Benefits of new drugs pose unexpected dilemmas

Questions regarding disability, preventive therapy, empty beds

In Miami, a 30-year-old man whose bouts with AIDS forced him to quit his job two years ago is now working again. Should he tell the government and risk losing his disability benefits, which he might need if his new drug regimen fails him?

In Baltimore, an AIDS patient went on preventive therapy for Mycobacterium avium complex (MAC) when his CD4 counts dropped below 200. After a month on combination therapy, his CD4 counts are topping 500. Should be go off MAC prophylaxis, which until now was considered lifetime therapy?

In Atlanta, an AIDS hospice has watched its census drop dramatically in the past six months. Should it close one of its units and switch its focus to oncology and elder care patient-sitting, knowing that a sudden reversal in AIDS cases could leave patients without adequate hospice services?

These good-news scenarios are some of the unanticipated dilemmas created by the new HIV drugs that are changing the care of AIDS as the epidemic enters its 16th year. In hospitals across the country, AIDS wards report their lowest censuses in years as patients respond to combinations of the nine antiretroviral drugs now available.

AIDS rates lowest in years

Indeed, data released last month by the New York City Health Department at the Fourth Conference on Retroviruses and Opportunistic Infections in Washington, DC, showed that the number of AIDS deaths in the city dropped 30% between 1995 and 1996. The Centers for Disease Control and Prevention, which compiles national data, will not have overall figures until later this spring, but New York’s experience is shared by other cities.

"When I talk to my colleagues around the country, everyone is witnessing an enormous decrease in the number of patients hospitalized with AIDS," says John Bartlett, MD, chief of infectious disease at Johns Hopkins University School of Medicine. "The AIDS wards have a very low census."

A two-year study of AIDS patients admitted to a Los Angeles clinic showed that the average number of hospital days used per month dropped by 57%, from 122 days to 52 days. By the end of 1996, the mean number of HIV patients receiving home care fell 93% — from 67 to 5, according to data presented at the conference.

"Our hospital days began to drop when we started prescribing double combination therapy with AZT and 3TC, but they dropped farther — and faster — when we added protease inhibitors to patients’ regimens," said Peter Ruane, MD, an AIDS researcher at Tower Infectious Disease Medical Associates in Los Angeles.

Patients who were too sick to get out their beds are now going back to work, contemplating future relationships, dusting off their dreams. Yet everyone is holding their breath, unsure how long the good news will continue.

"One of the doctors on our board remarked that on New Year’s Eve he had only one patient in the hospital," says Anthony Braswell, RN, MPH, director of AID Atlanta, the South’s largest AIDS organization. "A year earlier he wasn’t able to do anything for New Year’s because he had something like 20 patients in the hospital."

Braswell noted that an AIDS hospice facility whose board he serves on is facing a financial crunch because its patient volume has plummeted in the past several months.

"The dilemma is, we have to keep the doors open because these drugs will not work for everybody and we know this disease will come back," he explains. "If we don’t, we will be in the same spot we were in four years ago when there weren’t enough hospice beds and home care in this city."

HIV care now includes well-patient care

As for those patients who are no longer sick in bed, many are unsure how to proceed with their lives, Braswell says.

"There is a whole new part of HIV we have to look at now, which is well-patient care for people who have bounced back from being very sick," he says. "The problem is that their benefits are tied to their level of illness, so you have a whole group of people who are getting better, but their benefits could be exhausted if they say anything."

In some cases, providers are telling patients not to go back to work and jeopardize their benefits, Braswell says. "That doesn’t mean they should have to sit on their couches. They can go out and volunteer somewhere, get out in the community."

The Social Security Administration (SSA) has only recently begun to consider whether this phenomenal reversal in health for AIDS patients may necessitate changes in its disability guidelines, says Bill Debardelaben, spokesman for the SSA’s regional office in Atlanta.

"We have the expectation from talking to people on the front lines this issue will start to occur with these new drugs," he tells AIDS Alert. "But we have in place extended periods of eligibility for intended recovery, and those guides would fit any situation that might result from the implementation of these new drugs."

Under SSA disability regulations, beneficiaries can lose benefits only if they have medically recovered, and AIDS patients now are considered unable to medically recover. Therefore they are exempt from medical condition evaluations required of other disabled people who go back to work, says Mary Simmons, team leader in the Center for Disability Operations in the SSA’s Atlanta office.

All disabled people must report to the SSA when they do return to work, SSA officials warn. However, those people disabled by AIDS can get an extended period of eligibility of 36 months, following a nine-month trial work period. During that 36 months, they will receive their social security disability insurance (SSDI) benefits for any month in which earnings are $500 or less. After 36 months, benefits will be terminated the first month a person’s income exceeds $500.

Simmons was unaware of any SSA changes in the works for re-evaluating disability for AIDS. "We do know there have been a lot of treatment breakthroughs, but we are not hanging our hat on experimental drugs. It has to be time-proven," she says.

That doesn’t mean change won’t come. Until four years ago, patients with CD4 counts below 200 automatically qualified for disability. CD4 count was removed from the criteria once it was shown not to be a good indicator of disability.

Although the SSA has a process for expediting disability approval for extremely sick patients, the process can take up to two years. That would be too long for a patient who had gone off disability and suddenly stops responding to the new drugs, Braswell says.

"Everyone is aware of this problem but no one knows what to do," he explains. "If these drugs were approved under the traditional FDA approval process, we would have seven years of data to base a decision on. But we only have one or two years, and whatever changes the government would make would be pretty permanent changes."

Patients and providers are confronted with a different sort of problem for which there is little precedent. For more than two years, health officials have recommended that an AIDS patient whose CD4 count dips below 200 cells should go on preventive therapy for MAC.

Recently, Bartlett was presented with a patient whose CD4 counts had dropped to 10 cells and had developed disseminated MAC. After treatment with protease inhibitors, his CD4 count jumped to 500 cells.

"That is an amazing recovery," Bartlett says. "The question is: Should this patient stop taking treatment for MAC? Once we start that treatment we never stop it, but we decided in this patient we probably can."

T-cell repertoire may be incomplete

Such decisions, however, are made without adequate knowledge of just how well the immune system has been restored. A recent study of AIDS patients with low CD4 counts has shown that certain types or clones of CD4 cells are not replaced, even if the immune system improves with treatment.

"Prophylaxis for opportunistic infection may remain important for patients who have rising T-cell counts but may be missing part of their T-cell repertoire," warned Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, who presented the study results at the Fourth National Conference on Retroviruses.

On a more positive note, two studies presented at the conference indicate that early therapy with two protease inhibitors is associated with improved immune function. Investigators at the University of Ottawa discovered that combining ritonavir and saquinavir partially restored immune systems in 43 patients. Preliminary 12-week results of the study showed increased circulating naive and memory CD4 cells and naive CD8 cells, as well as decreased immune activation and improved lymphocyte function.

Indeed, what experts may soon recommend is that for some AIDS-related diseases, such as primary multifocal leukoencephalopathy and possibly cytomegalovirus, the best treatment may be protease inhibitors, says Bartlett, "not because of what they do to the virus, but what they do to restore the immune system."