Three years after new medications revolutionized the treatment of AIDS, many patients are backing off their therapies because of side effects and the daily burden of taking dozens, even scores of pills.
Doctors say few patients are abandoning their drugs altogether, but acknowledge that many are missing or tapering their doses even if it means lowering their expectations of long-term survival. Some patients, with or without their doctors' approval, are taking "drug holidays" to gain relief from side effects.
Some, like restaurant manager Tim Leist, took about 50 pills a day to keep his infection in check. But the drugs, he said, caused intestinal and psychiatric problems that, at times, made it next to impossible to drive or get out of bed. Like many patients, he became resistant to one drug after another, forcing his doctors to prescribe new medications whose effects were also short-lived.
Now, with his doctor's blessing, he is taking about a third as many pills and is feeling better than he has in years, though he recognizes the virus may seize the chance to rebound.
"I'm probably on the lightest drugs I've been on in five years," said Leist, 38, who attends the AIDS clinic at Johns Hopkins Hospital. "My philosophy on this illness is that as long as I feel good day-to-day, I don't worry about the long term."
Faced with these problems, doctors are adopting a sober view of today's therapies for acquired immune deficiency syndrome -- saying it may not be realistic to expect patients to continue for many years on complicated drug schedules. The problem, they say, underscores the need for new treatments that are less toxic and simpler to take.
"It's one thing to take these drugs for a week or six months; it's another to do it for four or five years," said Dr. Robert Redfield, director of AIDS care at the University of Maryland Medical Center. "This is not a sustainable therapy for the majority of individuals."
Dr. Joel Gallant, director of the outpatient AIDS clinic at Johns Hopkins Hospital, said he remains optimistic about the ability of his most committed patients to stay on complex therapies for years. But he acknowledged that less than half the patients at Hopkins and other inner-city clinics can take their drugs faithfully and keep the virus at bay.
Since 1996, when doctors started using a class of drugs called protease inhibitors, AIDS deaths have steadily declined. The drugs, used in combination with other medications, enabled thousands of patients to return to work and stay out of hospitals. Many gained weight, lost their sickly pallor and rediscovered wells of energy.
Nationally, deaths dropped 25 percent in 1996 and 40 percent in 1997. But last year, the decline was 20 percent, triggering a recognition that drug therapy had its limits. Doctors said it would have been naive to expect the death rate to continue its steep decline without new breakthroughs in treatment.
"It can't keep going down and down," Dr. Douglas Richman, an AIDS specialist at the University of California San Diego, said in Baltimore recently at a conference organized by the University of Maryland's Institute of Human Virology. "We need better drugs and new things to supplement drugs."
Doctors who championed the new treatments made no secret that the medications posed problems. But today, many acknowledge that they underestimated the difficulties and were probably wrong to expect some patients to keep up with dosing schedules.
Patients often are required to swallow large amounts of pills at intervals throughout the day. Some pills must be taken with meals, others without. Some patients carry electronic timers that alert them to the next dose. But for many, the task is too complex. To make matters worse, patients who miss doses are more likely to develop resistant strains. Side effects include nausea, diarrhea and fatigue. Protease inhibitors can also raise cholesterol to dangerous levels and change the way fat is distributed on a person's body. Some patients get skinny arms and legs, distended stomachs and fat deposits called "buffalo humps" on the upper back.
Doctors decided that, for some patients, it is better to use drugs sparingly -- but consistently -- than to prescribe complicated regimens they are unlikely to take.
"The worst thing you can do is give these drugs to a lot of patients who can't take them," he said. "We're not only contributing to an epidemic of drug resistance but we don't do the patients any favors. We have to individualize therapy and not be afraid to withhold therapies in some cases."
Though the practice is controversial, some doctors have agreed to plan "drug holidays," brief periods when patients take a break from the drugs that are bothering them.
"I don't tell a patient to please take a drug holiday," said Redfield. "But in the third year of combination therapy, some are very honest. They need a rest. So they get a rest and then they come back enthusiastically into therapy."
Carefully conceived, he said, holidays can be taken without giving the virus a chance to evade treatment. Other doctors, including Gallant, said the practice is dangerous and should be encouraged only when patients are suffering intolerable side effects.
Patients who are thriving on the drugs say they have no choice but to structure their lives around medication schedules.
"My compliance may not be 100 percent, but it's 98 percent," said James Ball, a Hopkins patient on combination therapy. "It is frustrating, and I wouldn't be honest if I didn't admit that. It's part of your life, and you've got to treat it as a normal requirement."
Leist, the restaurant manager, says he used to have a swimmer's body but has developed a "beer belly" and "chicken legs" since taking protease inhibitors. These, he says, are mere annoyances compared to the intestinal problems and paranoia that overcame him when he was taking high doses of anti-viral drugs.
Now on simpler regimens, Leist says he has learned to enjoy every good day. "The only thing I can make sure of is that I take my meds, eat right and get enough sleep. The rest will take care of itself," he said.
Children missing doses
For children, life on anti-viral drugs can be daunting. Many want to spit out their pills and capsules. Liquid medications can taste bitter and metallic. But the biggest problem, according to some doctors, is the parents.
Dr. Douglas Watson, a pediatric immunologist at the University of Maryland Medical Center, said most of the youngsters are the children of drug addicts who suffer from AIDS. Many can't be trusted to make sure their kids swallow their pills.
In a recent study, Watson found that 42 percent of the children don't take their medications because their parents don't get the prescriptions filled. Though the hospital works with the parents, it sometimes fights to have the children placed in group homes or foster care.
"I have a legal obligation to report medical neglect to the state," Watson said. "The bottom line is that after a certain point, the parent doesn't have a choice of whether to give their child medication."
Pub Date: 9/13/99