By Jim Schutze
By Rachel Watts
By Lauren Drewes Daniels
By Anna Merlan
By Lee Escobedo
By Eric Nicholson
But everyone acknowledges the excitement may be short-lived. Although most recent tests are positive, the drugs also have researchers cautious, because they are so new. Many researchers fear the virus is simply lurking somewhere in the body, mutating, and waiting for an opportunity to reemerge in even more lethal forms. The drugs also have problems with absorption, some side effects, and bad reactions to other drugs important to the health of AIDS patients.
And not everyone who has added a protease inhibitor to his medication regimen got better.
Robert, a 38-year-old Dallas resident diagnosed with the AIDS virus 13 years ago, also tried saquinavir a year ago. But he experienced severe side effects with the drug, including complete numbness in his mouth and some paralysis in his legs. Although Robert has long had a low T-cell count (below 10), he never showed symptoms of the disease. He decided to discontinue use of the drug. "I was not willing to make that change, to sacrifice my good health," he says.
Skip Barnes, diagnosed with HIV in 1988, began taking ritonavir earlier this month. He decided to add the new drug to his regimen after seeing "all the hype on the protease inhibitors, about how they were possibly a breakthrough. I bought into the hype."
His experiment did not go well. "Before I started taking them," he says, "I was doing great. I was working part time. And then I started taking the ritonavir, and it started with the nausea and the numbness in my mouth, and then my skin felt like it was on fire."
After four days, he discontinued the use of ritonavir. "I decided I'd rather not be this sick."
Barnes has since begun taking smaller doses and says some of the side effects have slightly abated. "I am going to try and give it another shot. I'm hopeful that something will come out soon that doesn't have the side effects. I keep taking it because the virus doesn't seem to like it."
Because the drugs have been tested for a relatively short period of time (less than two years), they are still a mystery in many ways. "We don't have enough data to know all the answers," says Pate. "We don't know who are the best people to give this medicine to, or how long the benefits will last.
"But," he adds, "they are very potent agents and they give us tremendous strategies that will decrease (virus activity)."
The emergence of protease inhibitors also raises troubling questions about who is leading the fight against AIDS, Dallas experts say. "The goal is--if you can't find a cure--to make AIDS a chronic disease," says Emerson. "The question now is, do the drug companies want to find a cure or do they want to keep it at bay? It stands to reason that economically they would make more money to make this a chronic disease rather than to find a cure. They really need an uninterested party--the federal government--to step inside and find a vaccine."
Pharmaceutical companies are scrambling to build manufacturing plants for the drugs, which can exceed costs of $6,000 a year per patient.
The drugs are so expensive the Texas Department of Health announced this month it would not provide funding for making protease inhibitors available to the poor.
"It's unfortunate," Pate says, "because AIDS is a disease of the poor."
Testing is intensifying across the country and Dallas AIDS researchers and doctors closely monitor the results. This summer, the Nelson-Tebedo clinic will begin testing "third generation" protease inhibitors, says research nurse Jack Emerson. "The newer inhibitors coming out are significantly stronger than the ones on the market today."
And when they come out, Lloyd Duncan will begin taking them. Duncan, 31, has a T-cell count of 0, but the indinavir (widely considered the best of the lot) he has been taking has kept his virus activity down to such a minimum that the disease has not been able to progress as quickly as would be expected. "My doctor and I have an agreement that as the more aggressive drugs come out, I will switch to them," he says.
Duncan remembers the first time he learned of the protease inhibitors, in AIDS Update, a newsletter put out by the Foundation of Human Understanding in Dallas.
"I remember thinking it would be great if it was true," Duncan recalls. "There have been all kinds of drugs that have come out promising all types of stuff and half of them don't even work.
"I do know, though, that for me, the protease inhibitors have definitely stood up to everything that they promised.