- Phase 2b Data Presented at EASL and
Published in NEJM Show Potential for Bulevirtide 10 mg in
Combination with Pegylated Interferon Alfa-2a as Finite Therapy for
People with Chronic Hepatitis Delta -
- Data Published in NEJM Demonstrate 46% of
Patients Taking Bulevirtide 10 mg with PegIFN Achieved
Post-Treatment Undetectable HDV RNA at Week 24 -
- Data Presented at EASL Demonstrate
Consistent Study Findings of Undetectable HDV RNA at Week 48
-
Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from
the Phase 2b MYR204 open-label study assessing the efficacy and
safety of the first-in-class entry inhibitor bulevirtide as
monotherapy and in combination with pegylated interferon alfa-2a
(PegIFN), in adults living with compensated chronic hepatitis delta
virus (HDV) infection. Published in the New England Journal of
Medicine (NEJM), the data demonstrate that the investigational
combination of bulevirtide 10 mg with PegIFN was superior to
investigational bulevirtide 10 mg monotherapy in achieving
undetectable HDV RNA (lower limit of quantification (LLOQ), target
not detected) at Week 24 after the end of treatment (EOT). The end
of study data presented at the European Association for the Study
of the Liver (EASL) Congress 2024, demonstrate that treatment with
bulevirtide 10 mg in combination with PegIFN maintained a 46% rate
of undetectable HDV RNA at Week 48 after EOT, confirming its
potential as a finite therapy for adults living with chronic HDV.
HDV affects an estimated 5% of people living with chronic hepatitis
B (HBV), with a global prevalence of more than 12 million
people.
“HDV is the most severe form of viral hepatitis. For people
living with HDV, bulevirtide 2 mg has been proven to be a
successful long-term treatment approach, as highlighted in clinical
trials and real-world data. These new data support the potential
for bulevirtide as a finite treatment option, demonstrating that
almost half of people treated with bulevirtide 10 mg in combination
with PegIFN remained undetectable for HDV RNA one year after
treatment cessation,” said Tarik Asselah, MD, PhD, Professor of
Hepatology, Hôpital Beaujon APHP, Université Paris-Cité, Head of
Viral Hepatitis, UMR1149 Inserm and principal investigator of the
study. “These long-term data are the highest post-treatment
response rates ever reported for HDV.”
Bulevirtide 2 mg remains the only approved treatment for adults
with chronic HDV and compensated liver disease in the European
Economic Area (EEA), Great Britain and Switzerland and is not
approved in the U.S. Bulevirtide 10 mg is an investigational
product and is not approved anywhere.
Data published in NEJM demonstrate that at Week 24 after EOT,
undetectable HDV RNA was achieved by 32% and 46% of patients taking
bulevirtide 2 mg in combination with PegIFN and bulevirtide 10 mg
in combination with PegIFN, respectively. In the monotherapy
groups, PegIFN monotherapy and bulevirtide 10 mg monotherapy,
undetectable HDV RNA was achieved by 17% and 12%, respectively. The
safety profiles of bulevirtide in combination with PegIFN were
consistent with those of the individual components. The most
frequent adverse events were leukopenia, neutropenia and
thrombocytopenia, and most were mild to moderate.
Data presented at EASL (GS-002) demonstrate that at Week 48
after EOT, undetectable HDV RNA was achieved by 26% and 46% of
patients taking bulevirtide 2 mg in combination with PegIFN and
bulevirtide 10 mg in combination with PegIFN, respectively. In the
monotherapy groups, PegIFN monotherapy and bulevirtide 10 mg
monotherapy, undetectable HDV RNA was achieved by 25% and 12%,
respectively.
“Chronic HDV can greatly impact those affected due to its rapid
progression to liver failure, liver cancer and liver-related death.
With these promising finite data for bulevirtide, we have the
opportunity to support healthier futures for people living with
HDV,” said Anu Osinusi, VP, Clinical Research for Hepatitis,
Respiratory and Emerging Viruses, Gilead Sciences. “In addition to
highlighting the curative potential of combination therapy for some
people with chronic HDV, these final data support the safety
profile of bulevirtide. Ultimately, our focus remains on bringing
treatment options to more people living with chronic HDV.”
Also at EASL, late-breaking data (LB-309) on the pivotal Phase 3
MYR301 study evaluating bulevirtide as monotherapy for the
treatment of adults with chronic HDV infection were also presented
and reinforced bulevirtide as an efficacious and generally
well-tolerated long-term treatment option. Patients had similar
rates of combined response (virologic response and ALT
normalization) at Week 144 compared to Week 96, with 57% and 54%,
respectively, among those receiving bulevirtide 2 mg or 10 mg. This
is consistent with and builds on the data shared at EASL 2023.
