Bristol-Myers Squibb Co Undergoes Major US Business Revamp

Bristol-Myers Squibb Co (NYSE:BMY) announced Thursday it will be halting early-stage discovery work in virology research, including hepatitis B and HIV. The company will be laying off around 100 employees as it shuts down two research centers.

"Consistent with the evolution of the company's R&D strategic focus, which was announced in 2013, the Discovery organization will discontinue its research efforts in virology. This includes early research in hepatitis B (HBV) and HIV...Approximately 100 Discovery positions will be eliminated as a result of these changes,” the company stated.

Bristol-Myers, however, noted that ongoing development work on advanced virology treatments including HIV attachment inhibitor BMS-663068, the HIV maturation inhibitor BMS-955176, beclabuvir and the anti-PD-L1 compound BMS-936559, will continue. Also, the company’s marketed virology drugs such as Baraclude (entecavir), Reyataz (atazanavir)/Evotaz (atazanavir and cobicistat), Sustiva (efavirenz), Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), Daklinza (daclatasvir) and Sunvepra (asunaprevir), will not be affected by the consolidation.

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Liver transplants in HIV/HCV co-infection: study underlines importance of hepatitis C treatment

People with HIV and hepatitis C co-infection were significantly more likely to experience organ rejection than people with hepatitis C alone or HIV alone after undergoing a liver transplant, according to a review of 11 years' experience of liver transplantation in people with HIV and with hepatitis C virus (HCV) in the United States, published in advance online in the journal Clinical Infectious Diseases.

The study investigators say that their findings underline the importance of treating hepatitis C either before or immediately after liver transplantation in order to improve outcomes, rather than assuming that people with co-infection will have poorer outcomes based on historical data.

Liver transplantation remains a relatively rare procedure among people living with HIV, due in part to concerns about poorer survival and higher rates of organ rejection in people with HIV. Although a study carried out by the United States National Institutes of Health (NIH) showed a somewhat lower rate of survival three years after transplantation and a higher rate of organ rejection in people with HIV and hepatitis C co-infection compared to people with hepatitis C alone (mono-infection), the majority of transplants in each group was successful. The success of transplantation in people with HIV who are not do not have hepatitis C co-infection has been unclear. Furthermore, data are lacking outside the clinical trial setting regarding the outcomes of transplants in people with co-infection, particularly at transplant centres which did not take part in the NIH trial.

Reference

Sawinski D et al. Beyond the NIH Multicenter HIV Transplant Trial experience: outcomes of HIV+ liver transplant recipients compared to HCV+ or HIV+/HCV+ co-infected recipients in the United States. Clin Infect Dis, advance online publication, 16 June 2015.

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AASLD Updates Guidance for Use of Hepatitis C Drugs

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AASLD Updates Guidance for Use of Hepatitis C Drugs

The American Association for the Study of Liver Diseases (AASLD), in partnership with the Infectious Diseases Society of America (IDSA) and in collaboration with the International Antiviral Society-USA (IAS-USA), created online Recommendations for Testing, Managing, and Treating Hepatitis C in 2014 to aid practitioners treating patients infected with hepatitis C virus (HCV). Now an update to the Guidance, with a summary of recommendations regarding treatment with direct-acting antiviral drugs, is published in the AASLD journal, Hepatology.

HCV is a blood-borne virus that infects the liver and may lead to cirrhosis or liver cancer (hepatocellular carcinoma). In the past 25 years HCV has gone from an undiagnosed disease to an epidemic level, with the World Health Organization (WHO) estimating that up to 150 million people worldwide live with chronic disease.

In the U.S., close to 30,000 new acute cases were reported in 2013 and 2.7 million Americans have chronic HCV according to the Centers for Disease Control and Prevention (CDC). “The good news is that HCV is now on the cusp of being a curable disease for the millions of Americans, many of whom are undiagnosed,” says Dr. Gary Davis, President of MedLogician Consulting and co-chair of the AASLD/IDSA HCV Guidance writing panel. “The web-based Guidance document is an easy-to-use resource for practitioners treating HCV patients with novel antivirals.”

