The Miami Herald, Inc.; a Knight Ridder publication. One Herald Plaza, Miami, FL 33132-1693 - Sunday, December 22, 1996 Edition: Final Section: Front Page: 1A Word Count: 2,761
Peggy Rogers and Stephen Smith , Herald Staff Writers

TEXT: Five years ago, Mitchell Ciminelli thought he was dying. He closed his construction company, gave away his home and spent $130,000 living out his dreams.

Then something miraculous, and terrifying, happened. Death granted Ciminelli a reprieve. Reinvigorated by groundbreaking new drugs, he faces the joys and pains of life once again.

"When my doctor told me I was going to live, I said, `You're crazy,' " recalled Ciminelli, of Fort Lauderdale. "I have been waiting all these years to die. So don't tell me now -- when I've given up everything I had -- that I'm going to live."

For 15 years, AIDS defied effective treatment. The illness ran one course: decline and death.

The calculus forever changed with the advent of critical new drugs, known as protease inhibitors. In use now for a year, in combination with other potent pills, they are delivering new life to people like Ciminelli, 39.

But for how long? It is too early to say. This much is for sure: The new drugs are changing the profile of the epidemic, the automatic prognosis of death and the outlook of the afflicted.

Uncertainty haunts the newly healthy: Will they be prematurely dumped from disability plans, forced back to work? Will they be bankrupted by drug regimens costing $20,000 or so a year? How do you hold on to reason when confronted by headlines speculating on the end of AIDS?

"All it took was the protease to throw a monkey wrench into the whole thing. Everything has changed," said Fred Schaich, an AIDS patient and Fort Lauderdale founder of an international AIDS agency. "I can guarantee you that I have seen people return from the dead. That doesn't mean this disease is over."

The best and worst of American medicine can be viewed in this one advance, with repercussions for much of society:

* The patients. The drugs work for some people, like Stephen Freeman of Fort Lauderdale, who can now contemplate buying a house and returning to work as a nightclub disc jockey.

But other patients don't improve or can't tolerate the side effects. The new drugs are affordable for some, but not for others. The emotional ups and downs are nerve-rattling. "The optimism is making people crazy," said Larry Harmon, a Coconut Grove psychologist.

Some, expecting to die, amassed debt for treatment or final flings. "People have run up credit cards," Harmon said. "People have sold life insurance policies for $100,000 and spent it all on a fabulous time. And there's nothing left."

* The doctors. Many are cautious because they have seen patients start to slip backward. But they gain inspiration watching patients re-create their lives.

"It's an exciting time we're living in," Coral Gables specialist Dr. Stephen Santiago told a group of AIDS patients. "It's wonderful to be able to offer hope. Desperation led some of my colleagues to leave this kind of practice."

* The people at risk of contracting the disease. They see the good news about the drugs, but not the uncertainties. As evidenced by an alarming infection rate, people may be losing their fear of AIDS.

"The idea that HIV is an OK thing to get because all you have to do is take some pills is dangerous," said Dr. Helene Gayle, AIDS expert for the U.S. Centers for Disease Control and Prevention. "The reality is, prevention is always better than cure."

* The public. Given the tremendous drug costs and complicated regimens, Florida health authorities must decide how many and which people can be helped.

One protease inhibitor, Norvir, must be refrigerated, making it difficult for the homeless. A second, Crixivan, must be ordered by mail. The third, Invirase, is considered the most accessible but least effective.

* The insurance industry. As infected people live longer, disability plans worry about their costs increasing. And that leaves advocates and patients asking: When will the disability checks stop coming?

"Once you reverse the decline in health, at what point does it mean you no longer qualify as disabled?" said AIDS education manager Vince Tamburelli at Fort Lauderdale's Broward House agency. "If people are no longer receiving benefits, how are they going to be able to afford the drugs to maintain their health?"

* The medical industry. A few years ago, Mercy Hospital in Coconut Grove was treating an average of 45 AIDS patients at any time. The average is now about 10, said Shed Boren, Mercy's special immunology services director.

Another hospital invested in an AIDS medical practice, expecting to admit more patients.

"Whereas before, I might put 15 people into the hospital every month, now I might put one in," said Santiago, one of the doctors in the practice. "Now, the hospital is not too happy. I'm thrilled about it, and so are my patients, obviously." Progress was slow

Since its emergence in the early 1980s, AIDS proved a wily foe, mutating into increasingly virulent forms. Even when scientists triumphed in unlocking the viral code, they couldn't figure out how to use it to eradicate HIV.

A few drugs slowed the spread, but did not halt it. At one point, AZT was trumpeted as the answer, but it proved too weak to crush the virus. Time after time, what looked like stunning advances proved illusory.

Then, competing drug companies locked on to a class of drugs called protease inhibitors. They stop formation of an enzyme needed for the birth of new bits of virus.

