Taiwan: Newer Hepatitis Drug More Effective -- Study

Two studies published today indicate that Bristol-Myers Squibb's new drug Baraclude (entecavir) is more effective against hepatitis B than GlaxoSmithKline's Epivir (lamivudine). The two drugs are among five approved for hepatitis B treatment in the United States.

In an editorial accompanying the studies, Jay Hoofnagle of the National Institute of Diabetes and Digestive and Kidney Diseases wrote, "Entecavir seems to be an outstanding agent for treating chronic hepatitis B," due to its effectiveness and the low rate at which the virus develops resistance to it.

The new study focused on HBeAg-positive chronic patients. The researchers, led by Ting-Tsung Chang of the National Cheng Kung University Medical College in Taiwan, reported that 72 percent of 314 patients treated with entecavir experienced improvement after 48 weeks of treatment. Only 62 percent of 314 lamivudine-treated patients showed improvement in the same time period. In the entecavir group, 67 percent of patients achieved an undetectable level of hepatitis B virus particles; 36 percent of the lamivudine patients achieved undetectable levels.

The same researchers conducted a study of 583 HBeAG-negative chronic hepatitis B patients, with similar results.

"Perhaps the most promising aspect of entecavir therapy has been the low rate of antiviral resistance," Hoofnagle wrote in his editorial. After four years of lamivudine therapy, 70-80 percent of patients develop resistance to the drug. However, Hoofnagle warned that 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 how best to monitor patients. In addition, he wrote, "Once treatment with oral antiviral agents has begun, it is difficult to stop," since the virus tends to rebound when therapy is halted.

Bristol-Myers Squibb, entecavir's maker, funded the study. In the United States, a month's supply of 0.5 milligram entecavir tablets costs about $650, which is four times the cost of lamivudine.

The studies, "A Comparison of Entecavir and Lamivudine for HBeAg-Positive Chronic Hepatitis B" and "Entecavir Versus Lamivudine for Patients with HBeAg-Negative Chronic Hepatitis B," and the editorial, "Hepatitis B, Preventable and Now Treatable," were published in the New England Journal of Medicine (2006;354(10):1001-1010, 1011-1020, 1074-1076, respectively).

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