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Newer hepatitis drug more effective: studies

Posted on: Thursday, 9 March 2006, 08:13 CST

By Gene Emery

BOSTON (Reuters) - Entecavir, a new drug designed to battle frequently fatal hepatitis B, is more effective than a rival drug, according to a pair of research studies financed by the drug's manufacturer Bristol-Myers Squibb Co.

The two studies on long-term liver disease were published in this week's New England Journal of Medicine and found that entecavir does a better job than GlaxoSmithKline's drug, Epivir.

"Entecavir seems to be an outstanding agent for treating chronic hepatitis B," because of its effectiveness and the low rate at which the hepatitis B virus becomes resistant to the drug, Jay Hoofnagle of the National Institute of Diabetes and Digestive and Kidney Diseases wrote in a Journal editorial.

The two drugs are among five approved in the United States to treat the often deadly illness, which can destroy the liver and lead to liver cancer. A vaccine that prevents hepatitis B is also available, and is routinely given to newborns in Taiwan and China, where the illness is common.

About 1.5 million Americans carry hepatitis B, which is spread by contaminated needles or sexual contact.

In a new study on the form of chronic hepatitis known as HBeAg-positive, a team led by Ting-Tsung Chang of the National Cheng Kung University Medical College in Taiwan found that 72 percent of the 314 patients treated with entecavir showed improvement after 48 weeks of treatment. Among the patients who were treated with Epivir, known generically as lamivudine, only 62 percent of the 314 patients improved in the same time.

Hepatitis B virus particles dropped to undetectable levels in 67 percent of the people in the entecavir group, compared with 36 percent of the lamivudine recipients.

A second study of 583 HBeAg-negative patients, conducted by many of the same researchers, showed similar results.

In the United States, a month's supply of 0.5 milligram tablets of entecavir, sold under the brand name Baraclude, costs about $650, four times the cost of lamivudine.

Hoofnagle warned that although the drugs work well, treatment can still be complicated because "it is still unclear who should be treated, with which agent (or combination of agents), for how long," and the best way to monitor patients.

In addition, the virus can develop a resistance to one of the drugs. For example, after four years of taking lamivudine, 70 to 80 percent of patients become resistant to it.

"Perhaps the most promising aspect of entecavir therapy has been the low rate of antiviral resistance," Hoofnagle said.

And if people stop taking anti-hepatitis drugs, the disease tends to return with renewed vigor, which can lead to death.

"Once treatment with oral antiviral agents has begun, it is difficult to stop," he said.

Source: REUTERS

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