On Dec. 7, 1995, drug manufacturer Hoffmann-La Roche received FDA approval for the first protease inhibitor, Invirase. Two others soon followed. More are in testing.

"This is the first class of drugs that we really, truly believe are going to have a great deal of benefit," said Tim Palmer-Pattison, a pharmacist who oversees HIV clinical research at the North Broward Hospital District. Combining medicines

The protease drugs are rarely used as a single-shot strategy. Instead, doctors combine them with other antiviral medications.

Each of the drugs aims at a different phase of the AIDS virus' life cycle, so the hope is that at least one of the drugs will succeed in burrowing into a virus particle and blocking its replication.

That is exactly what the treatment has done for Miami resident Bill Sullivan, diagnosed with the virus in 1988.

"I think people should say, `Hallelujah!' " Sullivan said.

Before he started on protease inhibitors, Sullivan's disease-fighting cells, called T-cells, were shot. His T-cell count was at one per millimeter, compared with the 500 to 1,500 count of healthy people. He had six million particles of virus per milliliter of blood.

Sullivan started on Norvir more than a year ago while it was experimental. Invirase was added later to his drug regimen. His T-cell count has risen to 144. His viral level dropped in August to a low of 1,600.

But the viral level recently climbed to 65,000, and Sullivan switched in November to Crixivan. A dose of realism

Because of the potential for such reversals, AIDS experts want to temper expectations.

"The scariest thing is having patients who have had increases in their viral load even though they're on this medication," said Dr. Cynthia Carmichael, a University of Miami AIDS specialist who treats patients in South Beach. "You don't want to dash people's hopes, but also you have to let them know this virus is a tough thing to deal with. There are still people dying."

Some people simply can't get the drugs.

Some insurers don't cover protease inhibitors. The AIDS Drug Assistance Program in Florida doesn't expect to start providing them until next year. And people have gone broke trying to pay on their own. "It makes people mad," said Teresa A. Scott, an AIDS advocate and mother of five who gets her drugs through Medicaid coverage.

"There are some people who can't or don't take the drug, and so it sits on the shelf and gathers cobwebs, and others who want to take it and can't afford it," said Scott, 38, who helps other patients in Miami.

Patients and grass-roots clinics have started unsanctioned drug exchanges. A clinic on Fort Lauderdale beach, Healthlink, receives the medications from people who can no longer use them and gives the drugs to those who can't pay. Helping others

Ken Harrison, 47, a full-time Healthlink volunteer and AIDS patient, said he has given his own drugs to others a couple of times, even knowing he may go without them for a few days, a dangerous practice.

With the protease inhibitors, the divide between the haves and have-nots is more pronounced than ever, said Angela Gaetano, HIV treatment and information coordinator at Health Crisis Network in Miami. "We have to make sure there's access so when we do find the cure, it's available to everyone."

Still, access to the protease inhibitors doesn't guarantee longer life. For some patients, the drugs prove more toxic than the disease.

Julia Llorente struggled for four months to overcome the fatigue and sickness that she experienced while on Crixivan. She hoped the drug would help her live to see her youngest son, 7-year-old Michael, grow up.

Several weeks ago, she stopped taking it. "I felt worse than when I wasn't taking it," said Llorente, 39, a member of Dade's HIV Health Services Planning Council.

Acie McNair, 44, tried two of the drugs, but that lasted only a few weeks. He couldn't stand the side effects and grueling regimen.

"You hear people saying they feel better, they have more energy. I wanted that. It doesn't work for me, and I have to accept that," said McNair, who volunteers at Health Crisis Network and is training to become a drug-treatment counselor.

"I may try again when I have the time, when I can stay at home and I can concentrate on taking the drugs correctly," he said. Drug reactions vary

Nothing is more important than following the prescribed treatment. Yet the drugs are so new and reactions so varied that even the experts struggle to create the correct combination for each patient.

"You can get four physicians in a room and get five different positions on when you start the antiviral drugs," said John Cochrane, clinical research manager at Community Research Initiative of South Florida, which has been coordinating research on the protease inhibitors.

If drugs are administered too soon, patients may develop resistance and have no alternative if their condition deteriorates. If given too late, immune-system damage may be too extensive to reverse.

"Use them judiciously and use them appropriately, but nobody knows what appropriately is," said Carmichael, the UM specialist on AIDS.

Doctors worry not just about the right timing for treatment, but also giving it to the right patients -- those committed to the regimen.

For patients who aren't diligent, resuming regular doses may be useless, and expensive drugs will have been wasted. Another complication: If someone who has taken the protease inhibitors infects others, that person may also pass on the drug resistance. Long-term prospect

"In many cases, you'd be better off not treating," the Broward hospital district's Palmer-Pattison said. "Before the protease inhibitors, there was some room to maneuver with missed doses or drug holidays, as some patients call them."

