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Baraclude Beats Epivir for Hepatitis B

So Far, Newest Hepatitis B Drug Looks Great -- but Still No Cure
By
WebMD Health News
Reviewed by Louise Chang, MD

March 8, 2006 -- In a head-to-head battle of hepatitis B drugs, the new drug Baraclude beats the older Epivir.

Two international studies pitting Baraclude against Epivir appear in the March 9 issue of The New England Journal of Medicine.

By every measure, each of the two studies showed Baraclude superior to Epivir. One study looked at patients who did not have the so-called "e" antigen of hepatitis B virus. The other looked only at patients who did have e antigen. Hepatitis B e antigen is a sign that a patient is highly infectious -- and a sign of worse infection.

In patients negative for hepatitis B e antigen, after 48 weeks of treatment:

  • 90% of those taking Baraclude and 72% of those taking Epivir no longer had detectable virus in their blood.
  • 70% of those taking Baraclude and 61% of those taking Epivir had improved liver biopsies.

In patients positive for hepatitis B e antigen, after 48 weeks of treatment:

  • 67% of those taking Baraclude and 36% of those taking Epivir no longer had detectable virus in their blood.
  • 72% of those taking Baraclude and 62% of those taking Epivir had improved liver biopsies.

Not included in the contest is a third antiviral drug, Hepsera. It, too, has advantages over Epivir.

Disadvantages

The bad news: There's still no cure for hepatitis B infection. There's a vaccine to prevent hepatitis, but once you've been infected, there's still no way to get rid of it. Epivir, Hepsera, and Baraclude do prevent progression of hepatitis B disease. But there's a catch.

Some 70% to 80% of patients treated with Epivir develop drug-resistant virus after four years. The same thing happens to 15% to 20% of patients after four years of Hepsera treatment. And once the virus becomes resistant to the drugs, it comes back worse than ever. The same thing happens when patients stop taking the drugs.

There is good news in terms of the new Baraclude-vs.-Epivir study. Patients taking Baraclude for one year show no signs of drug-resistant virus. Since treatment must continue indefinitely, there's still plenty of time for resistance to appear. But the new drug seems superior in this regard.

Even so, an editorial accompanying the two studies carries a warning. It comes from Jay H. Hoofnagle, MD, director of the liver disease research branch of the National Institute for Diabetes, Digestive, and Kidney Diseases.

"With its excellent potency and low rate of resistance, [Baraclude] seems to be an outstanding agent for treating chronic hepatitis B," Hoofnagle writes. "Its use at present, however, should be tempered with the knowledge that this chronic liver disease is likely to require long-term therapy."

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