Protease inhibitors are changing formularies

AIDS care shifts to disease management

Cancelled medical appointments, sudden panic over long-neglected financial affairs, even thoughts about returning to work: These are the realities for many AIDS patients who had previously resigned themselves to death but who now find they’re feeling well enough to make plans for the future. The reason: protease inhibitors, powerful drugs rushed to market in recent months, that attack the HIV protease enzyme and thereby reduce the amount of virus in the blood.

"My public benefits counselors say a full one-third of the callers say, ‘I’m feeling so good I wonder if I should go back to work?’" says Jacques Chambers, manager of the benefits program at the LA Aids Project in Los Angeles.

Powerful agents for change

But while AIDS patients are benefiting mightily from protease inhibitors, early indications are there’s trouble ahead for some medical providers who have built businesses around the disease. In many large metropolitan areas, hospital pharmacists can expect swift shifts away from drug protocols used to treat the very ill or dying AIDS patient. Whereas formally, AIDS patients were frequently hospitalized with pneumonia, thrush or Kaposi’s carcinoma, many of those on the new protease regimens are not developing these diseases.

Peter Ruane, MD, an infectious disease physician at the Tower Infectious Disease group in Los Angeles, says he has seen a drastic reduction since June 1994 in many of the barometers used to measure the health of AIDS patients.

For example, outpatient referrals at his practice for radiation therapy (for Kaposi’s sarcoma and other cancers) have fallen 80%. Hematology/ oncology referrals are down by a third, GI referrals have been halved, and there has been a drastic reduction in the number of cytomegalovirus (CMV) retinitis cases.

Hospitals, especially those that beefed-up facilities in the wake of the AIDS epidemic, have experienced a similar quick deflation of AIDS-related business. Ruane says he’s seen the average number of days AIDS patients spend in a hospital drop by more than 50%; skilled nursing days per month have dropped by two-thirds over the past 18 months.

If Ruane’s figures hold, it could mean wholesale layoffs of nurses and possibly some pharmacists in cities with large AIDS populations. At the very least, hospital pharmacists will be scrambling to bring drug and equipment inventories in line with dropping demand.

Robert Neger, an ophthalmologist in San Francisco, cautions that it’s too early to tell whether protease inhibitors will prevent CMV but says he’s seeing patients less frequently these days and even had a previously CMV-positive patient refuse a recommended ganciclovir implant because he was feeling so good.

And while the protease inhibitors seem to be doing a good job, Neger worries that their immaturity in the marketplace may catch up with them, especially because patients taking them are now refusing to participate in studies. "Once a drug is approved, clinical data is stopped," he says. Because the protease inhibitors were rushed to market, Neger says he’d like to see a data bank of patients on the drugs to help detect any latent problems.

Effects ripple through continuum of care

Doctors aren’t the only ones losing money from the effects of the protease inhibitors. Entire industries have been built around AIDS’ long goodbye — especially home health care and outpatient infusion corporations, which are often staffed by pharmacists. Ruane’s figures show a stunning drop in the average number of his patients needing home health care, from 67.6 in 1994 down to 28.7 in the first six months of 1996. Figures for the second half of 1996 have yet to be compiled, but Ruane expects impressive results, with the mean number dropping, perhaps, below 10.

And the good times may be nearing an end for pharmacy corporations supplying IV nutritionals, Ruane’s figures suggest. Demand for hyperalimentation solutions is down 71%. "You know, now that you mention it, I have [seen a drop-off]," says Belinda Abrams, BS, RPh, of the Pharmacy Corporation of America’s Atlanta facility. "I don’t have nearly as many AIDS patients as I used to have. At one time, we had quite a few on antibiotics," she adds. "Now we have just one on ganciclovir over the past three or four months."