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European Commission Approves Labelling Update for BARACLUDE® (entecavir) in Liver Transplant Patients with Chronic Hepatitis B


News provided by

Bristol-Myers Squibb

05 Nov, 2012, 07:45 GMT

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-A Study provides further efficacy and safety data for BARACLUDE® in this special patient population-

PARIS, Nov. 5, 2012 /PRNewswire/ -- Bristol-Myers Squibb (NYSE: BMY) announced today that the European Commission (EC) has approved a BARACLUDE® (entecavir) Summary of Product Characteristics (SmPC) update based on new efficacy and safety data in patients with chronic hepatitis B (CHB) receiving a liver transplant.

"This labelling update is important news for patients receiving a liver transplant due to chronic hepatitis B complications," said Professor François Durand, MD, PhD, Hospital Beaujon, France, "It provides physicians with guidance on BARACLUDE's use in this difficult to treat population and adds additional information on its efficacy and safety profile".  

The labelling update was based on data from study ETV-109, investigating the efficacy and safety of BARACLUDE® 1 mg used once daily alone or with concomitant hepatitis B immunoglobulin (HBIg) in patients who received an orthotopic liver transplant (OLT) due to complications associated with hepatitis B (HBV) infection. At Week 72 post-transplant, none of 55 observed cases had virologic recurrence of HBV [defined as HBV DNA >/= 50 IU/ml (approximately 300 copies/ml)] and there was no reported virologic recurrence at time of censoring for the remaining 6 patients.

The frequency and nature of adverse events in this study were consistent with those expected in patients who have received a liver transplant and the known safety profile of entecavir.(1)

In Europe, CHB affects approximately 14 million people.(2) About 15-25% of people with chronic hepatitis B will develop serious liver problems, including cirrhosis, liver failure and liver cancer.(3) A liver transplant remains the only hope for patients with end-stage liver disease due to hepatitis B infection.(4) In Europe, 5-10% of all liver transplant cases are due to chronic or fulminant liver disease associated with chronic hepatitis B.(5)  Despite advances in treatment, in the absence of preventative antiviral therapies, post-liver transplant patients are still at risk of  HBV recurrence, therefore results of a liver transplant can sometimes be hampered. (6) Hepatitis B virus recurrence after liver transplant due to CHB may lead to graft failure, re-transplantation or death. (6)

About study AI463109
The safety and efficacy of entecavir 1 mg once daily were assessed in a single-arm study including 65 patients who received a liver transplant for complications of chronic HBV infection and had HBV DNA <172 IU/ml (approximately 1000 copies/ml) at the time of transplant.

The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years. HBeAg-negative disease at the time of transplant was reported in 89% of patients. Of the 61 patients who where evaluable for efficacy (received entecavir for at least 1 month), 60 also received hepatitis B immune globulin (HBIg) as part of the post-transplant prophylaxis regimen. Of these 60 patients, 49 received more than 6 months of HBIg therapy.

At Week 72 post-transplant, none of the 55 observed cases had virologic HBV recurrence of HBV [defined as HBV DNA >/= 50 IU/ml (approximately 300 copies/ml)] and there was no reported virologic recurrence at time of censoring for the remaining 6 patients.

 All 61 patients had HBsAg loss post transplantation, and 2 of these later became HBsAg positive despite maintaining undetectable HBV DNA (<6 IU/ml).

The frequency and nature of adverse events in this study were consistent with those expected in patients who have received a liver transplant and the known safety profile of entecavir.(1)      

About BARACLUDE®
BARACLUDE®, a nucleoside analogue discovered at Bristol-Myers Squibb, was approved by the European Commission in June 2006.

BARACLUDE® is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:

  • Compensated liver disease and evidence of active viral replication persistently elevated serum alanine aminotransferases (ALT) levels and histological evidence of active inflammation and/or fibrosis;
  •  Decompensated liver disease*.

In clinical studies the most common adverse reactions of any severity with at least a possible relation to entecavir were in patients with compensated liver disease: headache, fatigue, dizziness, nausea and reports of exacerbations of hepatitis during and after discontinuation of therapy; in patients with decompensated liver disease: peripheral edema, ascites, pyrexia, hepatic encephalopathy , and upper respiratory infection*.

* For full prescribing information for BARACLUDE®, please consult the Summary of Product Characteristics.

About Chronic Hepatitis B (CHB) and Liver Transplants
Chronic hepatitis B is a serious global health issue. Worldwide, more than two billion people have been in contact with the hepatitis B virus and approximately 350 million people are chronically infected. Chronic hepatitis B can cause chronic liver disease and puts people at high risk of death from cirrhosis of the liver and liver cancer. In some cases, a diagnosis is made too late and the only option is a liver transplant.(7)

A liver transplant is a surgical procedure that involves removing a person's failed liver, and replacing it with a healthy liver from a deceased donor (orthotopic transplant), or a graft from a living donor. Liver transplants are typically performed on patients who have chronic liver disease, such as viral hepatitis, acute liver failure, hepatic malignancy or a genetic disorder that affects the liver.(8)   

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.

BARACLUDE® (entecavir) is a registered trademark of Bristol-Myers Squibb.

References

  1. Baraclude Summary of Product Characteristics.
  2. Hepatitis. World Health Organization Regional Office for Europe. Available at http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/hepatitis. Accessed September 2012
  3. Centers for Disease Control and Prevention (CDC) Website. "Hepatitis B General Information." http://www.cdc.gov/hepatitis/HBV/PDFs/HepBGeneralFactSheet.pdf. Accessed September 18, 2012.
  4. Lok A. Liver transplantation for chronic hepatitis B virus infection, UpToDate, Wolters Kluwer Health. Available at http://www.uptodate.com/contents/liver-transplantation-for-chronic-hepatitis-b-virus-infection. Accessed September 2012
  5. Samuel D. Liver transplantation for chronic hepatitis B. Gastroenterol Clin Biol. 2008 Jan; 32 (1 Pt 2):S25-33. English Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18662607 . Accessed September 2012
  6. Carrion AF, et al; Management of Patients with Chronic Hepatitis B Before and After Liver Transplantation: An Update. Curr Hepatitis Rep (2012) 11:102-110 DOI 10.1007/s 11901-012-0128-4
  7. World Hepatitis Alliance. What is Viral Hepatitis? http://worldhepatitisalliance.org/AboutViralHepatitis/What_is_Viral_Hepatitis.aspx. Accessed September 2012
  8. Killackey MT, Florman S, Yu AS, et al. Orthotopic Liver Transplantation. Physicians' Information and Education Resource 2001. http://pier.acponline.org/mcpp/pdf/physpro992.pdf Accessed September 2012

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