Disappointing Results Cancel AIDS Drug Therapy Study

By LAURAN NEERGAARD Associated Press

WASHINGTON — HIV patients shouldn’t take breaks in their drug treatment. That’s the message from U.S. researchers who halted a major international study that found on-again, off-again medication far riskier than using high-powered AIDS drugs all the time.

Patients who took their medicine only when their immune systems waned were more than twice as likely to get sicker or die as people who took the drugs every day. So concluded a routine safety analysis of the study, which had enrolled more than 5,000 HIV patients in 33 countries when the National Institutes of Health halted it.

The finding is a blow to AIDS advocates who had hoped that drug- conserving therapy would reduce side effects — and save money on the expensive medications, particularly in the world’s poorest countries, where AIDS is skyrocketing.

“All around, it’s disappointing news,” said Jose Zunica, the president of the International Association of Physicians in AIDS Care.

He cautioned that the idea of drug-conserving therapy shouldn’t be shelved permanently: It might work one day, when there are newer, even more potent anti-HIV medicines.

Combinations of potent anti-HIV drugs help patients live longer, and slow the disease’s progression from HIV infection to full-blown AIDS. But the combinations can cause serious side effects; it’s inconvenient to take several pills a day, and the drugs are expensive.

Although treatment guidelines back continuous therapy, earlier small studies had suggested that it might be possible to take medication breaks and still control the virus. So the NIH funded a bigger study to see whether those early results were real.

Called the SMART trial, for Strategies for Management of Anti- Retroviral Therapy, it randomly assigned volunteers to take their medicine continuously or only when key immune cells called CD4s dropped to a certain level.

Not only did that strategy not control the HIV virus, there was an increase in side effects affecting the heart, kidney and liver in patients taking the drugs only episodically, the NIH said.

NIH officials notified doctors in the study last week to begin telling their patients about the results and to recommend full-time dosing.

NIH SMART trial info:

www3.niaid.nih.gov/news/newsreleases/2006/smartqa06.htm