Daclatasvir-sofosbuvir 12-week regimen
resulted in:
96% hepatitis C cure rate among
patients with HVC genotype 1 disease (n=80/83)
100% hepatitis C cure rate among
patients with HCV genotype 2, 3 and 4 disease (n=26/26)
High HCV cure rates seen with no need to
alter existing HIV medication regimens
Bristol-Myers Squibb Company (NYSE:BMY) today announced results
from ALLY-2, a Phase III clinical trial evaluating the
investigational once-daily combination of daclatasvir and
sofosbuvir for the treatment of patients with chronic hepatitis C
virus (HCV) coinfected with HIV – a patient population that
historically has been challenging to treat in large part due to
potential drug-drug interactions between the therapy regimens used
to treat each infection.
“The results of ALLY-2 signal that nearly all HIV-HCV coinfected
patients in the study could be cured of hepatitis C with a 12-week
regimen on daclatasvir and sofosbuvir,” said David Wyles, M.D.,
ALLY-2 Lead Investigator and Associate Professor of Medicine in the
Department of Medicine, Division of Infectious Diseases at the
University of California San Diego. “The trial demonstrated the
dosing flexibility afforded by the daclatasvir-sofosbuvir regimen
did not require alteration of HIV medications because of potential
drug-drug interactions. This is a paramount consideration for
clinicians treating this patient population.”
Among ALLY-2 patients treated for 12 weeks (treatment-naïve and
-experienced), 97% (n=149/153) achieved cure (sustained virologic
response 12 weeks after treatment; SVR12). The study met the
primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1
patients achieving SVR12. Treatment with daclatasvir in combination
with sofosbuvir in this study showed high SVR rates, with no
discontinuations due to adverse events, and no serious adverse
events related to study medications throughout the treatment
phase.
“While substantial strides have been made in the battle against
hepatitis C, a significant number of patients with complicated
disease and treatment histories need additional treatment options
to help them achieve hepatitis C cure,” said Douglas Manion, M.D.,
head of Specialty Development, Bristol-Myers Squibb. “The ALLY-2
results show that daclatasvir paired with sofosbuvir produced high
cure rates in this trial regardless of the coinfected patients’ HCV
genotype.”
According to the Centers for Disease Control and Prevention
(CDC), about one quarter of HIV-infected persons in the United
States - approximately 300,000 people - are also infected with
hepatitis C, and HCV infection progresses more rapidly to liver
damage in people living with HIV.
In ALLY-2, high SVR rates occurred among all patients treated
for 12 weeks, regardless of prior treatment experience, HCV
genotype, cirrhosis status, concurrent combination antiretroviral
therapy regimen, or race. African-American patients comprised 34%
of study participants; in this patient demographic, SVR12 rates
were 98% (n=49/50). ALLY-2 also included an 8-week arm; 38 of 50
treatment-naïve patients with HCV achieved SVR12. However, study
investigators concluded that further studies are needed to assess
the potential of shorter-duration, all-oral treatment regimens.
Additional safety data demonstrated a low rate of Grade 3/4 lab
abnormalities in the study: INR (1%), AST (0.5%), Tbili (4%),
Lipase (3%).
About ALLY-2: Study Design
This Phase III open-label clinical trial randomized 151
treatment-naïve and 52 treatment-experienced HCV (genotypes 1-4)
patients coinfected with HIV-1 on a broad range of antiretroviral
regimens, into 3 cohorts. Among treatment-naïve patients, one
cohort received daclatasvir 30, 60, or 90 mg (dose adjusted for
concomitant antiretroviral therapy) plus sofosbuvir 400 mg once
daily for 12 weeks, and another received the same dosage and
combination for 8 weeks.
The treatment-experienced cohort also received daclatasvir 30,
60, or 90 mg plus sofosbuvir 400 mg once daily for 12 weeks.
Daclatasvir was dose-adjusted to accommodate concomitant
antiretrovirals: 30 mg with ritonavir-boosted PIs, 90 mg with
NNRTIs except rilpivirine. All cohorts had follow-up through
post-treatment week 24. The primary endpoint was the SVR12 rate
among genotype 1 treatment-naïve patients after 12 weeks of
treatment. Patients with cirrhosis were permitted.
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 NS5A
complex inhibitor which continues to be investigated in multiple
treatment regimens and in patients with co-morbidities.
Daclatasvir was approved in Europe in August 2014, and more
recently in Brazil in January 2015, 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.
Daclatasvir also is approved in Japan in combination
with asunaprevir, a NS3/4A protease inhibitor.
The daclatasvir+asunaprevir 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.
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,
2014, 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:Robert Perry,
Office: 609-419-5378Cell:
407-492-4616rob.perry@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.com
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