Hepatitis B is a contagious liver disease caused by the hepatitis B virus (HBV), one of three viral agents that cause inflammation of the liver known as hepatitis or diffuse hepatocellular inflammatory disease. Hepatitis B is characterized by fever, nausea, vomiting, and yellow discoloration of the skin, eyes and mucous membranes (jaundice). In its most serious form, if left untreated, hepatitis B can become a chronic infection leading to chronic liver disease and potentially increasing the risk of developing liver cancer. The hepatitis B virus can be passed from mother to unborn child, and is highly contagious through bodily fluids such as blood, semen and possibly saliva. It is often spread from person to person through intravenous drug use or sexual contact.
Hepatitis B virus usually has a one to six week incubation period during which a certain antigen (immune response agent) circulates in the blood before symptoms of the illness develop. Hepatitis B may initially appear as influenza symptoms (fever, headache, eye-ear-nose-throat involvement, chills, tiredness, itchy rash, etc.), followed by nausea, vomiting and yellow discoloration of skin, eyes, and mucous membranes (jaundice). Affected individuals may also experience loss of appetite and abnormal tenderness of the upper right portion of the stomach. Because similar symptoms also occur with other diseases such as mononucleosis or chronic liver disease, hepatitis B may be difficult to diagnose.
In some cases, hepatitis B may eventually lead to damage and scarring of the liver (cirrhosis). Some affected individuals may develop chronic liver disease. In most cases, hepatitis B usually runs its course in four to eight weeks, except in some variations of the disease. For information on these, please see the Related Disorders section of this report.
Hepatitis B is a form of acute viral hepatitis. It is caused by infection with the hepatitis B virus. It is usually transmitted by injection (parenterally). Transfusion of contaminated blood or blood products to hospitalized patients is a typical source of the disorder. Sharing contaminated hypodermic needles by drug abusers often spreads the disease. An increased risk to patients and personnel working in renal dialysis units has also been identified.
The infection can also be spread through sexual activity. The infection can be passed from a mother to a baby during pregnancy or through breastfeeding. In rare cases, sharing a toothbrush or razor with an affected individual may lead to the development of hepatitis B.
In many cases the source of infection with hepatitis B virus is unknown.
Hepatitis B virus is the second-leading sexually transmitted disease in the United States. More than one million Americans are chronic carriers of the virus. More than 300,000 new cases of hepatitis B infection occur in the United States each year. While sixty-five percent of the cases of hepatitis B are reported in the twenty to thirty-nine year age group, the male-to- female ratio remains 2:1. Hepatitis B affects approximately 350 million individuals worldwide.
High rates of hepatitis B have been found in South East Asia, sub-Saharan, Africa and parts of South America. The World Health Organization (WHO) estimates that over two billion individuals worldwide have been affected by acute hepatitis B. It is further estimated that 350 million of those individuals are chronic carriers of the virus. It is believed that over one million children are born with hepatitis B. Approximately four million cases of acute hepatitis B are recorded to the WHO every year.
Individuals affected by hepatitis B may not show symptoms until six weeks to six months after exposure to the virus. A diagnosis may be suspected, based upon a thorough clinical evaluation, a detailed patient history, and identification of characteristic symptoms. A diagnosis may be confirmed through blood tests.
The best treatment of hepatitis B infection is prevention.
The Food and Drug Administration (FDA) has approved the anti-viral drug adefovir dipivoxil (Hepsera) for the treatment of Hepatitis B. This pharmaceutical is manufactured by:
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The first genetically engineered hepatitis vaccine was approved by the FDA during the mid-1980s. The new vaccine, called Recombivax HB (like the less effective plasma-derived vaccine developed in 1981), is produced by Merck, Sharp & Dohme, West Point, PA.
The FDA urges that the new vaccine be used by individuals who are at high risk of becoming infected with hepatitis B, including dental and medical workers, homosexuals, drug users, and personnel who work with mentally disabled individuals in institutional or day care settings.
Because the vaccine can be given to newborns, passage of hepatitis from infected mothers to their offspring can be prevented. Pregnant women from high-risk groups can be tested to determine if they are carriers. Then their infants can be protected by early vaccination. Three injections are recommended for high-risk individuals, including infants of infected mothers.
The FDA has also approved the antiviral agent lamivudine (Epivir-HBV) for the treatment of adults with infection with the hepatitis B virus. Lamivudine appears to be an inhibitor of the hepatitis B virus (HBV). During clinical trials, the drug was well tolerated by affected individuals. However, research suggested that, in some cases, treatment of individuals with hepatitis B with lamivudine led to the hepatitis B virus developing a resistance to the drug. Researchers suggested using lamivudine in conjunction with other drugs, such as famciclovir. However, clinical trials investigating the safety and effectiveness of these drugs for hepatitis B are still ongoing. The drug is manufactured by GlaxoWellcome.
An appropriate formulation of the new vaccine for kidney patients on dialysis is not yet available.
In March of 2005, the FDA approved the use of entecavir (Baraclude) for the treatment of chronic hepatitis B in adults. Entecavir slows the progression of the disorder by interfering with viral reproduction. For more information on this drug, contact:
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Other treatment of hepatitis B is symptomatic and supportive. There are no effective antibiotics to treat hepatitis, but Schering-Plough's Intron A (Interferon-alpha 2a-2b) has been shown to be a safe and effective treatment for hepatitis B and C (Non-A, Non-B). In general, extended rest and a light diet seem to be of benefit. Avoiding alcohol is also recommended for individuals with hepatitis B.
Information on current clinical trials is posted on the Internet at www.clinicaltrials.gov. All studies receiving U.S. government funding, and some supported by private industry, are posted on this government web site.
For information about clinical trials being conducted at the NIH Clinical Center in Bethesda, MD, contact the NIH Patient Recruitment Office:
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For information about clinical trials sponsored by private sources, contact:
Scientists are studying all forms of hepatitis to learn how it can better be prevented, diagnosed, and treated. A new drug, thymosin alpha-1 or thymalfasin (Zadaxin), is being developed by SciClone Pharmaceuticals, Inc. for the treatment of chronic active hepatitis B. Initial studies have demonstrated that the drug produces a sustained response in individuals with the immune tolerant phase of the disease. The drug is currently in phase III clinical trials in the United States.
Sandoz Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ, 07936, has developed a new biologic to help prevent hepatitis B reinfection of individuals who are receiving liver transplants as a result of end-stage liver damage from chronic hepatitis B infection. The biologic is human monoclonal antibody against hepatitis B virus.
The National Institutes of Health is conducting a study to determine the effect of the use of interferon and famiclovir in combination as a treatment for hepatitis B. They are also conducting a study to determine the effect of lamivudine for the treatment of hepatitis B. More studies are needed to determine the long-term safety and effectiveness of these treatments. Individuals who are interested in participating in this study should contact:
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Researchers are studying the anti-viral drug tenofovir (Viread) for the treatment of hepatitis B. Initial studies show that tenofovir is effective in treating individuals with hepatitis B. One current study seeks to determine the effectiveness of tenofovir versus adefovir for the treatment of HBeAg negative chronic hepatitis B. More research is necessary to determine the long-term safety and effectiveness of this drug for individuals with hepatitis B. For more information, contact:
333 Lakeside Drive
Foster City, CA 94404
Phone: (650) 574-3000
Fax: (650) 578-9264
Toll Free: 1-800-GILEAD-5
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