Patients Welcome Experimental Halt in AIDS Drugs--but Virus Returns

WASHINGTON — A daring experiment--having AIDS patients stop taking their powerful drugs in the hope that their bodies could control the virus without them--has produced disappointing results: The virus comes back.

Researchers were not surprised. Even in patients such as these, where potent drug combinations had rendered the human immunodeficiency virus undetectable by the most sophisticated testing, scientists already knew that there were hidden reservoirs of latent HIV in the body. It was just a matter of time before the virus would rebound.

But the news has been painful for some patients who had entertained fleeting hopes of being able to stay off drugs and remain healthy indefinitely. That now appears unlikely.

“It would have been great, but did I really believe it, in my heart of hearts? No,” said Mark Deal, a 37-year-old hotel concierge from New Orleans and a participant in the National Institute of Allergy and Infectious Diseases study, one of several in the country.

“For me, it was a question of when the virus would pop back up and how long my ‘vacation’ was going to be,” he added. “I lasted a lot longer than most.”

Deal’s respite from the drug regimen lasted about five weeks; he stopped taking his 25 daily pills at the beginning of January, and by mid-February tests indicated that the level of HIV in his body had rebounded and the virus was again replicating. He recently resumed taking his medicines, and the virus is close to being undetectable again.

The study at NIAID, part of the National Institutes of Health, has enrolled 18 patients. Ten have gone without their drugs long enough to produce results; in all of them, the virus has come back.

“I would have loved it if my patients could have stayed off therapy, especially since I know how much better they felt in a drug-free state, but what happened was predictable,” said Dr. Richard T. Davey Jr., the NIAID researcher conducting the study.

Nevertheless, the experiment has opened rich avenues of research, he said.

No one predicted the drugs would eradicate the virus. Numerous studies, in fact, have indicated just the opposite: that decades of drug use would be needed if elimination of the virus were possible at all.

“The virus is deeply entrenched,” Davey said. “And recent research suggests it requires prolonged therapy--60 or 70 years--to eradicate the virus.”

In recent years, AIDS patients have lived longer and healthier lives with the help of these “cocktails” of antiviral drugs, combinations of older medicines and the newer, potent protease inhibitors. Together, the drugs deliver a multi-pronged punch to HIV, rendering it unable to replicate and carry out its destructive mission against the body’s immune system.

The drugs enable many AIDS patients to live in relatively good health. But they are expensive--costing up to $12,000 a year--and the regimen is cumbersome, requiring patients to take numerous pills on a rigid schedule, often revolving around meals. And the drugs have nasty side effects, including diarrhea and peculiar deposits of body fat.

AIDS researchers believe the experiment will help them learn more about patterns of viral comeback, whether the virus returns slowly or rapidly and in what amounts, and whether the body’s immune system can be primed to respond once it does.

The experiment could also offer insights about what it takes to keep HIV under control indefinitely.

All the information gleaned from these studies “now gives us more fuel to pursue ways of trying to block that reservoir pool of virus from ever coming back,” said Dr. Anthony Fauci, director of NIAID.

Dr. Robert T. Schooley, chairman of the federal government’s AIDS Clinical Trials Group and head of infectious diseases at the University of Colorado Health Sciences Center, agreed that these “still remain a very important set of experiments.”

“It’s not over yet,” Schooley added. “It just means that these first few isolated experiences aren’t going to tell us the whole story.”

Davey and his colleagues are conducting extensive tests on every patient’s immune system and analyzing each pattern of viral return.

Although the answers are not yet available, “it looks like there are different patterns of relapse,” Davey said. “In some patients, the virus goes gangbusters and rises to high levels. In others, it seems to fluctuate over a period of time” after returning.

“The acid test is what’s happening to the virus--and in the absence of drug therapy, the fact that the virus is coming back quickly suggests that the immune response is not strong enough to control it,” Davey said.

But from a positive standpoint, the drug break apparently doesn’t hurt “because when you put patients back on drugs, the virus goes right back to undetectable levels,” Fauci said.

This is good news for Deal and others like him. Deal has done well on the drugs, although he hasn’t ruled out trying a new drug combination, with possibly fewer side effects.

Nevertheless, knowing that a respite from drugs apparently won’t give the virus the edge is reassuring; maybe he can take a break periodically with no ill effects.

“If the picture were the same for me, clinically and medically, yes, I could see myself saying a year or two from now, ‘I’m going to go hike the Appalachian Trail and ditch the drugs for a month,’ ” he said.

For now, however, Deal has resumed his old pill regimen and refuses to look back.

“I’ve been unbelievably lucky,” he said. “I still feel like I’m going to be here for a long time, although I’m probably going to have to take 25 pills a day to do it. I’m not going to get mad at God for that. Life is not terrible because I have to swallow 25 pills a day. Life is great because I’m still waking up every day.”