Daclatasvir+sofosbuvir regimen achieves
SVR12 in 90% of treatment-naïve and 86% of treatment-experienced
genotype 3 patients
ALLY-3 is the first Phase 3 study of an
all-oral, ribavirin-free treatment regimen for genotype 3 HCV
patients with a 12-week treatment duration
Genotype 3 is the second most common
genotype worldwide and has emerged as one of the most difficult to
treat
Bristol-Myers Squibb Company (NYSE:BMY) today announced
late-breaking data from the landmark ALLY Trial investigating a
ribavirin-free 12-week regimen of daclatasvir (DCV) in combination
with sofosbuvir (SOF) in genotype 3 hepatitis C (HCV) patients, a
patient population that has emerged as one of the most difficult to
treat. The results of the study, which showed sustained virologic
response 12 weeks after treatment (SVR12) in 90% of treatment-naïve
and 86% of treatment-experienced patients, 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.
“Both treatment naïve and treatment experienced patients in the
ALLY-3 study achieved high SVR rates. These results are encouraging
given that patients with genotype 3 have emerged as among the
hardest to treat,” said David R. Nelson, M.D., Professor of
Medicine, Molecular Genetics and Microbiology Director, UF Clinical
and Translational Science Institute, and Assistant Vice President
of Research for the University of Florida. “Genotype 3 is
associated with a more rapid progression of disease and remains a
challenge to the efficacy of even newer regimens. The ALLY-3
results demonstrate the possibility of bringing a cure to genotype
3 patients in an all-oral, 12-week regimen.”
These results build upon the existing body of data on the
daclatasvir and sofosbuvir combination. Data from an open-label,
randomized study of daclatasvir with sofosbuvir in
genotypes 1, 2, and 3 demonstrated that the 24-week regimen of
daclatasvir and sofosbuvir (± ribavirin) achieved SVR12 in 89% of
patients with genotype 3. The ALLY study presented at The Liver
Meeting investigates the regimen for 12 weeks, halving the previous
treatment duration. Other ongoing ALLY studies examine diverse HCV
populations across all genotypes: cirrhotic and post-liver
transplant patients, as well as treatment-naïve and
treatment-experienced patients who are co-infected with HIV.
“HCV is a complex disease, and the treatment community needs
multiple options to address the remaining unmet medical needs,”
said Douglas Manion, M.D., head of Specialty Development,
Bristol-Myers Squibb. “Daclatasvir has shown pan-genotypic activity
in bench research, a factor which is becoming increasingly
important as we learn more about the complexity of HCV. Further,
daclatasvir’s potential to be combined with many other agents,
including sofosbuvir, is significant in continuing to develop
additional treatment options that may help patients of all
genotypes achieve cure.”
In the ALLY-3 study, the daclatasvir and sofosbuvir combination
regimen was well tolerated, with no deaths, treatment-related
serious adverse events, or discontinuations due to adverse events.
The most frequent side effects (≥5%) were headache (19.7%), fatigue
(19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%),
abdominal pain and arthralgia (both 5.3%). Additionally, there were
17 (11.2%) treatment failures, with 16 relapses post-treatment and
1 rebound at the end of treatment. There were no viral
breakthroughs in this ribavirin-free regimen.
About ALLY-3: Study Design
This Phase 3 open-label clinical trial enrolled 152 genotype 3
HCV patients; 101 treatment-naïve patients and 51
treatment-experienced patients in 2 cohorts each received
daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks,
with 24 weeks of follow-up. The primary endpoint was SVR12 rates,
defined as HCV RNA < LLOQ target detected or not detected at
follow-up week 12 in treatment-naïve and treatment-experienced
patients.
The full abstract for the presentation is 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 Genotype 3
Genotype 3 is estimated to affect 54.3 million people and is the
second most common worldwide behind genotype 1 (83.4 million). It
is now potentially the most difficult-to-treat genotype, and the
more aggressive nature of genotype 3 lies in the damage it causes
to the liver, as it is associated with progressive disease,
increased rates of steatosis and a disproportionately increased
risk of hepatocellular carcinoma.
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.
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 will receive regulatory approval in the United
States, or if approved, that it will become a commercially
successful product. 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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