluating the investigational ASK1 inhibitor
selonsertib.
- Algorithms using noninvasive tests can
accurately identify patients with advanced fibrosis due to NASH:
Data from STELLAR clinical trials (late-breaking poster
#LB-10)
- Routinely available noninvasive tests
discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR
trials of the ASK1 inhibitor selonsertib (poster #1674)
- Severe impairment of patient-reported
outcomes in patients with advanced fibrosis due to NASH (poster
#1683)
- Advanced fibrosis based on noninvasive
tests in NASH is associated with impairment of patient-reported
outcomes (poster #1991)
PSC
Data will be presented from a Phase 2 trial evaluating the
investigational non-steroidal farnesoid X receptor (FXR) agonist
GS-9674 in PSC. PSC is a rare and chronic condition that causes
inflammation and scarring of the bile ducts, which can lead to
liver failure. There are limited treatment options currently
available for patients with PSC.
- The non-steroidal FXR agonist GS-9674
improves liver biochemistry and decreases serum bile acids in
patients with PSC: A Phase 2, randomized, placebo-controlled trial
(oral presentation #0043)
HBV Functional Cure
Data will also be presented from Gilead’s ongoing program
directed at achieving a functional cure for HBV by maintaining
viral suppression without ongoing therapy. GS-9688, an
investigational oral selective toll-like receptor 8 (TLR8) agonist,
is the subject of several studies to be presented, including
first-in-human clinical results and Phase 1b results from
evaluation in patients with chronic hepatitis B.
- First in human study of GS-9688, an
oral Toll-like Receptor 8 (TLR8) agonist, in healthy volunteers:
assessment of safety, tolerability, pharmacokinetics,
pharmacodynamics and food effect (poster #0390)
- Pharmacodynamic response to oral
administration of the selective toll-like receptor 8 agonist
GS-9688 in healthy volunteers (poster #0456)
- Safety, pharmacokinetics and
pharmacodynamics of oral TLR8 agonist GS-9688 in patients with
chronic hepatitis B: a randomized, placebo-controlled, double-blind
Phase 1b study (poster #0401)
GS-9674, selonsertib and GS-9688 are investigational compounds
and are not approved by the U.S. Food and Drug Administration (FDA)
or any other regulatory authority. Their safety and efficacy have
not been established.
Viral Hepatitis
Treatment
Viral hepatitis presentations include studies of Epclusa®
(sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir
90mg/sofosbuvir 400mg) in difficult to cure HCV populations and
data demonstrating the role of Vemlidy® (tenofovir alafenamide
25mg, TAF) in the management of chronic hepatitis B.
- Sofosbuvir/velpatasvir for 12 weeks is
safe and effective in patients undergoing dialysis (late-breaking
poster #LB-15)
- Ledipasvir/sofosbuvir for 12 weeks is
safe and effective in children 3 to <6 years old with chronic
HCV infection (oral presentation #0184)
- Three year efficacy and safety of TAF
compared to tenofovir disoproxil fumarate (TDF) in HBeAg-negative
and HBeAg-positive patients with chronic hepatitis B (poster
#0404)
- Safety and efficacy at 1 year in post
liver transplant patients with chronic kidney disease receiving
tenofovir alafenamide for HBV prophylaxis (poster #1225)
EPCLUSA and HARVONI are each indicated in the U.S. for the
treatment of chronic HCV infection in patients with no cirrhosis or
compensated cirrhosis: EPCLUSA for adults with genotypes 1-6; and
HARVONI for patients 12 years and older with genotypes 1, 4, 5 and
6. VEMLIDY is indicated for the treatment of chronic HBV infection
in adults with compensated liver disease. The US product labels for
EPCLUSA, HARVONI, and VEMLIDY each contain a BOXED WARNING: for
EPCLUSA and HARVONI, the risk of hepatitis B reactivation in
HCV/HBV co-infected patients; and for VEMLIDY, the risk of
post-treatment acute exacerbation of HBV. See below for U.S.
Important Safety Information.
The safety and efficacy of EPCLUSA in HCV patients undergoing
dialysis and HARVONI in HCV patients ages 3 to up to 6 years of age
have not been established.
For more information, including a complete list of abstract
titles at the meeting, please visit:
http://www.aasld.org/events-professional-development/liver-meeting.
US Important Safety Information and
Indications for Harvoni and Epclusa
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN
HCV/HBV COINFECTED PATIENTS
Test all patients for evidence of current or prior hepatitis
B virus (HBV) infection before initiating treatment with HARVONI or
EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected
patients who were undergoing or had completed treatment with HCV
direct acting antivirals (DAAs) and were not receiving HBV
antiviral therapy. Some cases have resulted in fulminant hepatitis,
hepatic failure, and death. Cases have been reported in patients
who are HBsAg positive, in patients with serologic evidence of
resolved HBV, and also in patients receiving certain
immunosuppressant or chemotherapeutic agents; the risk of HBV
reactivation associated with treatment with HCV DAAs may be
increased in patients taking these other agents. Monitor HCV/HBV
coinfected patients for hepatitis flare or HBV reactivation during
HCV treatment and post-treatment follow-up. Initiate appropriate
patient management for HBV infection as clinically
indicated.
Contraindications
If HARVONI or EPCLUSA 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
Serious Symptomatic Bradycardia When Coadministered with
Amiodarone: Amiodarone is not recommended for use with HARVONI
or EPCLUSA 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. A fatal cardiac
arrest was reported in a patient taking amiodarone who was
coadministered a sofosbuvir containing regimen. 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 Due to Use with P-gp
Inducers and/or Moderate to Potent Inducers of CYP: Rifampin,
St. John’s wort and carbamazepine are not recommended for use with
HARVONI or with EPCLUSA. P-gp inducers may significantly decrease
ledipasvir, sofosbuvir and/or velpatasvir plasma concentrations.
Moderate to potent inducers of CYP2B6, CYP2C8 or CYP3A4 may
significantly decrease sofosbuvir and/or velpatasvir plasma
concentrations.
Adverse Reactions
The most common adverse reactions (≥10%, all grades) with
HARVONI were fatigue, headache, and asthenia.
The most common adverse reactions (≥10%, all grades) with
EPCLUSA were headache and fatigue; and when used with RBV in
decompensated cirrhotics were fatigue, anemia, nausea, headache,
insomnia, and diarrhea.
Drug Interactions
HARVONI: Coadministration is not recommended with
oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine,
and tipranavir/ritonavir due to decreased concentrations of
ledipasvir and sofosbuvir; or with co-formulated
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
due to increased concentrations of tenofovir; or with simeprevir
due to increased concentrations of ledipasvir and simeprevir; or
with rosuvastatin due to increased concentrations of
rosuvastatin.
EPCLUSA: Coadministration is not recommended with
topotecan due to increased concentrations of topotecan; or with
proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin,
rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to
decreased concentrations of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for HARVONI and EPCLUSA
for more information on potentially significant drug interactions,
including clinical comments.
INDICATION for HARVONI
HARVONI is indicated for the treatment of adults with chronic
hepatitis C virus genotype (GT) 1, 4, 5, or 6 infection without
cirrhosis or with compensated cirrhosis. HARVONI is used with
ribavirin in GT 1 adults with decompensated cirrhosis and in GT 1
or 4 adult liver transplant recipients without cirrhosis or with
compensated cirrhosis.
INDICATION for EPCLUSA
EPCLUSA is indicated for the treatment of adults with chronic
hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without
cirrhosis or with compensated cirrhosis and in combination with
ribavirin for those with decompensated cirrhosis.
US Important Safety Information and
Indications for Vemlidy
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF
HEPATITIS B
Discontinuation of anti-hepatitis B therapy, including
VEMLIDY, may result in severe acute exacerbations of hepatitis B.
Hepatic function should be monitored closely with both clinical and
laboratory follow-up for at least several months in patients who
discontinue anti-hepatitis B therapy, including VEMLIDY. If
appropriate, resumption of anti-hepatitis B therapy may be
warranted.
Warnings and Precautions
Risk of Development of HIV-1 Resistance in HBV/HIV-1
Coinfected Patients: Due to this risk, VEMLIDY alone should not
be used for the treatment of HIV-1 infection. Safety and efficacy
of VEMLIDY have not been established in HBV/HIV-1 coinfected
patients. HIV antibody testing should be offered to all
HBV-infected patients before initiating therapy with VEMLIDY, and,
if positive, an appropriate antiretroviral combination regimen that
is recommended for HBV/HIV-1 coinfected patients should be
used.
New Onset or Worsening Renal Impairment: Cases of acute
renal failure and Fanconi syndrome have been reported with the use
of tenofovir prodrugs. In clinical trials of VEMLIDY, there have
been no cases of Fanconi syndrome or proximal renal tubulopathy
(PRT). Patients with impaired renal function and/or taking
nephrotoxic agents (including NSAIDs) are at increased risk of
renal-related adverse reactions. Discontinue VEMLIDY in patients
who develop clinically significant decreases in renal function or
evidence of Fanconi syndrome. Monitor renal function in all
patients – See Dosage and Administration.
Lactic Acidosis and Severe Hepatomegaly with Steatosis:
Fatal cases have been reported with the use of nucleoside analogs,
including tenofovir disoproxil fumarate. Discontinue VEMLIDY if
clinical or laboratory findings suggestive of lactic acidosis or
pronounced hepatotoxicity develop, including hepatomegaly and
steatosis in the absence of marked transaminase elevations.
Adverse Reactions
Most common adverse reactions (incidence ≥5%; all grades) were
headache, abdominal pain, cough, back pain, fatigue, nausea,
arthralgia, diarrhea, and dyspepsia.
Drug Interactions
Coadministration of VEMLIDY with drugs that reduce renal
function or compete for active tubular secretion may increase
concentrations of tenofovir and the risk of adverse reactions.
Coadministration of VEMLIDY is not recommended with the
following: oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifampin, rifapentine, or St. John’s wort. Such coadministration is
expected to decrease the concentration of tenofovir alafenamide,
reducing the therapeutic effect of VEMLIDY. Drugs that strongly
affect P-glycoprotein (P-gp) and breast cancer resistance protein
(BCRP) activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more
information on potentially significant drug interactions, including
clinical comments.
Dosage and Administration
Dosage: Adults; 1 tablet taken once daily with food.
Renal Impairment, Screening, and Monitoring: VEMLIDY is
not recommended in patients with CrCl <15 mL/min. In all
patients, assess serum creatinine, estimated creatinine clearance,
urine glucose, and urine protein prior to initiating and during
treatment, on a clinically appropriate schedule. In patients with
chronic kidney disease, also assess serum phosphorus.
Hepatic Impairment: Not recommended in patients with
decompensated (Child-Pugh B or C) hepatic impairment.
Testing Prior to Initiation: HIV infection.
INDICATION
VEMLIDY is indicated for the treatment of chronic hepatitis B
virus infection in adults with compensated liver disease.
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 35 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 ongoing and
additional clinical trials involving GS-9674, selonsertib and
GS-9688. Further, it is possible that the parties may make a
strategic decision to discontinue development of GS-9674,
selonsertib and GS-9688, and as a result, these compounds may never
be successfully commercialized. 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 June 30, 2018, 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 Epclusa,
Harvoni and Vemlidy including BOXED WARNINGS, are available
at www.gilead.com.
Epclusa, Harvoni and Vemlidy 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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