FAMILY/DRUG NAME | MECHANISM | COMPANY | STATUS |
Interferons - Mimic naturally-occurring, infection-fighting immune substances produced in the body |
Intron A
(Interferon
alfa-2b) |
Immunomodulator |
Merck,
Whitehouse Station, NJ |
FDA Approved
1991 |
Pegasys
(Peginterferon alfa-2a) |
Immunomodulator |
Genentech,
South San Francisco, 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 Sciences,
Foster City, CA |
FDA Approved
2002 |
Baraclude
(Entecavir) |
Inhibits viral DNA polymerase |
Bristol-Myers
Squibb,
Princeton, NJ |
FDA Approved
2005
|
Tyzeka
(Telbivudine) |
Inhibits viral DNA polymerase |
Novartis,
Switzerland |
FDA Approved
2006 |
Viread
(Tenofovir) |
Inhibits viral DNA polymerase |
Gilead Sciences,
Foster City, CA |
FDA Approved 2008 |
Clevudine
(L-FMAU) |
Inhibits viral DNA polymerase |
Bukwang,
South Korea
Eisai, Japan |
Approved S. Korea
2006 (Levovir) |
Tenofovir alafenamide (TAF)
|
Prodrug of Tenofovir |
Gilead Sciences,
Foster City, CA |
Phase III |
CMX157 |
Prodrug of Tenofovir |
ContraVir Pharmaceuticals,
Edison, NJ |
Phase II |
AGX-1009 |
Prodrug of Tenofovir |
Agenix, Australia |
Phase I, China |
Non-Nucleoside
Antivirals - Interfere with proteins
involved in viral reproduction |
Myrcludex B |
Entry Inhibition |
Hepatera, Russia with Myr-GmbH, Germany |
Phase II for HBV and HDV |
ARC-520 |
RNAi gene silencer |
Arrowhead Research, Pasadena, CA |
Phase IIa |
NVR-1221
(NVR 3-778) |
Capsid inhibitor |
Novira Therapeutics, Doylestown, PA |
Phase IIa |
HAP Compound
Bay 41-4109 |
Inhibits viral nucleocapsid |
AiCuris,
Germany |
Phase I |
Birinapant
(TL32711) |
SMAC inhibitor |
TetraLogic,
Malvern, PA
|
Phase I/IIa |
TKM-HBV |
HBsAg inhibitor |
Tekmira,
Canada
|
Phase I |
SB 9200 |
Small molecule nucleic acid hybrids or “SMNH” |
Spring Bank Pharma,
Milford, MA
|
Phase II |
REP 9AC |
HBsAg Release Inhibitor |
REPLICor Inc.,
Canada |
Phase I |
Alinia (Nitazoxanide) |
Small Molecule |
Romark Labs,
Tampa, FL |
Preclinical |
dd-RNAi compound |
Gene silencing |
Benitec, Australia and Biomics, China |
Preclinical |
BSBI-25 |
cccDNA inhibitor |
Baruch S. Blumberg Institute, Doylestown, PA |
Preclinical |
ALN-HBV |
RNAi gene silencer |
Alnylam,
Cambridge, MA
|
Preclinical |
CPI-431-32 |
Cyclophilin inhibitor |
Ciclofilin Pharma,
San Diego, CA
|
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 |
ABX 203 |
Therapeutic vaccine |
ABIVAX,
Paris, France |
Phase IIb/III |
GS-4774 |
Therapeutic vaccine |
Gilead Sciences with Globe Immune,
Louisville, CO |
Phase II |
GS-9620 |
TLR7 agonist |
Gilead Sciences,
Foster City, CA |
Phase II |
CYT107
(Interleukin-7) |
Immunemodulator |
Cytheris,
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 |
INO-1800 |
Therapeutic vaccine |
Inovio,
Blue Bell, PA |
Preclinical |
TG 1050 |
Immunotherapeutic |
Transgene,
Shanghai |
Preclinical |
Post-Exposure
and/or Post-Liver Transplant Treatment |
HyperHEP B S/D |
HBV Immuneglobulin |
Grifols, RTP, NC |
FDA Approved 1977 |
Nabi-HB |
HBV Immuneglobulin |
Biotest,
Boca Raton, FL |
FDA Approved
1999 |
Hepa Gam B |
HBV Immuneglobulin |
Cangene
Canada |
FDA Approved 2006 |