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Simpler HIV Therapy Isn't Always Better

Study: Less-complicated regimen not as effective

WEDNESDAY, April 28, 2004 (HealthDayNews) -- When it comes to treating HIV, the old adage "less is more" definitely doesn't hold true.

A study in the April 29 issue of the New England Journal of Medicine reports that a simple drug regimen combining three medications -- AZT, lamivudine and abacavir -- into one pill wasn't as effective in controlling HIV as other treatment regimens in the study were.

"This was a large study designed to look at what the best treatment to start with is for HIV infection," said study author Dr. Roy Gulick, director of the Cornell HIV Clinical Trials Unit at New York-Presbyterian/Weill Cornell Medical Center in New York City. "We compared three treatments and found that one of the three was performing inferiorly. The rate of failure was about 21 percent compared to about 11 percent in the other groups."

Gulick and his colleagues enrolled 1,147 people with HIV to receive one of three different, randomly assigned treatments. None of the study participants had received any antiretroviral therapy before the study. The researchers deliberately didn't include medications known as protease inhibitors in the study because, though effective, they can have more troublesome side effects, such as nausea and vomiting.

The three different drug regimens used in this study were: AZT, lamivudine and abacavir, which is sold under the brand name Trizivir; Trizivir plus efavirenz, brand name Sustiva; and Sustiva plus a combination of AZT and lamivudine, marketed as Combivir.

All of the study participants took seven pills daily; some were placebos, so the participants and the investigators didn't know who was taking what medication until the end of the study.

Eighty-one percent of the study participants were male and 60 percent were non-white. The study period was supposed to last for 96 weeks.

After 32 weeks, Gulick says an independent safety board from the National Institute of Allergy and Infectious Diseases reviewed the study data, and recommended that those in the group on Trizivir alone should be switched to other treatment regimens because the treatment failed for nearly one in four people.

"The key information here," said Dr. Joseph Hoagbin, deputy director of the HIV Clinic at the University of Nebraska Medical Center in Omaha, "is while this is a simple regimen with few side effects, it is not effective. It is not potent enough to maintain long-term viral suppression."

Dr. Charles Gonzalez, an investigator at New York University's AIDS Clinical Trial Center, agreed. "This is a beautifully done study that put the nail in the coffin for what was intended to be a regimen with less long-term complications. This combination is not worth the risk."

The biggest surprise in this study, he said, was that people were just as likely to do poorly on this regimen whether they had a high viral load or a low one.

Gulick says the study is continuing until the end of 2004 with the remaining participants on the other two drug combinations.

"This study really tells us the importance of head-to-head comparisons of drug regimens," said Gulick, because previous data suggested these combinations were all good treatment options.

Fortunately, added Hoagbin, there are other simple treatment options available now. And, he said, the most important thing people with HIV need to know is that it's important to keep the disease under control as quickly as possible.

"If you don't get control early, it's very difficult to gain control later," he said.

More information

For more information on HIV treatment, go to the National Institutes of Health, while the U.S. Centers for Disease Control and Prevention has this guide to living with HIV/AIDS.

SOURCES: Roy Gulick, M.D., director, Cornell HIV Clinical Trials Unit, New York-Presbyterian/Weill Cornell Medical Center, New York City; Charles Gonzalez, M.D., assistant professor, medicine, New York University School of Medicine, and investigator, New York University Medical Center's AIDS Clinical Trial Center, New York City; Joseph Hoagbin, M.D., assistant professor, medicine, and deputy director, HIV clinic, University of Nebraska Medical Center, Omaha; April 29, 2004, New England Journal of Medicine
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