The San Francisco Examiner; March 25, 1998
Lisa M. Krieger, Examiner Medical Writer

"Treatment is a lifelong commitment, without mistakes," said Dr. Julio S. Montaner, lead investigator of the international study, published in the Journal of the American Medical Association. "Some chronic diseases are forgiving, like hypertension or diabetes. HIV disease is not."

San Francisco Mayor Brown announced the establishment of four pilot programs, staffed by nurses and social workers, to help San Franciscans adhere to treatment at Wednesday's 10th national AIDS Update Conference in The City.

These programs, affiliated with public health clinics or community groups, will dispense information, emotional support and devices like timers to help patients stick to treatment.

"Without adherence, there is no benefit - in fact, there will be harm," Brown said.

In the study, failure to stick to the regimen was shown to result in a resurgence of the AIDS virus in 18 of 22 patients on triple-drug combination therapy with AZT (zidovudine), DDI (didanosine), and a new drug called Viramune (nevirapine).

Of patients who did adhere to the regimen, 13 of 18 achieved complete viral suppression for over a year - a victory over illness that is likely to continue, as long as patients stick with the treatment, Montaner said. The potential payoff of rigorous therapy was further bolstered by a second nationwide study, to be released in Thursday's New England Journal of Medicine, which confirms that consistent use of anti-viral combination therapies has resulted in a massive 75 percent decline in death and disease due to HIV infection.

The findings of the huge HIV Outpatient Study from a dozen different research sites supports a growing body of evidence from North American and Canadian health departments that the number of AIDS deaths is falling.

"Our current understanding of the pathogenesis of AIDS . . . argues in favor of treating all HIV-infected patients, including those with nearly normal immune systems," concluded Swiss AIDS experts Drs. Bernard Hirschel and Patrick Francioli, who are also organizers of the upcoming 12th World AIDS Conference in Geneva.

New questions, problems

Although these results show a major achievement in the treatment of HIV infection, they also raise new questions and problems.

If patients face a lifetime of treatment, it is important to learn much more about the long-term complications and the safety of the drugs used to treat HIV, scientists say. Furthermore, the drug regimen can be expensive, complicated and sometimes toxic.

"What sounds like a small nuisance for a couple years is a major pain in neck for 10 to 30 years," said Montaner of the Canadian HIV Trial Network at St. Paul's Hospital at the University of British Columbia.

"It is a big mistake to coerce (a patient into treatment) before they are ready. It is more important to do it right, than do it promptly." Some triple-drug treatments using protease inhibitors are a particular problem, he believes, because they come with strict diet and scheduling restrictions.

But protease inhibitors may not be an essential ingredient of therapy. The regimen used in the new JAMA study did not contain a protease inhibitor, making it simpler and cheaper.

"Treat smart"

"The philosophy of "treat early, treat hard' in early HIV infection must now yield to a philosophy of "treat smart' for all stages of HIV infection," said Dr. Roy Gulick of New York Hospital-Cornell Medical Center in New York City, in an editorial accompanying the study.

Patients need to think carefully, consulting with their doctors, before launching treatment, Montaner and Gulick agreed.

The powerful drugs knock the virus way down but not out of victims' immune systems. Researchers suspect that hidden, inactive reservoirs of virus persist for at least a decade - and maybe a lifetime.

If this hidden virus is not allowed to multiply, it does not become drug-resistant, said Montaner. But a lapse in treatment allows the virus to proliferate - and in Darwinian fashion, the toughest, most drug-resistant strains survive.

"Almost invariably, lack of adherence leads to resurgence of viral load, replication, resistance," said Montaner. "As long as the virus is suppressed, emergence of resistance is not a problem."

"Long-term therapy is needed. Our most optimistic estimate suggests that at least a decade, if not life-long, therapy will be needed."

Early studies, which suggested that a patient could be pulled off treatment after one to two years, have proven wrong.

The good news is that as long as people infected with HIV keep taking the triple-drug cocktail, they have an excellent chance of surviving the infection for a long time, without developing symptoms of the disease, doctors say.

Hidden HIV does not appear to mutate into drug-resistant forms during the therapy. There had been initial fear that the hidden HIV would re-emerge at some point more virulent and less treatable than ever.

Drugs with new ways of attacking HIV will be important to the next major advance in treating the infection.

A survey by the Pharmaceutical Research and Manufacturers of America, which represents the nation's leading drug and biotech research firms, revealed that 40 anti-HIV drugs are in clinical trials or under FDA review.

"It doesn't matter if you have a big hammer," said Montaner, "if you don't keep hitting."

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