VIRUSMYTH HOMEPAGE

U.S. PANEL SEEKS CHANGES IN TREATMENT OF AIDS VIRUS

By By Lawrence K. Altman

The New York Times 4 February 2001

Altering a long-held policy, federal health officials are now recommending that treatment for the AIDS virus be delayed as long as possible for people without symptoms because of increased concerns over toxic effects of the therapies.

The new guidelines, written by a federal panel and due to be announced on Monday, represent a major philosophical shift in treating H.I.V., the AIDS virus.

Instead of the "hit early, hit hard" approach in effect since 1996, the new approach calls for waiting until the immune system shows serious signs of weakening or H.I.V. levels in the blood far exceed those for which treatment is recommended.

The panel, convened by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation, still recommends therapy for anyone who develops symptoms of AIDS. Therapy should also be given to people whose blood tests show they have been infected for less than six months, in the belief that early treatment might strengthen the immune system's ability to fight the virus, the panel says.

Such guidelines have no force of law. Wide-scale application would mean that some infected people might defer costly therapy for up to three years and ultimately decrease the risk of the toxicities, said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.

The aggressive approach to treating H.I.V. was adopted shortly after protease inhibitor drugs were marketed and then combined with older drugs in 1996. These drug cocktails, which suppress the amount of H.I.V. in the blood beyond levels that tests could detect, led to substantial responses, with many AIDS patients getting off their deathbeds or going back to work. And many experts advocated early treatment for healthy infected people to prevent damage to the immune system.

A few virologists raised hopes that in a short time the drugs might eliminate H.I.V. from the body, thus achieving a cure and obviating any drug therapy.

But studies show that the drug cocktails do not cure H.I.V., and when infected people stop therapy, the virus rebounds, making lifetime therapy necessary.

More recently, concern has grown over nerve damage, weakened bones, unusual accumulations of fat in the neck and abdomen, diabetes and a number of other serious side effects of therapy. Many people have developed dangerously high levels of cholesterol and other lipids in the blood, raising concern that H.I.V.-infected people might face another epidemic -- of heart disease.

The pendulum has swung from when few therapies were available and most people died from AIDS to a time when drug cocktails are effective but creating complications.

"We are adopting a significantly more conservative recommendation profile" that allows the virus to remain in the body longer in return for sparing the patient the drug toxicities, Dr. Fauci, who is co-chairman of the panel, said in an interview.

The guidelines call for delaying drug treatment until the level of CD-4 immune cells in the blood falls below 350 per cubic milliliter instead of the older recommendation of 500.

A second change relates to the H.I.V. blood level as measured by two tests. The panel urged delaying therapy until the H.I.V. level exceeds 30,000 per milliliter in the so-called branched DNA test (instead of the previously recommended 10,000) and 55,000 in the so-called Polymerase Chain Reaction test (instead of 20,000).

The guidelines point up the many uncertainties and complexities of treating H.I.V. No studies definitively address the question of precisely when to start therapy, but the panel concluded that the toxicities have significantly tipped the balance between benefit and risk against early treatment.

The report urges doctors to consider factors such as a patient's willingness to begin therapy and ability to adhere to it. Adherence can be difficult because infected people must follow a rigid regimen in which some drugs must be taken with food and others without it.

The panel said indirect evidence suggested that infected people do no better when treatment is started at a CD-4 count of 350 compared with 500, but that people who start therapy at CD-4 counts of less than 350 do not do as well as those who start when their count is 350 or higher.

"Much remains to be learned about how best to treat H.I.V.-infected individuals," said the panel, which is posting the guidelines at www. hivatis.org in conjunction with the retrovirus meeting here.

VIRUSMYTH HOMEPAGE