SILVER SPRING, Md. — The drug 3TC should be approved as the first new initial therapy to treat AIDS since 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 HIV in their blood. But more significantly, the drug combination showed more effect in patients who had never taken AZT than in those who had 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 questions that patients must be aware of before choosing the combination therapy over AZT alone. All other AIDS drugs sold today are for use after AZT fails.
The advisory panel today will consider a long-anticipated new generation of AIDS drugs called protease inhibitors. FDA Commissioner David A. Kessler has said these drugs promise the most powerful medicine yet to stall, but not cure, the AIDS virus.
The FDA is not obliged to accept the recommendations of advisory panels, but it usually does.