"With the protease inhibitors, there is none," he said. "This is something they're going to have to take every day, month in, month out, for a long period of time."

And patients who had come to accept their deaths must embrace life again.

"For many, many people, that may also mean the dilemma of having to plan for futures that they didn't expect to have," said Ann Prochilo, education director at Health Crisis Network, the largest AIDS agency in South Florida.

That colors their outlook on everything from employment to romance.

"Before, people would rush out and get into a relationship and say, `Maybe this is my last chance,' " said Stephen Fallon, education director at Center One, a Broward AIDS agency. "Now they're saying, `Do I want to be with this person for a decade?' " Unexpected turnabout

Thoughts of a future sent Mitchell Ciminelli into depression.

He had walked away from his successful construction firm on Long Island. He gave up his home, unsaddling himself from the $2,600-a-month mortgage.

He traveled. He moved to Fort Lauderdale. He drank heavily, racking up driving arrests.

"I was devastated," he said. "I had ruined my life. Every year, I thought, `This is it. This is going to be my last Christmas. I better enjoy it.' "

But the new drugs have brought him physical strength, and a new will.

"Before, I got to the point where I couldn't even walk up a flight of stairs. Now I can go running," Ciminelli said. "I'm thinking about work. I have to, I want to. I have all this energy. I have all these bills."

Days ago, a new worry arose for Ciminelli. For the first time, his health plan stopped paying for twice-monthly intravenous doses of an immune-boosting drug. Even though the plan still pays for the protease drugs, the insurer figured he did not need the additional boost anymore, Ciminelli said.

Around the nation, patients and AIDS experts are trying to brace for such consequences. Effect on insurers

Disability insurers say they are not starting to force AIDS patients back to work prematurely. But indefinitely sustaining patients out of work would have a huge impact on disability plans, industry members acknowledge.

"Frankly, AIDS is a concern to the industry," said actuary Tom Wildsmith, a policy research specialist for the Health Insurance Association of America. "In general, it's good for society and the people involved to have people who are physically able to hold a job re-enter the job market."

But nationally, the cost of supporting infected people currently represents no more than 4 percent of all private disability coverage, Wildsmith said. "It's real money, and I'm glad I don't have to pay it personally, but on the other hand, it's not going to bankrupt the industry."

Some people with AIDS have returned to work. Experts encourage it, when feasible. Coconut Grove psychologist Larry Harmon and his associates are planning sessions on resume-writing and job-hunting for recovering AIDS patients.

Others, suffering subtle but permanent brain damage from the virus, will never be able to go back to work, experts say.

Even in the era of protease inhibitors, staying alive is still the paramount pursuit -- and uncertainty -- for people with AIDS.

"The biggest fear in all of us is that, yes, the medications are doing good, but for how long?" said Ken Harrison, the Healthlink volunteer. "A year down the road, are we going to still be better, or are we going to be back where we started? We live on hope."

APPROVED DRUGS

The three protease (pronounced PRO-tee-ace) inhibitors now available gained federal approval between December 1995 and March 1996. Protease is an enzyme needed for the virus to colonize blood cells. If you stop the protease enzyme, you hobble that bit of AIDS virus.

The protease drugs on the market:

* Saquinavir (marketed as Invirase); made by Hoffmann-La Roche.

* Ritonavir (marketed as Norvir); made by Abbott Laboratories.

* Indinavir (marketed as Crixivan); made by Merck & Co.

A fourth protease drug -- Nelfinavir (marketed as Viracept); made by Agouron Pharmaceuticals -- is in late-stage trials and expected to win regulatory approval early next year.

CAPTION: color photo: Stephen Freeman lifting weights (a), Julia Llorente with son Michael Dominguez and grandson Juan Bonilla (a); photo: Bill Sullivan (a), A handful of AIDS drugs (a), Stephen Freeman (a), Mitchell Ciminelli (a), Mitchell Ciminelli (a-Ran in First), Teresa A. Scott (a-Ran in First), Acie McNair (a-Ran in First)

MIKE STOCKER / Herald Staff CONTINUING TREATMENT: Stephen Freeman awaits intravenous hookups at Healthlink in Fort Lauderdale. Freeman is now healthy enough to work out with weights, as seen in photograph on 1A. WALTER MICHOT / Herald Staff NEW HOPE: Mitchell Ciminelli got boost from new AIDS drugs. CHUCK FADELY / Herald Staff SIDE EFFECTS: Acie McNair reluctantly gave up treatment. CHUCK FADELY / Herald Staff DOING WELL: Teresa Scott has found help in her drug `cocktail.' MIKE STOCKER / Herald Staff WORKING OUT: Drugs called protease inhibitors have helped Stephen Freeman of Fort Lauderdale, who might return to work. CHUCK FADELY / Herald Staff REACTION : Julia Llorente, with son Michael Dominguez, 7, and grandson Juan Bonilla, won't take a drug that made her feel worse.

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