Daclatasvir TRIO achieves 98% cure rate in
treatment-naïve and 93% cure rate in treatment-experienced genotype
1 patients with cirrhosis when used with ribavirin, as shown in
UNITY 2
12-week, all-oral treatment halves current
regimen duration for hard-to-manage treatment-experienced genotype
1 patients with cirrhosis
Fixed-dose regimen also demonstrates 91% SVR
rates in non-cirrhotic genotype 1 patients without requiring use of
ribavirin
Bristol-Myers Squibb Company (NYSE:BMY) today announced
late-breaking data from the UNITY Trial program investigating a
12-week regimen of its all-oral daclatasvir (DCV) TRIO regimen – a
fixed-dose combination of daclatasvir with asunaprevir (ASV) and
beclabuvir (BCV) – in a broad range of patients with genotype 1
hepatitis C virus (HCV). The data will be presented at The Liver
Meeting® 2014, the Annual Meeting of The American Association for
the Study of Liver Diseases (AASLD), in Boston, MA, November 7 –
11. The primary endpoint for both studies was the percentage of
patients who achieved cure, defined as HCV RNA<LLOQ TD/TND at
post-treatment week 12 for treatment-naïve and
treatment-experienced patients.
The UNITY-2 study, which evaluated cirrhotic patients in a
12-week regimen of the DCV-TRIO, showed sustained virologic
response 12 weeks after treatment (SVR12) among 98% of
treatment-naïve and 93% of treatment-experienced cirrhotic patients
with ribavirin (RBV) and 93% of treatment-naïve and 87% of
treatment-experienced cirrhotic patients without ribavirin.
“Even with the most recent HCV treatment advances, genotype 1
patients with cirrhosis remain difficult to treat,” said Andrew J.
Muir, M.D., MHS, Associate Professor of Medicine; Clinical
Director, Gastroenterology & Transplant Hepatology, Duke
Gastroenterology. “Currently, treatment-experienced cirrhotic
patients still require a 24-week regimen to achieve high SVR rates.
The data from this clinical trial using the DCV-TRIO regimen showed
high cure rates for this population in a 12-week regimen, and has
the potential to aid treatment adherence and provide a shorter
treatment duration to achieve cure.”
Study Design and Results
The Phase 3 UNITY clinical trial program is an ongoing study
investigating 12-week regimens of the DCV-TRIO fixed-dose
combination (daclatasvir 30 mg plus asunaprevir 200 mg plus
beclabuvir 75 mg) in non-cirrhotic and cirrhotic genotype 1
patients.
The open-label UNITY-1 study evaluated a 12-week regimen of the
DCV-TRIO without ribavirin in treatment-naïve and -experienced
non-cirrhotic patients. Non-cirrhotic treatment-naïve patients
(n=312) and treatment-experienced patients (n=103) received the
DCV-TRIO fixed-dose combination in one pill twice daily for 12
weeks, with 24 weeks of follow-up. The majority of the patients
(73%) were genotype 1a, and 91% of all patients achieved SVR12. 92%
of treatment-naive patients and 89% of treatment-experienced
patients achieved cure, without the use of ribavirin.
In the UNITY-2 study, both cirrhotic treatment-naïve and
treatment-experienced patients received the DCV-TRIO fixed-dose
combination, one arm without ribavirin (n=102) and one with
ribavirin (n=100). The study was double-blinded to ribavirin, and
the majority of the patients (74%) were genotype 1a. The study
showed 96% of all patients who received the DCV-TRIO with ribavirin
achieved SVR12, and 90% of those who received the DCV-TRIO without
ribavirin achieved SVR12.
“The Phase 3 UNITY results for the daclatasvir TRIO fixed-dose
combination are particularly compelling for genotype 1 patients
with cirrhosis, whose treatment is often harder to manage than
non-cirrhotic patients,” said Douglas Manion, M.D., head of
Specialty Development, Bristol-Myers Squibb. “BMS continues to
recognize that HCV is an extremely complicated disease with no
‘one-size-fits-all’ treatment solution, and the UNITY results are
especially promising for serving patients with cirrhosis, a
specific but significant portion of genotype 1 patients.”
In both UNITY-1 and UNITY-2 there were low rates of adverse
events (AEs) leading to discontinuation and of serious adverse
events (SAEs) overall. In UNITY-1 there were 7 SAEs, all considered
not related to study treatment, and 3 AEs leading to treatment
discontinuation. The most common AEs were headache (25.8%) and
fatigue (16.6%). In UNITY-2, there were 3 SAEs related to treatment
and 4 AEs leading to discontinuation. The most common AEs were
headache and fatigue (both 19.8%).
Full abstracts for both presentations are available at The Liver
Meeting website.
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted
through direct contact with infected blood and blood products.
Approximately 170 million people worldwide are infected with
hepatitis C, with an estimated 2.7–3.9 million chronically infected
in the United States. Up to 90 percent of those infected with
hepatitis C will not spontaneously clear the virus and will become
chronically infected. According to the World Health Organization,
up to 20 percent of people with chronic hepatitis C will develop
cirrhosis; of those, up to 20 percent may progress to liver
cancer.
About Bristol-Myers Squibb’s HCV Portfolio
Bristol-Myers Squibb’s research efforts are focused on advancing
late-stage compounds to deliver the most value to patients with
hepatitis C. At the core of our pipeline is daclatasvir, a potent
pan-genotypic NS5A complex inhibitor (in vitro), which continues to
be investigated in multiple treatment regimens and in people with
co-morbidities.
Daklinza (daclatasvir) was recently approved in the EU for
use in combination with other medicinal products across genotypes
1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV)
infection in adults. Daklinza is also approved in Japan in
combination with Sunvepra (asunaprevir), a NS3/4A protease
inhibitor. The Daklinza+Sunvepra Dual Regimen is Japan’s
first all-oral, interferon- and ribavirin-free treatment regimen
for patients with genotype 1 chronic HCV infection, including those
with compensated cirrhosis.
In 2013, Bristol-Myers Squibb’s investigational all-oral
DCV-TRIO regimen (daclatasvir/asunaprevir/beclabuvir) received
Breakthrough Therapy Designation in the U.S., which helped to
expedite the start of the ongoing Phase 3 UNITY program. Study
populations include non-cirrhotic naïve, cirrhotic naïve and
previously treated patients. In addition to UNITY 1 and 2, both the
UNITY-3 study among Japanese treatment-naïve and -experienced
genotype 1 patients and UNITY-4, which studies the DCV-TRIO regimen
without ribavirin in cirrhotic and non-cirrhotic patients in Korea,
Russia and Taiwan, are currently ongoing. The DCV-TRIO regimen is
being studied as a fixed-dose-combination treatment with twice
daily dosing.
Additional studies with daclatasvir in combination with
sofosbuvir are being conducted in high unmet need patients, such as
pre- and post-transplant patients, HIV/HCV co-infected patients and
patients with genotype 3 as part of the ongoing Phase 3 ALLY
Program.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit http://www.bms.com or follow us
on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that daclatasvir or asunaprevir or any other compounds mentioned in
this release will receive regulatory approval in the United States,
or if approved, that they will become commercially successful
products. Forward-looking statements in this press release should
be evaluated together with the many uncertainties that affect
Bristol-Myers Squibb's business, particularly those identified in
the cautionary factors discussion in Bristol-Myers Squibb's Annual
Report on Form 10-K for the year ended December 31, 2013, in our
Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events or otherwise.
Bristol-Myers Squibb CompanyMedia:Carrie Fernandez,
Office: 609-419-5448Cell:
215-859-2605carrie.fernandez@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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