HBF Drug Watch

Compounds in Development for Chronic Hepatitis B

Updated April 2010

FAMILY/DRUG NAME	MECHANISM	COMPANY	STATUS
Interferons - Mimic naturally-occurring, infection-fighting immune substance produced in the body
Intron A (Interferon alfa-2b	Immunomodulator	Schering-Plough Madison, NJ	FDA Approved 1991
Pegasys (Peginterferon alfa-2a)	Immunomodulator	Roche Switzerland	FDA Approved 2005
There are other brands of interferon approved for HCV treatment, but they have not been FDA-approved for HBV: Wellferon (Glaxo), Roferon(Hoffman-La Roche), and Infergen (Amgen)
Nucleoside Analogues - Interfere with the viral DNA polymerase enzyme used for hepatitis B virus reproduction
Epivir-HBV (Lamivudine)	Inhibits viral DNA polymerase	GlaxoSmithKline Philadelphia, PA	FDA Approved 1998
Hepsera (Adefovir Dipivoxil)	Inhibits viral DNA polymerase	Gilead Foster City, CA	FDA Approved 2002
Baraclude (Entecavir)	Inhibits viral DNA polymerase	Bristol-Myers Squibb Princeton, NJ	FDA Approved 2005
Tyzeka Sebivo (Europe) (Telbivudine)	Inhibits viral DNA polymerase	Idenix Cambridge, MA	FDA Approved 2006
Viread (Tenofovir)	Inhibits viral DNA polymerase	Gilead Foster City, CA	FDA Approved 2008
Emtricitabine (FTC)	Inhibits viral DNA polymerase	Gilead Foster City, CA	Phase III
Clevudine (L-FMAU)	Inhibits viral DNA polymerase	Bukwang South Korea Eiasai, Japan	Approved S. Korea 2006 (Levovir)
Amdoxovir (DAPD)	Inhibits viral DNA polymerase	RFS Pharm LLC Tucker, GA	Phase II
Non-Nucleoside Antivirals - Interfere with proteins involved in viral reproduction
NOV-205 (BAM 205)	Small Molecule	Novelos Newton, MA	Approved in Russia
LB80380 (ANA380)	Inhibits viral RNA polymerase	LG Life Sciences, S. Korea	Phase II
Nitazoxanide (Alinia)	Small Molecule	Romark Labs Tampa, FL	Phase II Egypt
HAP Compound Bay 41-4109	Inhibits viral nucleocapsid	AiCuris, Germany	Phase I
Nitazoxanide (Alinia)	Small Molecule	Romark Labs Tampa, FL	Preclinical for HBV
Non-Interferon Immune Enhancers - Boost T-cell infection-fighting immune cells and natural interferon production
EHT899	Oral Viral Protein	Enzo Biochem New York, N.Y.	Phase II Israel
Zadaxin (Thymosin alpha-1)	Immune stimulator	SciClone San Mateo, CA	Orphan drug approval in US for liver cancer
CYT107 (Interleukin-7)	Immunemodulator	Cytheris, Paris, France	Phase I/IIa
DV-601	HBV surface and core antigens	Dynavax, Berkeley, CA	Phase Ib
HBV Core Antigen Vaccine	Therapeutic HBV vaccine	Emergent Europe, U.K.	Phase I
Post-Exposure and/or Post-Liver Transplant Treatment
HyperHEP S/D	HBV Immuneglobulin	Talecris RTP, NC	FDA Approved 1977
Nabi-HB	HBV Immuneglobulin	Nabi Boca Raton, FL	FDA Approved 1999
Hepa Gam B	HBV Immuneglobulin	Cangene Canada	FDA Approved 2006

Page last modified April 7, 2010