New Treatment for Chronic Hepatitis B in Adults 

On October 25, 2006, the Food and Drug Administration (FDA) approved a new drug, Tyzeka (telbivudine), for the treatment of chronic hepatitis B (HBV) in adults.  Telbivudine is a nucleoside analogue designed to suppress viral replication and improve liver function in adults with chronic HBV and elevated serum aminotransferase levels.  Approximately 70,000 Americans will become infected with chronic HBV per year, and about 5,000 of those patients will die of complications.  Currently, telbivudine is one of only five medications approved for the treatment of chronic HBV.  Marketing approval of telbivudine in the United States was based on a clinical trial evaluating over 1,300 patients over the age of 16 years old with chronic HBV.  The study compared telbivudine 600 mg once daily to lamivudine 100 mg daily and found comparable effectiveness.  The most common adverse events reported were elevated creatinine phosphokinase (CPK), upper respiratory tract infections, fatigue, malaise, headache, abdominal pain, nausea and vomiting, nasal congestion, and cough.  The FDA reported some patients experienced muscle pain or weakness after weeks to months of therapy.  The muscle pain or weakness stopped after the medication was discontinued.  Telbivudine is not a cure for hepatitis B, and the long-term benefits and risks of the drug are still unknown. 

Tyzeka (telbivudine) will be manufactured by Novartis Pharmaceuticals Stein AG, Stein, Switzerland.  The drug will be marketed and distributed by Identix Pharmaceuticals, Inc., Cambridge, MA.  The two companies are co-promoting this product under a development and commercialization agreement established in May 2003.  Neither company has announced when Tyzeka will become available in the United States.

References:

1. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01498.html
2. http://www.ashp.org/news/ShowArticle.cfm/id=17340
3. http://www.novartis.com
4. http://biz.yahoo.com/prnews/061025/nyw190.html?.v=29

Carrie M. Simpson, Pharm.D. Candidate