Bay Area Reporter - May 5, 2000
Jeff Getty, Survive AIDS Writers Pool

Though organizers were expecting some public interest, they were surprised to see over 150 persons attend the STI forum. According to event coordinator, Judy Leahy, the heavy turnout of the event made it the second best-attended forum she has ever put on. Survive AIDS' Hank Wilson said the event was remarkable, reminding him of the first HIV community forums of the mid-1980s.

So what's all the fuss about? Anyone taking HIV medications knows that sooner or later he or she must eventually stop the drugs or switch to a different combination. Such interruptions in therapy are common and have been ongoing since treatments became available. But in the last year a fair amount of data has surfaced about the effects of stopping and restarting medications. And some of the data indicates that STI might even be a good thing. Given that anyone taking HIV meds long-term would likely want to take a break, but do so in a careful and controlled way, it's not hard to see why STI has become the hottest topic in today's HIV population.

At the recent retrovirus conference no less than 17 abstracts appeared discussing STI. It seems that HIV researchers are on the trail to STI discovery as well. Given all the recent findings, Leahy and others carefully selected an appropriate forum panel. Featured speakers at the event were the University of California, San Francisco's Dr. Steven Deeks, who has recently published STI data; Dr. Jeff Harris, an immunologist who studies STI; Project Inform's Ben Cheng and Martin Delaney; and Survive AIDS' Matt Sharp.

The medical experts presented and discussed recent findings about STI. Deeks's own study which involved virologic failures (folks who could not get their virus under control with available meds) showed that stopping drugs for 12 weeks led to increased viral load and lowering T-cells. But Deeks also discovered that many of his patients' virus reverted to "wild strain" - meaning the virus became more like it used to be, before ever being treated. This finding was most tantalizing since a patient may be able to "reset" his virus to wild strain and then possibly have good results when resuming treatment. Deeks's findings indicated that wild virus was likely more "fit" and therefore could cause more havoc to the immune system.

Havoc or stimulation? Though Deeks's findings do not bode well for late-stage AIDS patients, the idea of allowing the HIV virus to fully impact the immune system without any drug-related suppression has some scientists excited. One abstract from Massachusetts General found that patients who went off drugs and then restarted, had increased cytotoxic T lymphocytic (CTL) activity against HIV. Other studies have both verified and disproved these findings. This "vaccine" effect has many patients and doctors intrigued. Could stopping drugs lead to better immune response further down the road? Perhaps, but in what population and by what guidelines?

Harris mentioned that he is currently enrolling a new study to find out what parameters one should follow if planning a STI. Harris found the forum to be very interesting. "It came off quite well with a lot of personal stories being told about individual STI," Harris said. But Harris is worried about self-experimentation and is rushing to find some answers. In his study, patients are being recruited who were otherwise going to go off medications - he is not encouraging anyone to suddenly stop their meds. Study participants should not ever have had a T-cell count below 100 (<100 nadir) and have some idea what their highest viral load count was. Given previous data, Harris expects to see nadir T-cell counts and all-time-high viral loads occurring when patients are off drugs. Patients may require additional OI prophylaxis when T-cells drop.

Recent published findings from Dr. Richard Price's San Francisco STI patient group also showed that some patients experience 2 or 3 log increases in cereberalspinal fluid (CSF) HIV RNA levels, meaning that STI could lead to major HIV infiltration of the central nervous system. Along with increased HIV, Price found increased white blood cell levels in CSF, meaning more inflammatory response (some believe this process could be one of the causes of dementia). Such possibilities should not be taken lightly. Two patients from the forum audience mentioned that when on STI, they saw signs of returning dementia. "I can tell you this, we are certainly going to encourage our patients to get lumbar taps [to check spinal fluid] as part of Dr. Price's ongoing study, in our study," said Harris.

Delaney presented slides explaining why and when a patient might consider a drug holiday. He reasoned that patients might want to let their bodies rest and heal, or create a vaccine effect on the immune system, or that some patients have to stop their meds because of drug side effects. As usual, Delaney's Project Inform approach was to weigh the pros and cons of STI and leave it up to the patients and doctors to decide the best strategy. "Marty's handouts were quite informative and helpful," remarked panelist Sharp. Neither Delaney nor the other panelists recommended STI regimens at this early stage. All agreed that more information is needed to discover likely safe parameters for drug interruption.

During the nearly two-hour forum over 30 questions were fielded from audience members. Leahy remarked that a lot of the questions came from people who were either thinking about taking a drug holiday or had already stopped meds for one reason or another. Wilson and others were very interested in gathering anecdotal information from people who have attempted a STI and have begun re-treating. "We want to know what their numbers [T-cell and viral load] were before, during, and after STI," said Wilson. Wilson encouraged patients who have stopped and restarted meds to call Survive AIDS at (415) 252-9200 and leave a message for him. Wilson will then call the person back and take down their information regarding personal STI. "This way we get to study our own data from a large cohort," said Wilson.

Project Inform's Cheng mentioned that other physicians are gathering experience data from at least eight large cohorts of patients from around the country. "We are going to start having some better answers soon," Wilson remarked.

Planning a drug holiday?

Deeks and others remind us that late-stage AIDS patients would be taking huge risks by going off medications (healthier patients face less risks). But in some cases one must stop treatment due to severe toxicities or treatment failure. In these cases there can be a brief holiday or washout between ending old drugs and starting new ones. Deeks cautioned that one should be checking their T-cells and viral load every two weeks during drug interruption. As soon as viral load appears and T-cells begin to drop, he recommends restarting new therapies. But if their is no cause to stop, and one's old drugs appear to be working, Deeks thinks it would not be wise to stop therapy. "If it ain't broke, don't fix it," Deeks recently told reporter Bruce Mirken.

Patients and doctors planning STI also can contact Harris at (415) 695-3818, ext. 1, for consultation advice. Harris likely will have emerging data in coming months that may be essential to know in STI planning. Patients interested in joining Harris's study can call the above number or e-mail him at jharris@itsa.ucsf.edu. To get copies of Delaney's handouts call Project Inform's hotline at (800) 822-7422.

Wilson reminded people that one good reason to stop drugs is because some people will feel much better. "This is something that the experts always fail to mention," he said. Wilson's candor correctly surmises why most patients want to initiate STI in the first place. The drugs are nasty and cannot be tolerated indefinitely. If taking a break doesn't hurt, and may even help, expect this new trend to take hold quickly. But it will most likely be up to pure researchers and the community to find out what is the best and safest way to go about it.

"Don't expect the drug companies to fund research about stopping medications anytime soon," mentioned both Sharp and Delaney at the forum.

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