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Tuesday, April 9, 2013

Bristol-Myers Squibb to Present New Data on Hepatitis C and Hepatitis B Compounds at The International Liver CongressTM (ILC) 2013

  • New data on an investigational, all-oral, triple DAA regimen of daclatasvir, asunaprevir and BMS-791325 to be included in official ILC Press Conference on April 24
  • New ALT flare data further characterize profile of peginterferon lambda-1a (Lambda) as investigational treatment for Chronic Hepatitis B (CHB)
  • Breadth of data underscores Company’s commitment to advancing the treatment of liver disease

 
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 14 abstracts on the Company’s research in liver disease have been accepted for presentation at The International Liver CongressTM 2013, the 48th annual meeting of the European Association for the Study of the Liver (EASL), in Amsterdam, April 24 – 28.
Key presentations include:
  • New Phase 2 data on an investigational triple direct-acting antiviral (DAA) regimen of daclatasvir (NS5A replication complex inhibitor), asunaprevir (NS3 protease inhibitor) and BMS-791325 (NS5B non-nucleotide polymerase inhibitor) in patients with hepatitis C (HCV) genotypes 1a and 1b. The regimen is being studied as a potential interferon alfa-, ribavirin- and ritonavir-free treatment option to avoid the tolerability and drug-drug interaction profiles of these medicines. These triple DAA data will be highlighted in the official ILC Press Conference on April 24.
  • An analysis of all available safety data on 1,100 patients who received daclatasvir plus interferon alfa and ribavirin in Phase 2 studies. These data support the ongoing Phase 3 development program for daclatasvir and further studies of daclatasvir as a component of DAA-based HCV treatment regimens.
  • A characterization of ALT flares observed in hepatitis B (HBV) treatment with the investigational interferon Lambda vs. alfa interferon, reflecting differing profiles for the two compounds. Lambda is being developed as a potential alternative for alfa wherever interferon is used in the treatment of either HCV or HBV.
  • An analysis of sustained virologic response with daclatasvir plus sofosbuvir, with or without ribavirin, in patients with HCV genotype 1 who previously failed telaprevir or boceprevir.
“Bristol-Myers Squibb has a longstanding commitment to viral hepatitis and has been at the forefront of the evolving science in both hepatitis B and C,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The data we are presenting at the International Liver Congress demonstrate our continued advancement of research to address unmet medical needs, through the development of regimens for personalized hepatitis C treatment and increasing options to treat hepatitis B.”
 
Bristol-Myers Squibb is studying a portfolio of compounds that has the potential to address unmet medical needs for patients with liver disease, including the investigational compounds daclatasvir, asunaprevir and BMS-791325 for HCV, and Lambda for HCV and HBV. In addition to these compounds, the Company’s medicine BARACLUDE® (entecavir) is approved for the treatment of chronic hepatitis B (CHB) in adults with evidence of active viral replication and either evidence of persistent elevations in aminotransferases (ALT or AST), or histologically active disease.
The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the ILC/EASL website at http://www.easl.eu/_the-international-liver-congress/general-information.

Title   Date/Time
Hepatitis C: Direct-Acting Antiviral Data
     
Synergistic Interactions of HCV NS5A replication Complex Inhibitors Sensitize Resistant Variants and Enhance the Efficacy of Daclatasvir (DCV, BMS-790052) In Vitro and In Vivo
  April 25
12:15 – 1:30 pm
Asunaprevir with Peginterferon and Ribavirin in Treatment-Naïve Patients with Genotype –1 or -4 Chronic Hepatitis C: SVR24 Results From a Randomized Phase 2b Study (AI447016)   April 25
12:15 – 1:30 pm
Evaluation of Pharmacokinetic Drug-Drug Interaction (DDI) Between BMS-791325, an NS5B Non-Nucleotide Polymerase Inhibitor, Daclatasvir and Asunaprevir in Triple Combination in HCV Genotype 1-Infected Patients   April 25
12:15 – 1:30 pm
The Effect of Coadministration of the Proton-Pump Inhibitor Omeprazole on the Pharmacokinetics of Daclatasvir in Healthy Subjects   April 26
12:30 – 2:00 pm
Exposure-Response Analyses of Asunaprevir in Combination with Daclatasvir ± Peginterferon / Ribavirin Among Patients with Genotype 1 Chronic HCV Infection: Dose Selection for Phase 3 Clinical Trials
-Response Analyses of Asunaprevir in Patients with Genotype 1, Chronic HCV Infection: Dose Selection for Phase 3 Clinical Trials
  April 26
12:30 – 2:00 pm
Daclatasvir Combined With Peginterferon Alfa and Ribavirin for 12 or 16 Weeks in Patients With HCV Genotype 2 or 3 Infection: COMMAND GT2/3 Study
  April 27
3:30 – 5:30 pm
Oral presentation
Sustained Virologic Response with Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) In Chronic HCV Genotype (GT) 1-Infected Patients who Previously Failed Telaprevir (TVR) or Boceprevir (BOC)   April 27
3:30 – 5:30 pm
Oral presentation
Safety Profile of Daclatasvir in Combination with Peginterferon Alfa and Ribavirin in 1100 Patients with Chronic HCV Infection Treated in Phase 2 Studies   April 27
12:30 – 1:30 pm
Pre-Existence, Emergence and Persistence of HCV Genotype 4 NS5A Resistance Variants from the Phase 2b COMMAND-1 Study: Daclatasvir Plus Peginterferon-Alfa/Ribavirin in Treatment-Naïve Patients
  April 27
12:30 – 1:30 pm
Hepatitis C: Outcomes Research Data
Host Genetic Variants Around IL28A/IL28B Associated with HCV-Related Outcomes Based on R.E.V.E.A.L.-HCV Cohort
  April 25
12:15 – 1:30 pm
Genome-Wide Association Study to Identify Potential Single Nucleotide Polymorphisms Associated with Spontaneous Hepatitis C Virus Clearance Among Chronic Hepatitis C Patients
  April 25
12:15 – 1:30 pm
Hepatitis B: Peginterferon Lambda-1a Data
ALT Flares During Treatment With Peginterferon Lambda or Peginterferon Alfa in Patients with HBeAg-Positive Chronic Hepatitis B Infection (CHB)   April 26
12:30 – 2:00 pm
Hepatitis B: BARACLUDE® (entecavir) Data
Impact of Entecavir Versus Lamivudine on Hepatic Covalently Closed-Circular DNA and Total Hepatic HBV DNA in Nucleoside-Naïve HBeAg Positive Chronic Hepatitis B Patients   April 26
12:30 – 2:00 pm
 
Read Complete Press Release Here

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