Liver Health Current Topics in Liver Health

New Drug for Hepatitis B Approved by the FDA

(HealthCentersOnline) - After a year-long international study, the Food and Drug Administration (FDA) has approved a new drug for the treatment of chronic hepatitis B in adults.

The drug, telbivudine (Tyzeka), is categorized by the FDA as a new molecular entity—a medication that contains an active substance that has never been approved by the FDA for marketing in the United States.

Hepatitis B (HBV) is caused by contact with bodily fluids of a person infected with the hepatitis B virus. It can be transmitted through sexual intercourse or blood contamination, such as with intravenous drug use.

HBV is a serious viral disease that attacks the liver. It can cause lifelong infection, cirrhosis, liver cancer, liver failure and eventual death. There are an estimated 1.25 million Americans living with chronic hepatitis B.

The drug trial included nearly 1,400 patients with chronic HBV, aged 16 years and older. The patients were followed for a year and evaluated for treatment response. Results revealed evidence of antiviral effectiveness, including suppression of the hepatitis B virus.

In addition, patients who used Tyzeka showed an improvement in liver inflammation comparable to another medication approved by the FDA for treatment of chronic HBV.

Tyzeka is not a cure for hepatitis B and the long-term effects of the drug are unknown. In addition, the drug has not been shown to decrease the risk of transmission of HBV to others through blood contamination or sexual contact.

Most patients tolerated the drug with only mild to moderate side effects. The most common included elevated creatinine phosphokinase (CPK), an enzyme linked to the breakdown of muscle tissue. Other reported adverse reactions were upper respiratory infection, fatigue, headache and abdominal pain.

Some patients developed muscle pain or weakness after using Tyzeka for several weeks to months. Those with muscle weakness experienced significant improvement in their symptoms once they stopped taking Tyzeka.

Chronic HBV patients should not discontinue Tyzeka without consulting their physician. Patients who stopped taking Tyzeka developed a sudden and severe worsening of their disease. This response has also been noted with the discontinuation of other forms of HBV treatments.

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