Real-world use of Daklinza-based regimens
complements clinical findings across various HCV patient populations
Results of ALLY-3+ trial in genotype 3 HCV patients with cirrhosis
to provide new insights into treating this patient population
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE:BMY) announced today that 17 abstracts have
been accepted for presentation at The Liver Meeting® 2015,
the annual meeting of The American Association for the Study of Liver
Diseases (AASLD) 2015, taking place in San Francisco, CA., from November
13 – 17.
Highlights include:
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Real-world data in chronic hepatitis C (HCV) populations, including
genotype 3 patients, post-liver transplant patients, patients with
advanced liver disease (including decompensated cirrhosis) and those
coinfected with HIV.
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Late-breaking data from the ALLY-3+ clinical trial, a study of
Daklinza (daclatasvir) and sofosbuvir with ribavirin in genotype 3
HCV patients with cirrhosis.
“The data to be presented at this year’s AASLD conference reinforces
Bristol-Myers Squibb’s ongoing commitment to investigating Daklinza-based
treatments that could address the still-challenging needs of many
patients living with chronic viral hepatitis C,” said Douglas Manion,
M.D., head of Specialty Development, Bristol-Myers Squibb. “We are
aiming to ultimately help a diverse range of hepatitis C patient
populations.”
The complete list of Bristol-Myers Squibb data presentations follows.
More information is available at http://www.aasld.org/.
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Title
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Date/Time
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Oral Presentation:
All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF)
Plus Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT)
3-Infected Patients With Advanced Fibrosis or Cirrhosis: The
ALLY-3+ Phase 3 Study
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Session: Late-breaking Abstract Session
Date: November 16, 2015
Session Time: 3:00 – 4:30 p.m.
Publication Number: LB-3
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Oral Presentation:
Safety and efficacy of daclatasvir plus sofosbuvir with or without
ribavirin for the treatment of chronic HCV genotype 3 infection:
Interim results of a multicenter European compassionate use program
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Session: Parallel 5: Hepatitis C: Pre-Approval
Clinical Studies I
Date: November 15, 2015
Session Time: 3:00 - 4:30 p.m.
Presentation Time: 3:00 - 3:15 p.m.
Location: General Session/3000 (Moscone Center)
Publication Number: 37
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Oral Presentation:
Daclatasvir plus sofosbuvir with or without ribavirin in genotype
3 patients from a large French multicenter compassionate use
program
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Session: Viral Hepatitis Plenary
Date: November 17, 2015
Session Time: 8:00 - 9:30 a.m.
Presentation Time: 8:15 - 8:30 a.m.
Location: Room 3000 (Moscone Center)
Publication Number: 206
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Oral Presentation:
Daclatasvir and Sofosbuvir in Patients with Recurrent HCV
Following Liver Transplantation and Advanced Fibrosis or
Cirrhosis: United States Multicenter Treatment Protocol
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Session: Parallel 32: Clinical Aspects of HCV Virology,
Pathogenesis, and Immunology
Date: November 17, 2015
Session Time: 11:15 a.m. -12:45 p.m.
Presentation Time: 12:00 -12:15 p.m.*
Location: Room 3014 (Moscone Center)
Publication Number: 217
* Presentation time expected to change, TBC
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Oral Presentation:
Daclatasvir in combination with sofosbuvir with or without
ribavirin is safe and efficacious in liver transplant recipients
with HCV recurrence: Interim results of a multicenter
compassionate use program
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Session: Parallel 37: Hepatitis C: Pre-Approval Clinical
Studies II
Date: November 17, 2015
Session Time: 11:15 a.m. - 12:45 p.m.
Presentation Time: 12:30 - 12:45 p.m.
Location: General Session/3000 (Moscone Center)
Publication Number: 252
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Presidential Poster of Distinction:
702 Short-duration therapy with daclatasvir/asunaprevir/beclabuvir
fixed-dose combination plus sofosbuvir in patients with chronic
hepatitis C genotype 1 (FOURward Study)
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:00 – 7:30 p.m.
