Bristol-Myers Squibb to Present New Data Demonstrating Company's Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting
Late breaker oral presentation will feature first report of SVR4results from an interferon- and ribavirin-free, 12-week, triple DAA, investigational regimen of daclatasvir, asunaprevir and BMS-791325 in hepatitis C (HCV)
Oral presentations on HCV investigational compounds daclatasvir, asunaprevir and peginterferon lambda-1a (Lambda) demonstrate diversity of portfolio
Late breaker poster presentations will report Phase II data on Lambda in the treatment of HCV and chronic hepatitis B
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYS: BMY) announced today that 27 abstracts on the Company's research in liver disease have been accepted for presentation at The Liver Meeting® 2012, the 63rd annual meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, November 9 - 13.
Bristol-Myers Squibb is studying a portfolio of compounds with the potential to address unmet medical needs for patients with liver disease, including the investigational compounds daclatasvir, asunaprevir, Lambda and BMS-791325 being studied in hepatitis C (HCV), Lambda being studied in hepatitis B (HBV), and BARACLUDE® (entecavir). BARACLUDE is currently indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in aminotransferases (ALT or AST), or histologically active disease.
Key presentations include:
A late breaker oral presentation of SVR4 results with an interferon- and ribavirin (RBV)-free, 12-week regimen of daclatasvir, asunaprevir and BMS-791325 in a Phase II study of treatment-naïve patients with chronic HCV genotypes 1, 2 or 3
An oral presentation of SVR12 results with a regimen of daclatasvir and asunaprevir, with or without alfa interferon (alfa)/RBV, in a Phase II study of chronic HCV genotype 1 null responders
A late breaker oral presentation on the first report of SVR4 results from 12-week treatment arms of a Phase II study of daclatasvir and GS-7977, with or without RBV, in treatment-naïve patients with chronic HCV genotype 1, 2 or 3
A late breaker poster presentation on SVR12 results from the D-LITE Phase II study of Lambda in combination with RBV and either daclatasvir or asunaprevir in patients with chronic HCV genotype 1
A late breaker poster presentation on Lambda versus alfa in a Phase II study of patients with chronic hepatitis B
"Bristol-Myers Squibb has a long-term commitment to viral hepatitis and has been at the forefront of the evolving science in both hepatitis B and C, where there remains considerable unmet medical need," said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. "In hepatitis C, we believe improving treatment outcomes requires a personalized approach to meet the needs of the diverse patient population. The data we are presenting at AASLD help expand our understanding of the potential efficacy and safety profiles of our investigational hepatitis C compounds and support our ongoing Phase III development programs."
The Company will also show three presentations of outcomes research/real-world data that add to the understanding of the prevalence of and current treatment patterns in HBV, HCV and hepatocellular carcinoma (HCC).
The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the AASLD website at http://aasld2012.abstractcentral.com/.
Chronic Hepatitis B: BARACLUDE (entecavir) Clinical Data
Entecavir + Adefovir Versus Lamivudine + Adefovir Or Entecavir Alone In
Antiviral Efficacy of Entecavir in Black/African American and Hispanic
Randomized, observational study of long-term entecavir treatment versus
Disease and Treatment Perceptions Among Asian Americans Diagnosed
Hepatitis C: Direct-Acting Antiviral Data
Sustained Virologic Response in Chronic HCV Genotype (GT) 1-Infected
First Ever Successful Use of Daclatasvir and GS-7977, an Interferon-Free
Comparison of Pre-Existing and Emerging Resistance-Associated Variants
Characterization of HCV NS5A Resistance Variants in Naive Patients
Characterization of HCV Genotype 1 NS5A Resistance Variants From the
Twelve- or 16-Week Treatment With Daclatasvir Combined With
Daclatasvir, an NS5A Replication Complex Inhibitor, Combined With
High Rate of Sustained Virologic Response with the All-Oral Combination
An Interferon-free, Ribavirin-free 12-Week Regimen of Daclatasvir (DCV),
Asunaprevir in Japanese Subjects in Phase 2: Exposure-Safety Versus
Effect of Hepatic Impairment on the Pharmacokinetics of
Hepatitis C and B: PEG-Interferon Lambda Data
Peginterferon Lambda-1a (Lambda) is less likely to induce clinically
Peginterferon Lambda-1a (Lambda) is Associated With Less Autoimmune
Peginterferon Lambda, a New Potential Therapeutic Option for the
Sustained Virologic Response (SVR12) in HCV Genotype 1 Patients
Peginterferon Lambda-1a (Lambda) Compared to Peginterferon Alfa-2a
First Report of Peginterferon Lambda/Ribavirin in Combination With Either
Baseline CXCR3 Ligand Levels are Associated With Early Virologic
Pegylated Interferons Lambda-1a and Alfa-2a Display Different Gene
Hepatitis C: Outcomes Research / Real-World Data
Genome-Wide Association Study to Identify Potential Single Nucleotide
Reasons for Treatment (Tx) Discontinuation Among Hepatitis C (HCV)
Hepatocellular Carcinoma: Brivanib Data
Brivanib (BRI) versus Sorafenib (SOR) as First-line Therapy in Patients
Hepatocellular Carcinoma: Outcomes Research
Observations of Hepatocellular Carcinoma (HCC) Management Patterns
INDICATION and IMPORTANT SAFETY INFORMATION aboutBARACLUDE (entecavir) Tablets:
BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating BARACLUDE (entecavir):
This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease.
Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.
Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy.
IMPORTANT SAFETY INFORMATION
WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals.
Warnings and Precautions
Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.
Lactic acidosis with BARACLUDE (entecavir) use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
In clinical trials in patients with compensated liver disease, the most common (≥3%) adverse reactions of any severity with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia.
In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE, regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE (entecavir) patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes.
BARACLUDE is primarily eliminated by the kidneys, therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs.
Pregnancy and Nursing Mothers
There are no adequate and well-controlled studies of BARACLUDE in pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits.
There are no studies on the effect of BARACLUDE (entecavir) on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast-feeding or discontinue BARACLUDE in nursing women.
Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established.
Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis.
The safety and efficacy of BARACLUDE in liver transplant recipients are unknown. Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.
Dosage and Administration
BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).
The recommended dose of BARACLUDE:
in nucleoside-naïve adults and adolescents (16+ yrs) with compensated liver disease is 0.5 mg once daily
in adults and adolescents (16+ yrs) with compensated liver disease, and refractory to lamivudine or with known lamivudine or telbivudine resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L) is 1 mg once daily
in adults with decompensated liver disease is 1 mg once daily
The optimal duration of treatment with BARACLUDE (entecavir) for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.
BARACLUDE is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
Please see accompanying Full Prescribing Information, including Boxed WARNINGS, or click here.
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.
BARACLUDE®(entecavir) is a registered trademark of Bristol-Myers Squibb.
KEYWORDS: United States North America Massachusetts New Jersey
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