New Drug :Tyzeka (Telbivudine) for Chronic Hepatitis B (HBV)) , Approved by FDA

New Drug :Tyzeka (Telbivudine) for Chronic Hepatitis B (Hbv) , Approved by Fda

Although there are several different types of hepatitis, hepatitis B is a type that can move from one person to another through blood and other bodily fluids. It can be transmitted through sexual intercourse and through needles — such as those shared by intravenous drug or steroid users who have the virus, or tattoo needles that haven't been properly sterilized. A pregnant woman can also pass hepatitis B to her unborn baby. You cannot catch hepatitis B from an object, such as a toilet seat.


Because hepatitis B can easily be transmitted through blood and most body fluids, it can be prevented by:

Recently,the Food and Drug Administration (FDA) approved Tyzeka (telbivudine) for the treatment of adults with chronic hepatitis B (HBV), a serious viral infection that attacks the liver and can cause lifelong infection, scarring of the liver (cirrhosis), and eventually liver cancer, liver failure, and death. Tyzeka is a new molecular entity, which is a term used by the FDA to describe a medication containing an active substance that has never before been approved for marketing in any form in the United States.

"In a typical year, an estimated 70,000 Americans become infected with chronic HBV, and some 5,000 of them will die of the complications caused by the disease," said Dr. Steven Galson, Director of the Center for Drug Evaluation and Research. "Tyzeka offers prescribers another option for treating these patients."

Tyzeka was studied in a year-long international clinical trial in 1,367 patients with chronic HBV. Three-quarters of the trial participants were male, and all were 16 years of age or older. The trial produced evidence of antiviral effectiveness, including the suppression of hepatitis B virus, and improvement in liver inflammation comparable to Epivir-HBV (lamivudine), one of five other medications approved to treat patients with chronic HBV.

HBV is spread when blood from an infected person enters the body of a person who is not infected, sometimes by sexual contact or blood contamination. Tyzeka is not a cure for hepatitis B, and long-term treatment benefits of this drug are not known. Use of Tyzeka has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

In clinical studies Tyzeka was generally well tolerated, and most reported adverse events were mild to moderate. The most common side effects were elevated CPK (creatinine phosphokinase, an enzyme that is present in muscle tissue and is a marker for breakdown of muscle tissue), upper respiratory tract infection, fatigue, headache, abdominal pain and cough.

Also, after several weeks to months of Tyzeka use, some patients developed symptoms ranging from transient muscle pain to muscle weakness. Those who developed muscle weakness experienced significant improvement in their symptoms when Tyzeka was discontinued.

Patients should only stop Tyzeka after a careful discussion with their doctor. As has happened with other forms of treatment for hepatitis B, some patients who discontinued Tyzeka experienced a sudden and severe worsening of their hepatitis B. Therefore, patients who discontinue Tyzeka should be closely monitored by their doctor for at least several months.

Among drugs in the same class as Tyzeka, some cases of lactic acidosis (too much acid in the body due to buildup of lactic acid) and severe enlargement and accumulation of fat in the liver, including fatal cases, have been reported.

Tyzeka is manufactured by Novartis Pharma Stein AG, Stein, Switzerland and marketed and distributed by Idenix Pharmaceuticals, Inc., Cambridge, MA.

Comments

Post new comment

Similar

New Bird Flu Virus Strain Has Become Dominant

Image of New Bird Flu Virus Strain Has Become Dominant H5N1 flu refers to the transmission and infection of H5N1. H5N1 flu is a concern due to the global spread of H5N1 that constitutes a pandemic threat.Infected birds pass on H5N1 through their saliva,

Blood sugar monitoring is useful in predicting blood sugar levels

Image of Blood sugar monitoring is useful in predicting blood sugar levels Blood glucose monitoring is a measurement of glucose in the blood that can be done at any time on a portable machine. It can be a self-test for the diabetic. The finger is pricked and a drop of blood

Drugs that Reduce Stomach Acid Do Not Accelerate The Risk of Esophagus or Stomach Cancer

Drugs that Reduce Stomach Acid Do Not Accelerate The Risk of Esophagus or Stomac In the digestive system, an ulcer is an area where tissue has been destroyed by gastric juices and stomach acid. Peptic ulcer disease is a general term for ulcers that occur in the stomach or

How Can You Avoid Problems With Your Diabetic Feet?

How can You Avoid Problems With Your Diabetic Feet? Diabetes causes your blood sugar levels to be higher than normal. Over time, high blood sugar levels can damage the blood vessels and nerves in your body.People with diabetes often have trouble with

Antibiotic Rifaximin (Xifaxan) Might Be Treatment Of Irritable Bowel Syndrome (IBS)

Antibiotic Rifaximin (Xifaxan) Might Be Treatment Of Irritable Bowel Syndrome Irritable bowel syndrome is characterized by a combination of abdominal pain and altered bowel function. There are many possible causes. For instance, there may be a disturbance in the muscle

Withdrawal Time During Colonoscopy Test Should be More Than Six Minutes

Withdrawal Time During Colonoscopy Test Should be More Than Six Minutes for Earl Colonoscopy is almost always painless and most patients are asleep for the entire procedure. Taking laxatives and/or enemas before the test to clean out the colon isn't fun, but most people find this

New Nt-Probnp Blood Test will be Helpful to Determine The Risk for Developing of Future Heart Attack, Stroke or Death

New Nt-Probnp Blood Test will be Helpful to Determine The Risk for Developing of For both men and women, the biggest factors that contribute to heart disease are smoking, high blood pressure, high cholesterol, family history and age. Take a moment to look at your lifestyle,