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GLOBE Trial 2-Year Data Shows Telbivudine (Tyzeka) Is More Effective than Lamivudine (Epivir-HBV) for Chronic Hepatitis B

Several nucleoside/nucleotide analog agents have activity against hepatitis B virus (HBV), but the development of drug resistance can be a barrier to long-term treatment success. Newer agents, however, appear to produce more durable benefit than the old standard-of-care, lamivudine (Epivir-HBV). Telbivudine (Tyzeka) was approved by the U.S. Food and Drug Administration in October 2006. Approval was based in part on 52-week data from the pivotal GLOBE trial. Follow-up continued, and now 104-week safety and efficacy findings have been published in the February 2009 issue of Gastroenterology.

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Adefovir (Hepsera) Prevents Post-transplant HBV Recurrence as well as HBIG

Liver transplantation is the only treatment for end-stage liver failure due to chronic hepatitis B virus (HBV) infection, but without preventive therapy, the virus typically quickly attacks the new liver, which can lead to complications, organ failure, and death.

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Association between Hepatitis B and C Virus Infection and Extrahepatic Bile Duct Cancer

It is well known that chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) can lead to advanced liver disease, including hepatocellular carcinoma (a form of primary liver cancer) over the course of years or decades. Now, a new study published in the April 15, 2008 International Journal of Cancer indicates that viral hepatitis may also promote development of cancer of the extrahepatic bile duct, which transports bile from the liver to the small intestine, joining with a similar duct from the gall bladder.

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Adding Ribavirin Does Not Improve Response to Pegylated Interferon Therapy for Chronic Hepatitis B

In a poster presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008) last week in San Francisco, researchers reported results from a study assessing whether addition of ribavirin improves response in hepatitis B patients.

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EASL 2008: Sorafenib (Nexavar) Improves Outcomes in Patients with Hepatocellular Carcinoma

In a late-breaker presentations at the 43rd annual meeting of the European Association for the Study of the Liver (EASL 2008) last month in Milan, researchers discussed data from the SHARP study, which evaluated sorafenib (Nexavar) as a therapy for HCC. Sorafenib, which was already approved for primary kidney cancer, recently received U.S. Food and Drug Administration (FDA) approval for unresectable (not curable by surgery) HCC.


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Two Studies Look at Promising Therapies for Liver Cancer: Sorafenib and Doxorubicin

Two recently published studies produced promising data on experimental therapies for HCC: the systemic chemotherapy drug sorafenib (Nexavar), and combination therapy using doxorubicin-eluting beads plus radiofrequency ablation.


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Canadian Health Officials Warn against Use of Tebivudine (Tyzeka/Sebivo) in Combination with Interferons

Officials with Health Canada issued a warning last week that the recently approved anti-HBV drug telbivudine (marketed as Tyzeka in the U.S. and as Sebivo elsewhere) should not be used in combination with any type of interferon due to the risk of additive side effects. Conventional interferon alfa-2b (Intron-A) and pegylated interferon alfa-2a (Pegasys) are currently approved as treatments for chronic hepatitis B.

Below is a report from the Canadian Press describing the recent announcement:

Taking hepatitis B drug with interferon potentially dangerous: Health Canada

Health Canada is warning consumers being treated with telbivudine (Tyzeka/Sebivo) for hepatitis B not to combine the medication with any interferon products because of potentially serious drug interactions.

Taking both telbivudine and interferon may increase the risk of peripheral neuropathy, a potentially serious condition characterized by weakness, numbness, tingling and burning sensations in the arms and/or legs.

Telbivudine is authorized by Health Canada and by the FDA in the U.S. for use as monotherapy, not for use in combination with any interferon products, including standard or pegylated types of interferon alfa (e.g., Pegasys, PegIntron, Intron A, Roferon A, and Infergen) and of interferon beta (marketed under brand names such as Rebif, Betaseron, and Avonex).

The drug's manufacturer, Novartis Pharmaceuticals Canada Inc., said that in a small clinical trial testing the use of both telbivudine and Pegasys (peginterferon alfa-2a), serious peripheral neuropathy occurred in five out of 48 patients (10 percent), and was occasionally disabling. The condition usually started about three months after initiation of treatment.

Health Canada said Wednesday it is not yet known if this adverse event is reversible once treatment is stopped, or whether it might also occur when the drug is used with interferon products other than Pegasys.

Consumers are advised to tell their doctors if they are taking telbivudine and an interferon product, but should not discontinue or modify telbivudine without first consulting their physician, due to the risk of worsening the hepatitis B infection.

Peripheral neuropathy has been reported in five out of 2,000 patients (less than one percent) using telbivudine alone in clinical trials. The disorder also is a common adverse side effect of Pegasys (reported on average in one to five out of 100 patients in clinical trials).

Consumer information for telbivudine is being updated and Novartis has issued a letter to health professionals advising them of the new safety information.



Canadian Press (via Yahoo News). Taking hepatitis B drug with interferon potentially dangerous: Health Canada. March 12, 2008.

Association between ALT and HBV DNA Viral Load in Chronic Hepatitis B Patients Treated with Pegylated Interferon

Association between ALT and HBV DNA Viral Load in Chronic Hepatitis B Patients Treated with Pegylated Interferonaminotransferase (ALT) is a key indicator of liver inflammation in individuals with chronic hepatitis B virus (HBV) infection. During interferon-based therapy, approximately 25%-40% of patients experience ALT "flares" (sudden increases), but the relationship between ALT level and treatment outcome is not well understood.

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Long-term Adefovir (Hepsera) plus Emtricitabine (Emtriva) vs Adefovir Monotherapy for Chronic Hepatitis B

Antiviral therapy with nucleoside/nucleotide analog agents is effective against chronic hepatitis B virus (HBV) infection, but long-term efficacy is limited by the emergence of drug resistant virus. As reported in the May 2008 Journal of Hepatology, researchers from the University of Hong Kong conducted a trial to determine the efficacy of adefovir dipivoxil (Hepsera) plus emtricitabine (Emtriva) combination therapy in patients with chronic hepatitis B. Adefovir is currently approved for this indication; emtricitabine is approved for the treatment of HIV, but is still under investigation for HBV.

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