San Francisco Examiner - July 11, 2000
ULYSSES TORASSA, The Examiner Staff

The idea is being touted as one way to make it easier for people in the developing world to get access to the life-saving drugs, which cost several hundred dollars a month and must be taken indefinitely. The practice could also reduce the drugs' toxic side effects, and lengthen the time a patient can be on a particular drug regimen before it fails.

Such new approaches are needed as it becomes apparent that ridding the body of HIV is virtually impossible, leading researchers told delegates Tuesday at the 13th International AIDS Conference.

"We're not going to cure HIV with the present drugs, so we need long-term strategies," said Canadian AIDS researcher Mauro Schechter.

Ultimately, scientists agree, a vaccine to prevent and perhaps even treat HIV infection will be the answer.

Just after the researchers spoke, the head of the world's leading AIDS vaccine agency announced the start of the first human trials to test the safety of a vaccine developed specifically for Africa.

But even if everything goes perfectly, International AIDS Vaccine Initiative President Seth Berkeley said, the earliest a vaccine could go on the market is five to seven years.

Meanwhile, several researchers have been studying the idea of stopping drug therapy for a time, partly in hopes of provoking a stronger response from the body's immune system. Results so far have been mixed, with clear signs that the virus bounces back fairly quickly after medicine is stopped.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told of a preliminary study involving patients who had already responded well to anti-retroviral drugs. In one case, patients were given drugs for two months and then had a month off. The amount of virus in their bloodstream went up as expected each time they stopped therapy, but it rebounded to a progressively lower amount each time.

In another study, the patients were put on a one-week-on, one- week-off schedule and also saw the virus come back when they went off therapy. But Fauci said the level of virus was quite low.

Regimen a hit among patients

"One might be able to interrupt therapy at regular cycles, such that the patient may be able to be without therapy for a substantial fraction of the year, perhaps even for six or eight months," Fauci said.

He pointed out that the studies involved only a small number of patients and that it's too early to know whether the regimen produces long-term benefits or leads to drug resistance.

But the strategy has proven to be a hit among those who have been tethered to a rigid schedule of drugs and their unwanted side effects.

"The patients are absolutely delighted at the idea of having halved their time in therapy. Adherence is really extraordinary," he said.

But he and other scientists warned that the regimen must be followed precisely and monitored closely to guard against creating a resistant virus. It is already known that people who do not take their medicines strictly as prescribed can develop a strain of HIV that is beyond the reach of available medicines.

That suggests the technique might not be the low-cost solution for developing countries that some hope. Laboratory tests to check patients' response to the drugs and whether they are becoming resistant cost from $150 to $800 and must be done frequently.

Indeed, the limitations of using anti-retroviral drug regimens in the developing world were highlighted Monday with the release of data from Uganda and Ivory Coast, where small-scale trials of anti-retrovirals are going on. In Uganda, the subjects have to pay for the drugs themselves, which costs about $250 per month at a reduced price negotiated through the United Nations, according to Raymond Mwebaze, a Kampala doctor. As a result, the patients are almost always wealthy or middle-class people, and even they have had to sell property, drain their savings and move out of their houses to afford the drugs.

Many participants dropped out during the 18 months of the study. Many only filled the initial prescription and never returned.

'Cost is not the only issue'

A significant percentage already have demonstrated resistance to at least some of the anti-AIDS drugs.

"The studies demonstrate that cost is clearly not the only issue in delivering drugs to developing countries, and that we have to address many of the same challenges here as we do in the U.S.," said Helene Gayle, head of HIV, sexually transmitted diseases and tuberculosis prevention for the U.S. Centers for Disease Control and Prevention.

Like many African doctors, Mwebaze expressed ambivalence about bringing anti-retroviral drugs to the estimated 25 million infected people in Africa.

"That benefit should be offered to every HIV-infected person, although our numbers are quite overwhelming," he said. In fact, follow-up on the relatively small study of fewer than 1,000 was difficult because of lack of manpower.

"You'll find there are very few clinicians available to do the monitoring," he said.

000711
SE000712

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .