– Interim Phase 3 Data Evaluating
Hepcludex®, a First-in-Class Entry Inhibitor, Conditionally
Approved in the EU, for the Treatment of Chronic Hepatitis Delta
Virus will be Presented in Official Press Program –
– One Late-Breaking, Six Oral Presentations
and Posters across HDV, HCV, HBV, NASH and PSC Demonstrate the
Breadth of Gilead’s Commitment to People with Liver Disease
–
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that more
than 70 abstracts from the company’s liver disease programs will be
presented at The International Liver Congress™ 2021 (ILC) taking
place from June 23-26. The breadth of data reflects Gilead’s
continued commitment to liver disease, including the recent
expansion into chronic hepatitis delta virus (HDV), with Hepcludex®
(bulevertide) as the first-in-class treatment for people with HDV
conditionally approved in Europe. Gilead will also present clinical
and real-world data on global efforts to support the World Health
Organization’s goal of hepatitis C (HCV) elimination, the impact of
treatment in chronic hepatitis B infection (HBV) and ongoing
research in nonalcoholic steatohepatitis (NASH) and primary
sclerosing cholangitis (PSC).
“We’re excited to join the liver community at this year’s
International Liver Congress and in particular to share these Phase
3 data which reinforce the potential of Hepcludex for the treatment
of HDV, the most severe form of chronic viral hepatitis,” said
Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We
continue to strive to address some of the most substantial
challenges in liver diseases, and we look forward to leveraging our
expertise to transform the trajectory for people living with
HDV.”
Gilead will present interim data on Hepcludex for the treatment
of HDV from Phase 3 and Phase 2b clinical trials, which reinforce
the safety and efficacy data that was used for the European
Medicines Agency (EMA) conditional approval in 2020.
Interim results from the Phase 3 study (MYR301) evaluating the
efficacy of Hepcludex monotherapy at low and high doses will be
presented as a late-breaking poster presentation (LBP-2730) and
broadcast live as part of the ILC’s Official Press Program on June
24 at 9:00 am EDT/15:00 pm CET. Additionally, interim findings from
the Phase 2b study (MYR204) will be presented, evaluating the
safety and efficacy of Hepcludex monotherapy and in combination
with peginterferon alfa-2a. Hepcludex is not approved by the U.S.
Food and Drug Administration (FDA).
“HDV only occurs in people co-infected with HBV and leads to
more serious liver disease than HBV alone, complicating the
diagnosis and treatment journey for this patient population,” said
Tarik Asselah, Professor of Hepatology at Hôpital Beaujon, Clichy,
and at the University Paris, and Head of Viral Hepatitis Team at
INSERM UMR1149, France. “The data on bulevertide to be presented at
ILC provide significant progress and promise for people living with
chronic HDV, who have previously had very limited treatment options
and a poor prognosis.”
HCV Elimination Efforts
Gilead will present real-world data from HCV screening and
linkage to care initiatives which underscore the company’s
dedication to global HCV elimination efforts. Additional results
will be presented showcasing the potential of Epclusa® (400 mg
sofosbuvir/100 mg velpatasvir) in the test-and-treat strategy for
HCV management based on a simplified monitoring algorithm for
appropriate patients.
HBV Treatment and Functional Cure
Data on HBV will highlight the long-term results of switching to
Vemlidy® (tenofovir alafenamide 25 mg, TAF). Data will also be
presented on Gilead’s ongoing pursuit toward HBV functional
cure.
