The Food and Drug Administration (FDA), the government's drug regulatory agency, says its Antiviral Drugs Advisory Committee plans to review an application for approval of a potential medication for hepatitis B this spring.
The investigational drug, known as entecavir, has shown it's effective for HBV patients who show a resistance to lamivudine (Epivir-HBV/GlaxoSmithKline), a currently approved medicine for hepatitis B. That was demonstrated in three clinical trials whose findings were released late last year.1-3
The FDA panel is scheduled to review entecavir maker Bristol-Myers Squibb's new drug application on March 11. The pharmaceutical company is asking for approval of the nucleoside analog in both oral form and as a liquid solution. (Nucleoside analogs work by inhibiting production of an enzyme that helps the hepatitis B virus replicate.)
Statistics and Symptoms
Hepatitis B is caused by the hepatitis B virus. It's estimated that approximately 1.25 million Americans are chronically infected, but the number of new infections per year has plunged from an average of 260,000 in the 1980s to about 73,000 in 2003.
Symptoms include jaundice, fatigue, abdominal pain, loss of appetite, nausea and vomiting, and joint pain. However, nearly a third of infected people have no signs or symptoms of the disease.4
Currently available therapies for hepatitis B include interferon alfa-2b (Intron A/Schering-Plough), adefovir dipivoxil (Hepsera/Gilead Sciences) and lamivudine (Epivir-HBV/GlaxoSmithKline).
1. Shouval D, Lai CL, Cheinquer H et al. Entecavir demonstrates superior histologic and virologic efficacy over lamivudine in nucleoside-naïve HBeAg-negative chronic hepatitis B: results of phase II trial ETV-027. 55th Annual Meeting of the American Association for the Study of Liver Disease (AASLD). 2004 Oct 29-Nov2. Boston, MA.
2. Sherman M, Yurdaydin C, Sollano J et al. Entecavir is superior to continued lamivudine for the treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B: results of phase III study ETV-026. 55th Annual Meeting of the American Association for the Study of Liver Disease (AASLD). 2004 Oct 29-Nov2. Boston, MA.
3. Chang TT, Gish R, de Man R et al. Entecavir is superior to lamivudine for the treatment of HBeAg-positive chronic hepatitis B: results of phase III study ETV-022 in nucleoside-naïve patients. 55th Annual Meeting of the American Association for the Study of Liver Disease (AASLD). 2004 Oct 29-Nov2. Boston, MA.
4. Centers for Disease Control and Prevention (CDC). Viral Hepatitis B. Available at: http://www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm. Accessed February 2, 2005.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
