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 7 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 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 and depression. Approved May 2005 and available only for adults.
Adefovir Dipivoxil (Hepsera) is a pill taken once a day, with few side effects, for at least one year or longer. Approved September 2002 for adults. Pediatric clinical trials are in progress.
Entecavir (Baraclude) is a pill taken once a day, with few side effects, for at least one year or longer. Approved April 2005 for adults. Pediatric clinical trials are in progress.
Telbivudine (Tyzeka, Sebivo) is a pill taken once a day, with few side effects, for at least one year or longer. Approved October 2006 for adults.
Tenofovir (Viread) is a pill taken once a day, with few side effects, for at least one year or longer. Approved August 2008 for adults.
Although the FDA has approved these seven 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.
Comparison of Costs of HBV Antiviral Therapy
(Based on average 2005 wholesale prices in the U.S.)
|Drug Name||Monthly Cost||Annual Cost||FDA Status|
|Lamivudine 150 mg||$204||$2,482||Approved|
|Adefovir (10 mg)||$546||$6,647||Approved|
|Entecavir (0.5 mg)||$715||$8,694||Approved|
|*Peginterferon alfa-2a (180 mcg)||$1,540||$18,480||Approved|
|Emtricitabine (200 mg)||$318||$3,872||Phase III|
|Tenofovir (300 mg)||$478||$5,811||Phase III|
*Although peginterferon alfa-2a has the highest monthly and annual cost, it would likely be given for only one year at most, whereas the oral agents would be given continuously for many years, or perhaps a lifetime.