Bulevirtide continued to be generally well-tolerated through Week
144, and the safety profile was similar between the bulevirtide 2
mg and 10 mg treatment arms, with the study investigators
attributing no serious adverse events to bulevirtide treatment.
Through 144 weeks of treatment, dose-dependent increases in bile
acids remained asymptomatic, were not associated with any clinical
sequelae and did not result in any discontinuations or treatment
interruption.
In July 2023, the European Commission (EC) granted full
Marketing Authorization (MA) for Hepcludex® (bulevirtide) 2 mg for
the treatment of adults with chronic HDV and compensated liver
disease. Bulevirtide was initially granted conditional MA from the
EC in July 2020 to provide people living with HDV urgent access to
treatment. Bulevirtide’s conditional MA license in Great Britain
was converted to a full MA in August 2023, and a full MA was
granted in Switzerland in February 2024. In regions where it is not
approved, including the U.S., bulevirtide 2 mg is an
investigational product. In these regions, health authorities have
not established the safety and efficacy of bulevirtide.
About MYR204
The MYR204 study was a randomized, open-label, controlled,
parallel-group, multicenter, Phase 2b trial, in which a total of
174 patients were randomized and received PegIFN alone for 48
weeks; bulevirtide 2 mg with PegIFN for 48 weeks, followed by
bulevirtide 2 mg alone for 48 weeks; bulevirtide 10 mg with PegIFN
for 48 weeks, followed by bulevirtide 10 mg alone for 48 weeks; or
bulevirtide 10 mg alone for 96 weeks. All patients were followed
for an additional 48 weeks after EOT. The primary endpoint of
MYR204 was undetectable HDV RNA at 24 weeks after EOT. Secondary
efficacy endpoints included undetectable HDV RNA at Week 48 (all
groups) during treatment, undetectable HDV RNA at Week 96 (all
bulevirtide groups) during treatment, and undetectable HDV RNA at
Week 48 after EOT (all groups).
About MYR301
MYR301 is an ongoing, Phase 3 clinical trial evaluating the
long-term efficacy and safety of bulevirtide in 150 people living
with chronic HDV randomly allocated to treatment with bulevirtide 2
mg once daily (n=49), 10 mg once daily (n=50) or no antiviral
treatment (delayed treatment, n=51). Primary efficacy and safety
data were assessed at Week 48. After Week 48, patients in the
delayed treatment group of the study were switched to bulevirtide
10 mg once daily for an additional 96 weeks. The total duration of
treatment across all groups in the study is 144 weeks. The primary
endpoint, combined response, is defined as an undetectable HDV RNA
or ≥ 2log10 IU/ml decline from baseline and ALT normalization at
Week 48. Secondary endpoints at Week 48 include undetectable HDV
RNA (key secondary endpoint), ALT normalization, and a change from
baseline in liver stiffness measured by transient elastography.
About HDV
HDV is considered the most aggressive or severe form of viral
hepatitis, associated with more rapid progression towards
liver-related death and liver cancer in people with HBV. On
average, HDV progresses to cirrhosis within five years and to liver
cancer within 10 years. Nearly 5% of people who have a chronic
infection with HBV are estimated to have HDV, equating to 12-15
million people worldwide. The prevalence of HDV infection is
largely underestimated due to lack of universal testing of HBV
positive individuals for HDV.
About Gilead Sciences in Liver
Disease
For decades, Gilead has pioneered the way forward to improve the
lives of people living with liver disease around the world. We have
helped to transform hepatitis C from a chronic condition into one
that can be cured for millions of people. For people living with
hepatitis B or D, our focus on advancing our medicines drives hope
that today’s research will turn into tomorrow’s cures. Beyond viral
hepatitis, we’re working to deliver advanced treatments for people
living with primary biliary cirrhosis (PBC). But our commitment
doesn’t stop there. Through our ground-breaking science and
collaborative partnerships, we strive to create healthier futures
for everyone living with liver disease. We are committed to a
future without liver disease.
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, COVID-19, cancer and inflammation. Gilead operates
in more than 35 countries worldwide, with headquarters in Foster
City, California.
Forward-Looking
Statements
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, and the possibility of unfavorable results from ongoing
or additional clinical trials or studies, including those involving
Hepcludex (bulevirtide); uncertainties relating to regulatory
applications and related filing and approval timelines, including
the risk that the FDA and other regulatory authorities may not
approve bulevirtide for the treatment of HDV, and the risk that any
such approvals, if granted, 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, 2024, 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 involve risks and uncertainties 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.
Hepcludex, 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 X
(@Gilead Sciences), or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20240606954431/en/
Meaghan Smith, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
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