FDA Panel Backs Hepatitis B Pills

The Associated Press

WASHINGTON (AP) — Government advisers recommended approval Tuesday of the first oral therapy for liver-destroying Hepatitis B — a drug now used to fight AIDS.

Advisers to the Food and Drug Administration voted unanimously that Epivir, better known as 3TC, can help protect patients’ livers from the Hepatitis B virus.

But hepatitis patients need to take lower doses of Epivir than patients who have the HIV virus that causes AIDS. If the FDA approves the drug’s new use, Glaxo Wellcome Inc. would sell the appropriate dose under the brand name Epivir HBV.

The FDA is not bound by advisory committee recommendations, but usually follows them.

But the advisory committee cautioned that no one yet knows how long hepatitis patients should take the drug, which was studied for just a year, or whether it helps patients with advanced hepatitis.

Epivir cannot cure Hepatitis B, a virus that infects an estimated 1 million Americans. But it appears to target an enzyme important for the virus’s reproduction, lowering the amount of hepatitis in patients’ blood and improving the liver’s health.

The only current FDA-approved treatment for Hepatitis B is injected interferon.

In one study of Americans with mild to moderate infection, 55 percent who took Epivir showed improvement when doctors took liver biopsies, vs. 25 percent of patients who took a dummy pill.

Doctors would have to test hepatitis patients for HIV before prescribing the drug, because patients with double infections would need the higher HIV dose, said FDA’s Dr. Heidi Jolson. Also, no one is sure whether stopping Epivir could cause a dangerous hepatitis flare-up, she said.

AP-NY-10-06-98 1746EDT

Copyright 1998 The Associated Press.