Hepatitis B Treatment

Hepatitis B is the most common serious liver infection in the world, and according to the World Health Organization (WHO), it is 100 times more infectious than HIV.14 The virus is transmitted through direct contact with blood and bodily fluids that contain blood. The hepatitis B virus (HBV) targets the liver and eventually causes scarring of the liver (also known as cirrhosis), liver failure or cancer of the liver, and even death. Most adults who become infected with hepatitis B clear the virus and recover from the infection. However, some people develop a chronic condition that requires treatment to prevent further damage to the liver.

In the US, the Centers for Disease Control and Prevention estimate that more than one million Americans are already chronically infected with hepatitis B.9 In addition, approximately 100,000 new people will become infected this year alone. The health risks are high as there is no known cure although there are treatments that can help those living with chronic HBV, and there are promising new drugs in the pipeline. But even with the current available treatments, each year it is estimated that 5,000 Americans die from hepatitis B and its complications.

The Path of the Hepatitis B Virus

Knowing a bit about viruses and how they grow inside the body will help highlight the challenges of treating chronic hepatitis B. Chronic hepatitis B is caused by persistent replication of the hepatitis B virus (HBV). Unlike bacteria, for which there are antibiotics that kill the "germs," there is no cure for infection with the hepatitis B virus. In part, this is because hepatitis B viruses are particles that are fragments of DNA which have a protective coat. And since DNA is part of our cellular structure, the virus becomes a part of us. In the case of hepatitis B, the DNA is known as HBV DNA.

The hepatitis B virus is very specific and only attacks host cells that are in the liver. Once it binds to the liver host cell, HBV DNA enters the host cell's nucleus, where a rather complex replication process takes place. When the process is completed, new hepatitis B virus leaves the host cell and is ready to bind to a new host cell, and the cycle starts all over again.

Interestingly, HBV does not directly damage liver cells. Instead, it is actually your immune system's response to the viral infection that causes the damage. Whenever the body is attacked by a foreign object, whether it is a splinter or a bacteria or a virus, the immune system responds in many ways, including increasing blood flow, increasing the number of white blood cells, and increasing the number of T-cells. In the case with HBV, the virus binds to the surface of the host cell of the liver. The immune system targets the virus by producing T-cells that attack and destroy the liver cell. Chronic hepatitis B is caused by a constant assault by the immune system on liver cells that have been chronically infected by the virus. This unrelenting assault on the liver can cause cirrhosis, which can progress to liver failure or liver cancer, and ultimately death.

The Spread of Hepatitis B Can Be Prevented

Vaccinations are the first line of defense in preventing hepatitis B. In 2002, the American Academy of Pediatrics, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, and the American Academy of Family Physicians recommended that all newborns receive the first dose of the hepatitis B vaccination before leaving the hospital and that all children and adolescents up to the age of 18 receive the HBV vaccine. The vaccine is also recommended for all adults who may be at high risk for infection.

Asians and Asian-Americans Are at Greater Risk for Contracting Hepatitis B

Among the 1.25 million Americans who are chronically infected with hepatitis B, nearly half are of Asian or Pacific Island descent. While only 1 in 20 individuals in the general U.S. population is infected with hepatitis B, among Asian Americans the incidence is 1 in 10.8 Of even greater concern is the fact that one out of four hepatitis B carriers will die of chronic liver failure or liver cancer. The incidence of liver cancer in men is 7 to 13 times higher among Asian and Pacific Islander Americans (API) than in white Americans and is the fourth leading cause of cancer for Chinese Americans.7

EPIVIR-HBV — First-Line Therapy in the Treatment of Adults and Children With Chronic Hepatitis B

EPIVIR-HBV (lamivudine) was introduced by GlaxoSmithKline in 1998 and was the first FDA-approved oral antiviral for the treatment of chronic hepatitis B (CHB). For patients, this was an important alternative. Unlike other therapies which required weekly injections, EPIVIR-HBV, a 100-mg tablet, could be taken orally once a day. In August 2000 EPIVIR-HBV became the only oral FDA-approved treatment for chronic hepatitis B in children between the ages of 2 and 17. Today, EPIVIR-HBV is still the only oral treatment available for children.

EPIVIR-HBV significantly reduces viral load in adults11
EPIVIR-HBV normalizes ALT levels11
EPIVIR-HBV significantly reduces liver inflammation and necrosis11
EPIVIR-HBV increases HBeAg seroconversion11 ,15 ,16
EPIVIR-HBV is the only oral agent approved for use in children as young as 2 years of age with CHB17
EPIVIR-HBV significantly improves complete virologic response in children 2 to 17 years with compensated CHB11,17
EPIVIR-HBV normalizes ALT levels in children 2 to 17 years with compensated CHB11,17
EPIVIR-HBV is dosed once a day
EPIVIR-HBV is the only treatment for hepatitis B available in an oral solution

How Does EPIVIR-HBV Work?

EPIVIR-HBV suppresses HBV replication by preventing viral DNA synthesis. EPIVIR-HBV is recognized by the viral polymerase and is incorporated irreversibly into the growing viral DNA strand preventing further replication. Once the chain is broken, the virus stops reproducing itself.

EPIVIR-HBV does not cure chronic hepatitis B and it does not reduce the risk of spreading hepatitis B to others.

Important Safety Information About EPIVIR-HBV

EPIVIR-HBV is indicated for the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other retrovirals.

Human immunodeficiency virus (HIV) counseling and testing should be offered to all patients before beginning EPIVIR-HBV and periodically during treatment, because EPIVIR-HBV tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as EPIVIR^® Tablets and Oral Solution used to treat HIV infection. If treatment with EPIVIR-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of subtherapeutic dose and inappropriate monotherapy.

Patients should be assessed before beginning treatment with EPIVIR-HBV by a physician experienced in the treatment of chronic hepatitis B.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

The relationship between treatment response and long-term outcomes, such as hepatocellular carcinoma or decompensated cirrhosis, is not known. Safety and effectiveness of treatment beyond 1 year have not been established, and the optimal duration of treatment is not known.

EPIVIR-HBV does not cure chronic hepatitis B and it does not reduce the risk of spreading hepatitis B to others.

Pancreatitis has been reported, particularly in HIV-infected pediatric patients with prior nucleoside exposure.

In controlled clinical trials, the most common adverse events with EPIVIR-HBV (and placebo) were ear, nose, and throat infections 25% (21%); malaise and fatigue 24% (28%); and headache 21% (21%).

If you have tested positive for chronic hepatitis B, talk to your doctor to see if EPIVIR-HBV may be appropriate for you.

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