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COMPANY

STATUS

FAMILY/DRUG NAME

MECHANISM

COMPANY

STATUS

Interferons - Mimic naturally-occurring, infection-fighting immune substance produced in the body

Intron A
(Interferon
alfa-2b

Immunomodulator

Merck,
Whitehouse Station, NJ

FDA Approved
1991

Pegasys
(Peginterferon alfa-2a)

Immunomodulator

Genentech,
South SanFrancisco, CA

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

Novartis,
Switzerland

FDA Approved
2006

Viread
(Tenofovir)

Inhibits viral DNA polymerase

Gilead
Foster City, CA

FDA Approved 2008

Clevudine
(L-FMAU)

Inhibits viral DNA polymerase

Bukwang
South Korea
Eiasai, Japan

Approved S. Korea
2006 (Levovir)

Besifovir (LB80380)

Inhibits viral DNA polymerase

LG Life Sciences,
S. Korea

Phase II

AGX-1009

Prodrug of Tenofovir

Agenix, Australia

Phase I, China

Non-Nucleoside Antivirals -  Interfere with proteins involved in viral reproduction

NOV-205
(BAM 205)

Small Molecule

Novelos
Newton, MA

Approved in Russia

Myrcludex B

Entry Inhibition

Myr-GmbH,
Germany

Phase IIa, Russia

HAP Compound
Bay 41-4109

Inhibits viral nucleocapsid

AiCuris, Germany

Phase I

REP 9AC     

HBsAg Release Inhibitor

REPLICor Inc.
Montreal, Quebec

Phase I

Alinia (Nitazoxanide)

Small Molecule

Romark Labs
Tampa, FL

Preclinical

dd-RNAi compound

Gene silencing

Benitec, Australia
and Biomics, China

Preclinical

ARC-520

RNAi gene silencer

Arrowhead Research, Pasadena, CA

Clinical Phase I

NVR-1221

Capsid inhibitor

Novira Therapeutics, Doylestown, PA

Preclinical

IHVR-25

cccDNA inhibitor

Baruch S. Blumberg Intsitute,
Doylestown, PA

Preclinical

Non-Interferon Immune Enhancers -  Boost T-cell infection-fighting immune cells and natural interferon production

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

GS-9620

TLR7 agonist

Gilead
Foster City, USA

Phase I

GI13000

HBV Antigen

Globe Immune
Louisville, CO

Preclinical with Gilead

Immunomodulator

Merck,
Whitehouse Station, NJ

FDA Approved
1991

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