BETHESDA — BETHESDA -- Signaling a new era in AIDS treatment, an expert panel recommended yesterday that doctors act early and aggressively in attacking the disease with new drug combinations.
The recommendations land squarely on the conclusion that protease inhibitors in combination with other anti-viral drugs should be given to everyone who has the disease and to many others who are infected but have not developed symptoms.
"The guts or the meat of these guidelines is to treat aggressively, to get the virus down as low as possible, for as long as possible," said Dr. Anthony S. Fauci, director of the National Institutes of Allergy and Infectious Disease.
Doctors should erase any notion that the drugs can be phased in gradually to minimize side effects or to get a taste of the medications' effectiveness, the panel said in a report that was released for public comment yesterday before being made final.
Such an approach could be a recipe for failure, allowing the virus to "break through" and defeat further efforts at treatment.
"A little bit of treatment is not something we can advocate," said Dr. John Bartlett, chief of infectious diseases at the Johns Hopkins School of Medicine.
"Once the virus escapes, then you've lost the drugs that you've given."
The Panel on Clinical Practices for HIV Treatment was convened in December 1996 by the U.S. government and the Henry J. Kaiser Family Foundation to help resolve questions -- and confusion -- raised by the new drugs used in the fight against AIDS. Fauci and Bartlett are its chairmen.
Almost overnight, the medications brought optimism to a field that had only known rising death tolls. But the drugs also made the treatment of AIDS patients more complicated than ever.
Some doctors argued that the drugs ought to be introduced late in an illness. They feared that the drugs, if started early, might lose their effectiveness before the patient needed them most.
But the panel recommended the opposite: using the drugs to knock "viral load" (the amount of virus particles in a patient's bloodstream) to extremely low levels before the human immunodeficiency virus (HIV) has a chance to decimate the immune system.
Among the recommendations:
Triple-drug combinations should be given to everybody suffering symptoms of acquired immune deficiency syndrome. The regimen should include a protease inhibitor and two other medications from an older category (nucleoside reverse transcriptase inhibitors) that includes AZT.
The combinations should also be given to many people who are infected with the AIDS virus but have yet to develop symptoms. These are people whose immune systems have declined below a threshold (CD4 cell counts of less than 500) or whose viral loads have exceeded 20,000 copies.
Two-drug combinations are considered "suboptimal;" single-drug therapy should be given in one case only. Pregnant women who do not need anti-viral therapy for their own health can take AZT alone to reduce the risk of passing the virus to their babies.
Once therapy is started, it should be used indefinitely.
Fauci said that the guidelines are flexible and leave room for doctors to make certain changes, such as beginning therapy even earlier for asymptomatic patients.
In such cases, patients should consider whether they want to commit themselves to the drugs at a stage when they might otherwise remain in good health for months, even years.
"It is not a trivial matter to put people on multiple combinations of drugs," Fauci said. "It can change one's lifestyle. It can sometimes make one ill."
There is also the possibility that the virus will develop resistance to the drugs, making it more difficult to treat the patient later.
Bartlett estimated that about 180,000 people in the United States are on three-drug regimens that include protease inhibitors. This represents about 60 percent of the 300,000 people now in care.
"About 80 percent of the patients achieve the goal of no detectable virus for a period of one or two years," Bartlett said. The drugs have not been available long enough for doctors to learn about their longer-term benefits.
Only about half of the people who are infected with the AIDS virus are now in care, he said. And many who are seeing doctors are having trouble getting insurance coverage for the drugs, which can cost $10,000 to $12,000 a year.
Besides giving doctors a blueprint for treatment, panel members said they hoped the guidelines would make it difficult for insurers to skimp on the drugs or delay their use.
Pub Date: 6/20/97