
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: TUESDAY, November 7, 1995                   TAG: 9511070069
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-3   EDITION: METRO 
SOURCE: Associated Press
DATELINE: SILVER SPRING, MD.                                LENGTH: Medium

PANEL URGES FDA TO APPROVE 3TC, NEW AIDS DRUG

The drug 3TC should be approved as the first new initial therapy to treat AIDS since the original AIDS drug AZT, scientific advisers told the Food and Drug Administration on Monday.

A combination of 3TC and AZT boosted the immune system of patients and lowered the amount of the HIV virus, which causes AIDS, in their blood.

But more significantly, the drug combination showed more effect in patients who had never taken AZT than in those who have taken AZT alone, as is standard for most patients, manufacturer Glaxo Wellcome said.

The FDA advisers agreed, although they cautioned there are a lot of unanswered questioned that patients must be aware of before choosing to try the combination therapy over AZT alone.

``I am very uncomfortable giving this regimen in a widespread way'' because of all the questions, said Dr. Douglas Mayers of Walter Reed Army Institute of Research in Washington.

Early data ``support the argument for initial aggressive therapy,'' said Glaxo research chief Marc Rubin. ``3TC-AZT was consistently associated with greater and more sustained response.''

The experimental drug is in the same family as AZT, the standard therapy. These drugs work by blocking a protein vital in the early reproduction phase of HIV.

But patients develop resistance to AZT's effect rapidly. Early data indicate that adding 3TC to AZT postpones that resistance - and in some patients might even restore their AZT sensitivity, Glaxo said.

Tests of several hundred patients show the combination boosts the level of vital immune cells called CD4. It also reduces the amount of HIV in the blood by 85 percent to 92 percent, a drop that lasts at least six months, Glaxo said.

The panel agreed that this early data was sufficient to approve 3TC for moderate to advanced AIDS patients as well as offering it as an initial therapy.

The advisers also recommended that the FDA allow Glaxo to sell strawberry-banana-flavored drops of the drug for children, although there was little if any evidence that the children experienced a benefit like that seen in adults.

Despite the lack of evidence, doctors argued that children shouldn't be denied the potential that the therapy works.

`We have to realize the options for kids are quite limited,'' said Dr. Scott Hammer of New England Deaconess Hospital in Boston.

by CNB