A panel of 26 hepatologists and infectious diseases specialists and a patient advocate developed the original consensus recommendations that include:

• HCV testing details and linkage to care
• Recommendations for initial treatment of HCV infection in patients starting treatment
• Retreatment information in persons in whom prior therapy has failed
• Unique patient populations data

 
“The Guidance is a living document that will continually be updated with evidence-based advice about how to best use the next generation of direct-acting antivirals and other treatment options,” comments Dr. Keith Lindor from the Arizona State University and President-elect of AASLD. “Our role as associations of researchers and clinicians is to provide key information in the appropriate format to patients and those who care for them.”
 
Practitioners involved with treating patients with liver disease may access the Guidance, including new updates, at www.HCVGuidelines.org.

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Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.) Full citation:"Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus." Authors on behalf of the Hepatitis C Guidance Panel (see AASLD/IDSA HCV Guidance panel members and authors). Hepatology; Published Online: June 25, 2015, (DOI: 10.1002/hep.27950).

URL: http://doi.wiley.com/10.1002/hep.27950

About the Journal
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published by Wiley on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://wileyonlinelibrary.com/journal/hep.

About Wiley
Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content.

AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis

- 100 percent SVR(12) rate achieved with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin(1) 

Jun 24, 2015

NORTH CHICAGO, Ill., June 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR₁₂) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.¹ Patients received 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV). These new results from AbbVie's Phase 3b study will be presented at the 15^th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin, Germany.

Approximately 160 million people worldwide are infected with HCV.² Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide³ and in Europe, the most prevalent genotype is 1b (47 percent).⁴ Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 percent of people infected.²

"Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens," said Jordan J. Feld, M.D., MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. "The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks."

Patients in TURQUOISE-III were either treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). No patients discontinued treatment due to adverse events.¹ The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).¹

"In the TURQUOISE-III study, GT1b patients with compensated liver cirrhosis achieved a 100 percent cure rate with VIEKIRAX + EXVIERA without ribavirin," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "TURQUOISE-III is part of our Phase 3b program, which aims to further enhance our understanding of AbbVie's regimen in HCV populations seen in clinical practice, and supports our commitment to continued investigation in this field."

About TURQUOISE-III Study
TURQUOISE-III is a multi-center, open-label Phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with VIEKIRAX® + EXVIERA® without ribavirin (RBV) in adult patients (n=60) with genotype 1b chronic hepatitis C virus infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR₁₂).¹

No patients experienced virologic failure during treatment and no patients experienced virologic relapse following the end of treatment.¹

About VIEKIRAX® + EXVIERA® VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

About AbbVie's HCV Clinical Development ProgramThe AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with or without ribavirin with the goal of achieving high sustained virologic response rates in as many patients as possible. AbbVie's global Phase 3b program plans to include more than 2,800 genotype 1 patients in over 200 study centers worldwide, including the U.S., Canada, Europe, Russia and Brazil.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

VIEKIRAX® + EXVIERA® EU IndicationVIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Important EU Safety Information
 
Contraindications:VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.

Special warnings and precautions for use:VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.

Pregnancy and concomitant use with ribavirinWhen VIEKIRAX + EXVIERA are used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and 6 months after the treatment. Refer to the Summary of Product Characteristics for ribavirin for additional information.

ALT elevationsTransient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.

Use with concomitant medicinal productsUse caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.

Adverse ReactionsMost common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.

Full summary of product characteristics is available at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

¹ Feld J, et al. TURQUOISE-III: Safety and Efficacy of 12-week Ribavirin-free Treatment for Patients with HCV Genotype 1b and Cirrhosis. Presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD) in Berlin, Germany, June 26-28, 2015
² Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15
³ Global Alert and Response (GAR): Hepatitis C. World Health Organisation Web site. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html#HCV. Published 2003. Accessed November, 2013
⁴ O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1. Philadelphia, PA: Saunders Elsevier. 2010:1313-1335

SOURCE AbbVie

For further information: Media, Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com, or Carlos Taveras, +33 1 41 73 92 64, carlos.taveras@abbvie.com, or Investor Relations, Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

Study Identifies Characteristics of Patients Likely to have a Potential Living Liver Donor

For Immediate Release
Media Contacts:
Dawn Peters (US) +1 781-388-8408
Tom Griffin (UK) +44 (0) 1865 476213
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New research published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, reports that younger patients, those who are married, and those with Child-Pugh C disease—the most severe measure of liver disease—are more likely immigrants, divorced patients and those at the lowest income levels [and] were less likely to have a potential live donor volunteer for liver donation.
 