Select accepted abstracts being presented at the ILC
include:
Abstract
Abstract Title
HDV
OS-2717
Safety and efficacy of bulevirtide
monotherapy and in combination with Peginterferon alfa-2a in
patients with chronic hepatitis delta: 24 weeks interim data of
MYR204 Phase 2b study
LBP-2730
Bulevirtide monotherapy at low and high
dose in patients with chronic hepatitis delta: 24 weeks interim
data of the Phase 3 MYR301 study
PO-665
Transcriptomic analyses reveal variation
of liver inflammation across phases of chronic hepatitis B
infection
HCV
PO-377
Risk of multiple drug-drug interactions
(DDIs) in HCV patients receiving pangenotypic DAAs (pDAAs): A
complex drug interaction scenario first time evaluated in German
patients
PO-1431
Value assessment of sofosbuvir-based
regimens for (chronic) hepatitis C in Spain
PO-1426
A discrete choice experiment about
patients' and clinicians' preferences for the meet-test-treat
approach to HCV management
OS-199
Get Tested LeEDs: Clinical impact and
cost-effectiveness of opt-out emergency department testing for
bloodborne viruses (BBVs)
PO-1341
Active search to retrieve lost-to
follow-up HCV patients (RELINK-C strategy): health and economic
value
PO-2020
Good practice hepatitis C screening and
linkage to care initiatives at the SLTC Summit 2020: three out of
four diagnosed patients able to start direct-acting antiviral
treatment
HBV
PO-2338
Switching from TDF and/or other oral
antivirals to TAF in virally suppressed chronic hepatitis B
patients with hepatic impairment: 2 year data efficacy & safety
results from a Phase 2 study
PO-2395
Switching from TDF and/or other oral
antivirals to TAF in virally suppressed CHB patients with moderate
or severe renal impairment or ESRD on HD: 96 week efficacy &
safety results from a Phase 2 study
OS-2283
Long-term efficacy and safety of tenofovir
disoproxil fumarate (TDF) in children with chronic hepatitis B
(CHB): final results from a placebo-controlled trial
PO-2429
Safety and efficacy of oral TLR8 agonist,
selgantolimod, in viremic adult patients with chronic hepatitis
B
PO-2422
Safety, efficacy, & pharmacodynamic
(PD) activity of 12 weeks treatment with oral RIG-I agonist,
inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult
patients with chronic hepatitis B: a Phase 2 collaboration
study
PO-1309
Alanine aminotransferase flares and
seroclearance in chronic hepatitis B virus patients
OS-2225
Predictive immune biomarkers of persistent
HBV DNA suppression and low replicative state after treatment
discontinuation in CHB patients
NASH
OS-1611
AI-based histologic measurement of NASH
(AIM-NASH): A drug development tool for assessing clinical trial
endpoints
OS-1746
Cilofexor and firsocostat treatment is
associated with widespread changes in the hepatic transcriptome in
NASH patients with advanced fibrosis
PO-757
Fenofibrate is safe and mitigates
increases in serum triglycerides in NASH patients treated with the
combination of the ACC inhibitor firsocostat and the FXR agonist
cilofexor: A randomized trial
PO-756
Combination treatments including
semaglutide, cilofexor, and/or firsocostat lead to greater
improvements in the FibroScan-AST (FAST) score compared to
semaglutide alone in patients with non-alcoholic
steatohepatitis
PO-1714
Liver stiffness by vibration-controlled
transient elastography predicts disease progression in patients
with advanced fibrosis due to NASH
PO-1568
Longitudinal variability of noninvasive
tests of fibrosis: Implications for treatment response monitoring
in patients with NASH
PO-756
Combination treatments including
semaglutide, cilofexor, and/or firsocostat lead to greater
improvements in the FibroScan-AST (FAST) score compared to
semaglutide alone in patients with non-alcoholic
steatohepatitis
PO-1831
Combinations of an acetyl CoA carboxylase
inhibitor, FXR agonist and GLP-1R agonist inhibits fibrosis
progression in the rat choline-deficient, L-amino acid defined,
high-fat diet model of advanced fibrosis
PO-866
Comparing traditional machine learning and
deep learning models to Fibrosis-4 index in the prediction of
non-alcoholic fatty liver disease-associated liver fibrosis
PSC
PO-1644
A deep learning approach to analysis of
MRCP images predicts clinical events and progression to cirrhosis
in patients with primary sclerosing cholangitis
For more information, including a complete list of abstract
titles being presented at the meeting, please visit:
https://easl.eu/event/the-international-liver-congress-2021/scientific-programme/.
Hepcludex has been granted PRIority MEdicines (PRIME) scheme
eligibility by EMA for the treatment of HDV infection and
Breakthrough Therapy designation by the U.S. FDA. Bulevirtide is an
investigational agent in the U.S. and outside of the European
Economic Area; in these regions the safety and efficacy have not
been established.
Cilofexor, firsocostat, inarigivir and selgantolimod are
investigational compounds and are not approved by the FDA or any
other regulatory authority; their safety and efficacy have not been
established.
Please see below for the U.S. Indications and Important Safety
Information, including BOXED WARNINGS, for Epclusa and Vemlidy.
U.S. Important Safety Information for
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 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 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 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 Strong Inducers of CYP2B6, CYP2C8 or
CYP3A4: Rifampin, St. John’s wort and carbamazepine are not
recommended for use with EPCLUSA as they may significantly decrease
sofosbuvir and/or velpatasvir plasma concentrations.
Adverse Reactions
- The most common adverse reactions (≥10%, all grades) with
EPCLUSA in adults and pediatric patients 6 years of age and older
were headache and fatigue; and when used with RBV in adults with
decompensated cirrhosis were fatigue, anemia, nausea, headache,
insomnia and diarrhea. The most common adverse reactions (≥10%,
grade 1 or 2) in pediatric patients less than 6 years of age were
vomiting and spitting up the drug.