Location: Poster Hall
Publication Number: 702
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Presidential Poster of Distinction:
Daclatasvir plus sofosbuvir with or without ribavirin for the
treatment of chronic HCV in patients coinfected with HIV: Interim
results of a multicenter compassionate use program
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Session: Hepatitis C: Therapeutics /Approved Agents
Date: November 15, 2015
Presentation Time: 8:00 a.m. – 5:30 p.m.
Location: Poster Hall
Publication Number: 1058
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Poster: Improvement in
liver disease parameters following treatment with daclatasvir +
sofosbuvir and ribavirin in patients with chronic HCV infection
and advanced cirrhosis
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:00 – 7:30 p.m.
Location: Poster Hall
Publication Number: 706
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Poster: Baseline HCV
NS5A resistance-associated variants do not impact SVR12 rates in
non-cirrhotic and post-liver transplant patients with genotype 1
infection treated with daclatasvir and sofosbuvir with or without
ribavirin for 12 weeks: An integrated analysis
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:00 – 7:30 p.m.
Location: Poster Hall
Publication Number: 709
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Poster: Comparative
Efficacy and Tolerability of Daclatasvir + Sofosbuvir versus
Sofosbuvir + Ribavirin in Patients with Chronic Hepatitis C
Coinfected with HIV: A Matching-Adjusted Indirect Comparison
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:00 – 7:30 p.m.
Location: Poster Hall
Publication Number: 711
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Poster: An integrated
safety analysis of daclatasvir + sofosbuvir, with or without
ribavirin, in patients with chronic HCV infection
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:00 – 7:30 p.m.
Location: Poster Hall
Publication Number: 716
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Poster: Daclatasvir
exposure does not explain lower sustained virologic response rates
in cirrhotic patients with HCV genotype 3 following 12 weeks of
daclatasvir plus sofosbuvir treatment
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:30 – 7:00 p.m.
Location: Poster Hall
Publication Number: 720
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Poster: Integrated
Safety Analysis of Daclatasvir Plus Sofosbuvir, With or Without
Ribavirin, in Patients With HCV Genotype 3 Infection
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:00 – 7:30 p.m.
Location: Poster Hall
Publication Number: 726
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Poster: Daclatasvir
exposure alone does not explain HCV relapse in HIV-HCV coinfected
patients receiving daclatasvir plus sofosbuvir with
ritonavir-boosted darunavir in the ALLY-2 study
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Session: Therapeutics: New Agents (not approved, Phase 2-3)
Date: November 14, 2015
Presentation Time: 2:00 – 7:30 p.m.
Location: Poster Hall
Publication Number: 728
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Poster: Daclatasvir and
asunaprevir in non-Japanese Asian patients with chronic HCV
genotype 1b infection who are ineligible for or intolerant to
interferon-alfa therapies with or without ribavirin: Phase 3 SVR12
interim results
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Session: Late-breaking Poster Session
Date: November 16, 2015
Session Time: 8:00 a.m. – 5:30 p.m.
Presenters available: 12:30 – 2:00 p.m.
Location: Poster Hall
Publication Number: LB-18
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Poster: Impact of
Daclatasvir-Sofosbuvir Combination Treatment on Medical Events and
Costs in Patients Infected with Genotype 3 Hepatitis C Virus
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Session: Cost-Effectiveness and Economics of Care
Date: November 16, 2015
Presentation Time: 8:00 a.m. – 5:30 p.m.
Location: Poster Hall
Publication Number: 1456
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Poster:
Cost-effectiveness of Daclatasvir in Combination with Sofosbuvir
for the Treatment of Subjects with Genotype 3 Chronic Hepatitis C
Infection in the United States
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Session: Cost-Effectiveness and Economics of Care
Date: November 16, 2015
Presentation Time: 8:00 a.m. – 5:30 p.m.
