Treatment Options

Approved Drugs for Adults

The future looks bright for individuals living with chronic hepatitis B. Only a decade ago there were no treatment options. Although there is still no complete cure for hepatitis B, there are 6 approved drugs for adults (2 for children) and many promising new drugs in development. Current treatments seem to be most effective in those who show signs of active liver disease

Not every person with chronic hepatitis B needs to be on medication. You should talk to your doctor about whether you are a good candidate for drug therapy or a clinical trial. Be sure that you understand the pros and cons of each treatment option.

Whether you decide to start treatment or not, it is very important to be seen by a liver specialist or doctor knowledgeable about hepatitis B on a regular basis.

Approved Hepatitis B Drugs in the United States

§ Interferon-alpha (Intron A) is given by injection several times a week for six months to a year, or sometimes longer. The drug can cause side effects such as flu-like symptoms, depression, and headaches. Approved in 1991 and available for both children and adults.

§ Pegylated Interferon (Pegasys) is given by injection once a week usually for six months to a year. The drug can cause side effects such as flu-like symptoms, depression and other mental health problems. Approved May 2005 for adults.

§ Lamivudine (Epivir-HBV, Zeffix, or Heptodin) is a pill that is taken once a day, with almost no side effects, for at least one year or longer. The possible development of hepatitis B virus mutants during and after treatment is a concern. Approved in 1998 and available for both children and adults.

§ Adefovir dipivoxil (Hepsera) is a pill taken once a day, with few side effects, for at least one year or longer. Kidney problems can occur while taking the drug and is a concern, but are reversible once the drug is stopped. Approved September 2002 for adults. Pediatric clinical trials are being planned.

§ Entecavir (Baraclude) is a pill taken once a day, with almost no side effects for up to one year. It is considered to be the most potent oral antiviral drug for chronic hepatitis B to date. Approved April 2005 for adults. Pediatric clinical trials may be planned for the future.

§ Telbivudine (Tyzeka, Sebivo) is a pill taken once a day, with almost no side effects for up to one year. Studies have shown that it rapidly and profoundly suppresses HBV levels. Approved October 2006 for adults.

Although the FDA has approved these six drugs for chronic hepatitis B, they do not provide a complete cure, except in rare cases (a "cure" generally means that a person loses the hepatitis B virus and develops protective surface antibodies).

The drugs, however, significantly decrease the risk of liver damage from the hepatitis B virus by slowing down or stopping the virus from reproducing. As with HIV, it appears that combination therapy will probably be the most effective method of combating chronic hepatitis B infections.

Who Should Be Treated

The decision of whether to start treatment (or enroll in a clinical trial) should be based on careful evaluation of your physical exam, blood tests, and liver biopsy (if one is done). Be sure you see a liver specialist (hepatologist) for the most current information about hepatitis B therapies.

Studies show that the current treatments appear to be of greatest benefit to those who show signs of active liver disease:

§ Elevated liver enzymes (ALT)

§ Positive blood tests for:
          Hepatitis B virus (HBsAg)
          Hepatitis B e-antigen (HBeAg)

§ Elevated levels of hepatitis B DNA

Some doctors may order a liver biopsy (this involves taking a small sample of your liver to examine under the microscope) to help decide whether treatment is needed, but this practice is not as common as it used to be.

It is always a good idea to get a second opinion before starting any treatment.

Hepatitis B Clinical Trials

The future is bright for people with chronic hepatitis B, thanks in a large part to advancements in medical science. All drugs must go through a testing process, which involves three phases of clinical trials, to evaluate its safety and effectiveness before being approved.

Volunteering for a clinical trial program can be very valuable. Expensive blood work, treatment medications, and doctor’s visits are usually provided free of charge for those accepted into a study. Clinical trials also provide the opportunity to potentially benefit from the latest advances in medical science.

Compounds in Development for Chronic Hepatitis B                                         

Updated July 2007

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
Emtricitabine (FTC)	Inhibits viral DNA polymerase	Gilead Foster City, CA	Phase III
Clevudine (L-FMAU) Levovir (S. Korea)	Inhibits viral DNA polymerase	Pharmasset Princeton, NJ Bukwang South Korea Eiasai, Japan	Phase III, USA Approved S. Korea (Nov. 2006)
Viread (Tenofovir)	Inhibits viral DNA polymerase	Gilead Foster City, CA	Phase III
Valtorcitabine (monoval LdC)	Inhibits viral DNA polymerase	Idenix Cambridge, MA	Phase II
Amdoxovir (DAPD)	Inhibits viral DNA polymerase	RFS Pharm LLC Tucker, GA	Phase II
ANA 380 (LB80380)	Inhibits viral DNA polymerase	Anadys San Diego, CA	Phase II
Pradefovir (Remofovir)	Inhibits viral DNA polymerase	Schering-Plough Madison, NJ	Phase II
RCV (Racivir)	Inhibits viral DNA polymerase	Pharmasset Princeton, NJ	Phase II
Non-Nucleoside Antivirals -  Interfere with proteins involved in viral reproduction
NOV-205 (BAM 205)	Small Molecule	Novelos Newton, MA	Approved in Russia
HepeX-B (XTL-001)	Human monoclonal antibodies	XTL Biopharm and Cubist Pharm, Cambridge, MA	Phase II/III Orphan drug approval in US for liver cancer
Nitazoxanide (Alinia)	Small Molecule	Romark Labs Tampa, FL	Phase II Egypt
UT 231-B *Discovered by HBF Scientists	Small Molecule	United Therapeutics Silver Spring, MD	Preclinical HBV (Phase II HCV)
Bay 41-4109	Inhibits viral nucleocapsid	Bayer AG Germany	Preclinical
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
Hi-8 HBV	Therapeutic HBV Vaccine	Oxxon U.K.	Phase II
HepX (eiRNA)	Expressed Interfering RNA	Nucleonics Horsham, PA	Phase I
HepaVaxx B	Therapeutic HBV Vaccine	Virexx Canada	Phase I
HBV Core Antigen Vaccine	Therapeutic HBV Vaccine	Emergent Europe U.K.	Phase I
SpecifEx-HepB	Immunological Cell Transfer	Chromos Burnaby, BC	Preclinical/ 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