Recommendations call for later initiation of anti-HIV drugs

AP 31 January 2001

Washington — New guidelines for the use of antiretroviral AIDS drugs call for starting the therapy later in the course of the disease for patients who show no symptoms. The guidelines, still being fine-tuned, recommend waiting until patients have higher levels of virus in their blood and lower levels of white blood cells before starting treatment with a powerful combination of drugs.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday the change is being recommended because it is now recognized that HIV-infected patients may have to take anti-HIV drugs permanently. The revised guidelines are being developed by a committee that is a joint effort of the Department of Health and Human Services and the Henry J. Kaiser Family Foundation. The guidelines are the distilled recommendations of HIV experts, intended to help doctors and HIV patients make treatment decisions.

When the guidelines were first drawn up, it was hoped that the HIV antiretroviral therapy would be only temporary, and the drugs eventually would eradicate the virus in the patients. There was little worry that patients might develop toxicity reactions to the drug, because it was generally believed its use would be limited.

“The idea was to hit it hard and hit it early,” Fauci said Wednesday.

Now research has shown that the drugs do not eradicate the virus but merely hold the disease in check. When drug therapy is stopped, the virus tends to spread rapidly. This means that to control the virus a patient may face a lifetime taking the drugs, and such long-term use causes the toxicity risk to become a major possibility.

Fauci said long-term use of the antiretroviral drugs causes some patients to develop “sky-high” total cholesterol readings and to develop heart disease at an early age.

Additionally, long-term use can result in a patient’s virus developing a resistance that makes the drugs no longer of value.

Hit Hard, But Later

Fauci said the new drug guidelines still recommend to “hit it hard,” but later in the course of the disease.

Formerly, the guidelines recommended starting antiretroviral treatment in HIV patients who had no AIDS symptoms when CD4 cell counts drop below 500 cells per cubic millimeter. The new guidelines call for therapy to start when the CD4 count has dropped to 350 cells per cubic millimeter.

CD4, or “helper T-cells,” are white blood cells that are the primary target of HIV, the virus that causes AIDS. These cells decrease steadily with the advance of disease. A patient with low levels of these cells are at high risk of contracting infections that normally would be controlled easily by the immune system.

The new guidelines also change the therapy starting point based on a measure of the number of HIV virus particles in the blood stream.

Earlier guidelines called for drug therapy to start when the viral load reached 10,000 viral copies per milliliter of plasma, based on the branched DNA test, or 20,000 viral particles using the RT-PCR test.

New guidelines call for delaying drug therapy until the viral load gets to 30,000 in the branched DNA test, or 55,000 viral copies in the RT-PCR test. This means that the therapy would start later in of the disease.

The branched DNA test and the RT-PCR test are different methods of measuring the level of virus in the bloodstream.