Bristol-Myers Squibb to Present Data from Multiple Studies of Difficult-to-Treat Chronic Hepatitis C Patients at AASLD

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.--()--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:

  • 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.
  • 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/.

Title     Date/Time

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

   

Session: Late-breaking Abstract Session

Date: November 16, 2015

Session Time: 3:00 – 4:30 p.m.

Publication Number: LB-3

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

   

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

Oral Presentation: Daclatasvir plus sofosbuvir with or without ribavirin in genotype 3 patients from a large French multicenter compassionate use program

   

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

Oral Presentation: Daclatasvir and Sofosbuvir in Patients with Recurrent HCV Following Liver Transplantation and Advanced Fibrosis or Cirrhosis: United States Multicenter Treatment Protocol

    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

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

    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

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)

    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

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

    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

Poster: Improvement in liver disease parameters following treatment with daclatasvir + sofosbuvir and ribavirin in patients with chronic HCV infection and advanced cirrhosis

   

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

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

   

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

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

    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

Poster: An integrated safety analysis of daclatasvir + sofosbuvir, with or without ribavirin, in patients with chronic HCV infection

   

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

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

 

   

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

Poster: Integrated Safety Analysis of Daclatasvir Plus Sofosbuvir, With or Without Ribavirin, in Patients With HCV Genotype 3 Infection

    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

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

   

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

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

 

   

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

Poster: Impact of Daclatasvir-Sofosbuvir Combination Treatment on Medical Events and Costs in Patients Infected with Genotype 3 Hepatitis C Virus

    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

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

    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

   

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:
    • 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.

  • 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.
    • 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.
    • Bradycardia generally resolved after discontinuation of HCV treatment.
    • 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

  • 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.

Contacts

Bristol-Myers Squibb Company
Media:
Robert Perry, 609-419-5378
Cell: 407-492-4616
rob.perry@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Bill Szablewski, 609-252-5894
william.szablewski@bms.com

Contacts

Bristol-Myers Squibb Company
Media:
Robert Perry, 609-419-5378
Cell: 407-492-4616
rob.perry@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Bill Szablewski, 609-252-5894
william.szablewski@bms.com