Location: Poster Hall
Publication Number: 1461
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About Bristol-Myers Squibb in HCV
Bristol-Myers Squibb’s research efforts are focused on advancing
compounds to deliver the most value to HCV patients with high unmet
needs. At the core of our portfolio is Daklinza, a NS5A complex
inhibitor which continues to be investigated in multiple treatment
regimens and in patients with high disease burden.
In July 2014, Japan became the first country in the world to approve the
use of a Daklinza-based regimen for the treatment of chronic HCV.
Since then, Daklinza-based regimens have been approved in more
than 50 countries, including the United States, across Europe, and in
numerous other countries in Central and South America, the Middle East
and the Asia-Pacific region.
Indication and Important Safety Information - Daklinza™ (daclatasvir)
INDICATION
Daklinza™ (daclatasvir) is indicated for use with sofosbuvir for the
treatment of patients with chronic hepatitis C virus (HCV) genotype 3
infection.
Limitations of Use:
-
Sustained virologic response (SVR) rates are reduced in HCV genotype
3-infected patients with cirrhosis receiving Daklinza in combination
with sofosbuvir for 12 weeks.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
-
Drugs Contraindicated with Daklinza: strong inducers of CYP3A
that may lead to loss of efficacy of Daklinza include, but are not
limited to:
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Phenytoin, carbamazepine, rifampin, St. John’s wort (Hypericum
perforatum).
WARNINGS and PRECAUTIONS
-- Risk of Adverse Reactions or Loss of Virologic Response Due
to Drug Interactions: Coadministration of Daklinza and other drugs may
result in known or potentially significant drug interactions.
Interactions may include the loss of therapeutic effect of Daklinza and
possible development of resistance, dosage adjustments for other agents
or Daklinza, possible clinically significant adverse events from greater
exposure for the other agents or Daklinza.
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Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir
and Amiodarone: Post-marketing cases of symptomatic bradycardia
and cases requiring pacemaker intervention have been reported when
amiodarone is coadministered with sofosbuvir in combination with
another direct-acting antiviral, including Daklinza. A fatal cardiac
arrest was reported with ledipasvir/sofosbuvir.
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Coadministration of amiodarone with Daklinza in combination with
sofosbuvir is not recommended. For patients taking amiodarone who
have no alternative treatment options, patients should undergo
cardiac monitoring, as outlined in Section 5.2 of the prescribing
information.
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Bradycardia generally resolved after discontinuation of HCV
treatment.
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Patients also taking beta blockers or those with underlying
cardiac comorbidities and/or advanced liver disease may be at
increased risk for symptomatic bradycardia with coadministration
of amiodarone.
ADVERSE REACTIONS
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The most common adverse reactions were (= 5%): headache (14%),
fatigue (14%), nausea (8%), and diarrhea (5%).
DRUG INTERACTIONS
-
CYP3A: Daklinza is a substrate. Moderate or strong inducers may
decrease plasma levels and effect of Daklinza. Strong inhibitors
(e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) may
increase plasma levels of Daklinza.
-
P-gp, OATP 1B1 and 1B3, and BCRP: Daklinza is an inhibitor, and
may increase exposure to substrates, potentially increasing or
prolonging their adverse effect.
See Section 7 of the Full Prescribing Information for additional
established and other potentially significant drug interactions and
related dose modification recommendations.
Daklinza in Pregnancy: No data with Daklinza in pregnant women
are available to inform a drug-associated risk. Animal studies of
Daklinza at exposure above the recommended human dose have shown
maternal and embryofetal toxicity. Consider the benefits and risks of
Daklinza when prescribing Daklinza to a pregnant woman.
Nursing Mothers: Daklinza was excreted into the milk of lactating
rats; it is not known if Daklinza is excreted into human milk. Consider
the benefits and risks to the mother and infant when breastfeeding.
Please click here
for the Daklinza full prescribing information
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 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.
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.
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Source: Bristol-Myers Squibb Company