THERAPIES FOR HEPATITIS B (Provided by Ron Baker of HIVandHepatitis.com)

Although patients with chronic hepatitis B currently have only two FDA-approved options for therapy, one new drug (adefovir dipivoxil) is now available to individuals with lamivudine-resistant HBV. In addition, there are now three new drugs in Phase III testing (adefovir, emtricitabine and entecavir, nine new drugs in Phase II testing, three drugs in Phase I, and four drugs in pre-clinical testing. Following is a chart of therapies for chronic hepatitis B, with links that offer more information about them.

THERAPIES FOR HEPATITIS B Drug Name Drug Class Company FDA Status Intron A (interferon alfa-2b) interferon Schering-Plough FDA-approved Epivir-HBV (lamivudine; 3TC) nucleoside analogue GlaxoSmithKline FDA-approved Adefovir dipivoxil nucleotide analogue Gilead Sciences Phase III * NDA filed March 2002 Coviracil (emtricitabine; FTC) nucleoside analogue Triangle Pharmaceuticals Phase III Entecavir nucleoside analogue Bristol-Myers Squibb Phase III Clevudine (L-FMAU) nucleoside analogue Triangle Pharmaceuticals Phase II ACH 126, 443 (L-Fd4C) nucleoside analogue Achillion Pharmaceuticals Phase II AM 365 nucleoside analogue Amrad Phase II (Asia and Australia) DAPD nucleoside analogue Triangle Pharmaceuticals Phase II LdT (telbivudine) nucleoside analogue Idenix Phase II XTL 001 monoclonal antibody XTL Biopharm Phase II (Israel) Theradigm Immune stimulant Epimmune Phase II Zadaxin** (thymosin) Immune stimulant SciClone Phase II with Epivir-HBV EHT 899 viral protein Enzo Biochem Phase II (Israel) LdC nucleoside analogue Novirio Phase I HBV DNA vaccine Immune stimulant PowderJect (UK) Phase I MCC 478 nucleoside analogue Eli Lilly Phase I (Germany) vaILdC (Valtorcitabine) nucleoside analogue Idenix Phase I ICN 2001 nucleoside analogue ICN Preclinical Fluro L and D nucleosides nucleoside analogue Pharmasset Preclinical Racivir nucleoside analogue Pharmasset Preclinical Robustaflavone nucleoside analogue Advanced Life Sciences Preclinical BayHepB HBV immuneglobulin Bayer (US) FDA-approved anti-hepatitis B HBV immuneglobulin Cangene (Canada) NDA submitted 2001 Nabi-HB HBV immuneglobulin Nabi FDA-approved *Adefovir dipivoxil: now available to patients with lamivudine-resistant HBV through an Expanded Access Program. Physicians may call 1-800-GILEAD-5 or 1-650-574-3000. **Zadaxin: orphan drug approval in US Sources Hepatitis B Foundation Drug Watch. Compounds in Development for Hepatitis B. www.hepb.org Mark Nelson, MD. Selected Highlights from Drug Development for Antiretroviral Therapies 2001 (Hep DART 2001) December 16-20, 2001, Maui, Hawaii. New Medicines in Development. Pharmaceutical Research and Manufacturers of America.

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