Drug Interactions
- Coadministration of EPCLUSA is not recommended with topotecan
due to increased concentrations of topotecan.
- Coadministration of EPCLUSA is not recommended with proton-pump
inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine,
efavirenz, and tipranavir/ritonavir due to decreased concentrations
of sofosbuvir and/or velpatasvir.
- Consult the full Prescribing Information for EPCLUSA for more
information on potentially significant drug interactions, including
clinical comments.
Indication
EPCLUSA is indicated for the treatment of adult and pediatric
patients 3 years of age and older 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.
U.S. Important Safety Information and
Indication 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 DF. 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
- Testing Prior to Initiation: HIV infection.
- Prior to or when initiating, and during treatment: On a
clinically appropriate schedule, assess serum creatinine, estimated
creatinine clearance, urine glucose, and urine protein in all
patients. In patients with chronic kidney disease, also assess
serum phosphorus.
- Dosage in Adults: 1 tablet taken once daily with
food.
- Renal Impairment: Not recommended in patients with end
stage renal disease (ESRD; eCrCl <15 mL/min) who are not
receiving chronic hemodialysis; in patients on chronic
hemodialysis, on hemodialysis days, administer VEMLIDY after
completion of hemodialysis treatment.
- Hepatic Impairment: Not recommended in patients with
decompensated (Child-Pugh B or C) hepatic impairment.
Indication
VEMLIDY is indicated for the treatment of chronic hepatitis B
virus (HBV) infection in adults with compensated liver disease.
About HDV
Chronic hepatitis delta virus (HDV) is the most severe form of
viral hepatitis and can have mortality rates as high as 50% within
5 years in cirrhotic patients. HDV occurs only as a co-infection in
individuals who have hepatitis B virus (HBV). It is estimated that
at least 12 million people worldwide are likely currently
co-infected with HDV and HBV. HDV co-infection is associated with a
faster progression to liver fibrosis, cirrhosis, hepatic
decompensation and an increased risk of liver cancer and death. In
the U.S. and Europe, there are approximately more than 230,000
people living with HDV, however it remains underdiagnosed
globally.
About Gilead Sciences in Liver
Disease
For more than 20 years, Gilead has sought to address some of the
biggest challenges in liver disease. The company has transformed
the trajectory of many liver diseases through a relentless pursuit
of innovation and pioneering access programs to bring meaningful
therapies to people around the world. More work is required, and
Gilead is committed to advancing innovative therapeutics to address
the most pressing unmet needs in liver disease and overcoming
barriers to better care.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer. Gilead operates 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 Gilead’s ability to initiate, progress or complete
clinical trials or studies within currently anticipated timelines
or at all, including those involving Hepcludex, Epclusa, Vemlidy,
cilofexor, firsocostat, inarigivir and selgantolimod; the
possibility of unfavorable results from ongoing or additional
clinical trials or studies, including those involving Hepcludex,
Epclusa, Vemlidy, cilofexor, firsocostat, inarigivir and
selgantolimod; the possibility that Gilead may make a strategic
decision to discontinue development of cilofexor, firsocostat,
inarigivir, selgantolimod and other investigational compounds and
as a result, the compounds may never be successfully
commercialized; Gilead’s ability to receive regulatory approvals in
a timely manner or at all, including FDA or EMA approval of
Hepcludex, and the risk that any such approvals may be subject to
significant limitations on use; and any assumptions underlying any
of the foregoing. These and other risks, uncertainties and factors
are described in detail in Gilead’s Quarterly Report on Form 10-Q
for the quarter ended March 31, 2021, as filed with the U.S.
Securities and Exchange Commission. These risks, uncertainties and
other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements. The reader is cautioned that
any such forward-looking statements are not guarantees of future
performance and is cautioned not to place undue reliance on these
forward-looking statements. All forward-looking statements are
based on information currently available to Gilead, and Gilead
assumes no obligation and disclaims any intent to update any such
forward-looking statements.
U.S. Prescribing Information for Epclusa and
Vemlidy including BOXED WARNINGS, are available at
www.gilead.com.
Hepcludex, Epclusa, Vemlidy, Gilead and the
Gilead logo are registered trademarks of Gilead Sciences, Inc., or
its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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Jacquie Ross, Investors (650) 358-1054
Rhiannon Bid, Media (Europe) +44 7824 530 487
Nat Sillin, Media (U.S.) (650) 866-9374
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