With a limited supply of deceased donor organs, livers from living donors provide a much needed, life-saving option for those with end-stage liver disease. Despite evidence suggesting that the 5-year recipient survival from the time of wait listing is estimated to be 20% higher with a live donor compared with deceased donor, living donor liver transplantation accounts for only a few percent in many Western countries.

“Given that the demand for liver transplantation is greater than the supply of deceased donor organs, there is an interest in increasing live donation at centers with experience in that method of transplantation,” explains lead author Dr. Eberhard Renner with the University Health Network and University of Toronto in Ontario, Canada. “Our study aims to identify recipient characteristics that are associated with having a living donor volunteer for donation.”

The research team reviewed data from 491 patients listed for liver transplantation at the University transplant center over a 24-month period. There were 245 patients identified who had a least one potential living donor with 70% of these recipients being male and having an average age of 53 years at wait listing. Hepatitis C, alcoholic liver disease and hepatocellular carcinoma were listed as reason for liver transplant in 34%, 20%, and 35% of cases in the study group.

Analyses found that recipients who had potential access to a living donor were more likely to have more severe liver disease (Child-Pugh C). The recipients were less likely to be older, single, divorced, immigrants or from the lowest income levels. Commenting about the findings Dr. Renner says, “More research is needed to understand and overcome the barriers to live donor liver transplants. Possible interventions like financial assistance and educational programs may help increase liver donation from living donors.”

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Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.) Full citation: "Recipient Factors Associated with Having a Potential Live Liver Donor.” Adam Doyle, Rania N. Rabie, Arastoo Mokhtari, Mark Cattral, Anand Ghanekar, David Grant, Paul Greig, Gary Levy, Leslie Lilly, Ian McGilvray, Markus Selzner, Nazia Selzner and Eberhard L. Renner. Liver Transplantation; (DOI: 10.1002/lt.24148).

URL: http://doi.wiley.com/10.1022/lt.24148
Author Contact: Media wishing to speak with Dr. Renner may contact Alexandra Radkewycz with Toronto General Hospital, University Health Network at Alexandra.Radkewycz@uhn.ca.

About the Journal
Liver Transplantation is published by Wiley on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AASLD and the ILTS, Liver Transplantation delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit http://wileyonlinelibrary.com/journal/lt.

About Wiley
Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content.

VA to outsource care for 180,000 vets with hepatitis C

PHOENIX — The Department of Veterans Affairs is moving to outsource care nationwide for up to 180,000 veterans who have hepatitis C, a serious blood and liver condition treated with expensive new drugs that are costing the government billions of dollars.

The VA has spent weeks developing a dramatic and controversial transition as patient loads have surged and funding has run out. Those efforts were not disclosed until records were released this week to The Arizona Republic.

Instructions on how to carry out the program show that the sickest veterans generally will get top priority for treatment. However, patients who have less than a year to live or who suffer "severe irreversible cognitive impairment" will not be eligible for treatment.

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Canada: Ontario urged to provide better access to breakthrough hepatitis C drugs

People infected with potentially fatal hepatitis C from tainted blood are pushing Ontario to make them whole by paying for expensive breakthrough drugs considered a virtual cure for the liver disease.

Ontario’s health ministry says 341 Ontarians with stage-two liver disease or worse get Sovaldi or Harvoni pills funded by taxpayers — $60,000 for a 12-week course — under an exceptional access program.

The medications are light-years ahead of previous pharmaceuticals that had troubling side effects and did not work nearly as well.

Doctors say the triage system, in which a FibroScan (a non-invasive liver test) must meet or exceed a specific level of liver damage, can miss patients with complications that would otherwise make them eligible for taxpayer coverage.

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