BFAD okays entecavir for treatment of chronic hepa B

Bristol-Myers Squibb has announced that the Bureau of Food and Drugs (BFAD) has approved entecavir for the treatment of chronic hepatitis B virus infection.

The indication is in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Entecavir is an oral antiviral therapy specifically designed to block the replication of hepatitis B virus (HBV) in the liver. The drug will be available in the Philippines in the first quarter of 2006.

Chronic hepatitis B infection is a potentially life-threatening disease. More than half a million people worldwide die each year from primary liver cancer (hepatocellular carcinoma), and up to 80 percent of primary liver cancers are caused by chronic hepatitis B.

In the Philippines, the prevalence rate of chronic hepatitis B ranges from five to 16 percent, placing the country in the intermediate to high endemic region.

More than half (59 percent) of the patients with cirrhosis and 82 percent of patients with liver cancer in the Philippines are caused by hepatitis B infection.

Primary liver cancer is the most common gastrointestinal cancer and third most common cancer in the Philippines.

"With the approval of entecavir in the Philippines, Bristol-Myers Squibb will now be able to address another area of significant unmet medical need: hepatitis B," said David Elsaputra, general manager of Bristol-Myers Squibb Philippines Inc.

"Developed in our own laboratories, entecavir is an important step forward for patients and our company, as we seek to realize our mission of extending and enhancing human life by focusing on discovering, developing and providing innovative treatments for serious diseases," he said.

The Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2005 update states that sustained viral suppression is the key to reduction or prevention of hepatic injury and disease progression and the primary goal of treatment for chronic hepatitis B is to eliminate or permanently suppress the hepatitis B viral load.

Viral load is a key predictor of progression to serious liver disease and hepatocellular carcinoma (HCC or liver cancer). The higher the viral load, the greater the risk of developing cirrhosis and HCC.

With the approval of entecavir, physicians have an important new medication to treat chronic hepatitis B by reducing the viral load and the associated risk of developing cirrhosis and liver cancer.

Discovered at Bristol-Myers Squibb, entecavir is a nucleoside analogue approved for marketing in the United States by the US Food and Drug Administration (FDA) on March 29 last year.

To date, entecavir has also been approved in several countries, including China, Macau and Indonesia.

Bristol-Myers Squibb has submitted marketing applications for entecavir in other regions and countries around the world, including Taiwan, Korea and Hong Kong.

Entecavir is a nucleoside analogue with a recommended dosage of a single 0.5-milligram tablet once daily for chronic hepatitis B patients beginning treatment for the first time (nucleoside-naïve patients), and one-milligram once-daily for patients experiencing resistance to lamivudine (lamivudine-refractory patients).

The entecavir clinical trial program was the largest-ever conducted in chronic hepatitis B, and the first to compare two antivirals, entecavir versus lamivudine.

In these studies after 48 weeks, entecavir demonstrated statistically significant improvements compared to lamivudine in liver histology, HBV viral load reductions to undetectable levels (defined as less than 300 copies/mL) and normalization of alanine aminotransferase (ALT) levels (less than or equal to one times the upper limit of normal), a measure used to determine the degree of liver damage.

In these studies, entecavir demonstrated comparable safety to lamivudine with a favorable resistance profile.

The most common side effects of entecavir in clinical studies were headache, tiredness, dizziness, and nausea. Cross resistance has been observed among HBV nucleoside analogues.

Lamivudine-resistant patients may not respond as well as nucleoside-naïve patients to entecavir therapy.

For more information on hepatitis B and its treatment, patients are advised to consult their physicians.

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.