Once-A-Day Pill May Work As Well as Drug Cocktail to Control AIDS

People who have to take anti-AIDS medications several times a day to keep HIV levels in check may find a new treatment easier to swallow, researchers report.

In a preliminary study, a once-a-day boosted protease inhibitor appeared to work just as well as the standard three-drug cocktails used to control HIV infection.

Fewer pills often translates to less toxicity and lower costs, says researcher Susan Swindells, MBBS, of the University of Nebraska Medical Center in Omaha.

Using the simplified regimen also means there are more options if the drugs stop working, she tells WebMD.

The findings, presented here at a media briefing to kick off the International AIDS Conference, also appear in a special issue of The Journal of the American Medical Association.

First One-Pill-a-Day Drug for AIDS

Works for 91 Percent of Participants

The researchers studied 34 HIV-infected people who had been taking three different anti-AIDS medications for at least two years.

The drugs were working -- virus levels were undetectable in the blood -- but participants faced popping three or four pills twice a day for years.

For 24 weeks, all the participants switched to the simplified regimen, which consisted of the once-daily protease inhibitor Reyataz, plus the AIDS drug Norvir. Small doses of Norvir increase blood levels of protease inhibitors -- a phenomenon known as "boosting."

The new regimen continued to suppress the virus in 31 of the 34 (91 percent) participants.

And in all three patients for whom the therapy didn’t work, “there was a strong suggestion that they didn’t take their medication,” Swindells says.

Participants’ CD4 cell count, a measure of disease-fighting immune cells, also stayed stable. And no one stopped taking the drugs due to side effects.

More Than 1 Million Americans Living With HIV

Results Encouraging

Roy M. Gulick, MD, MPH director of the HIV Clinical Trial Unit at the New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, says that while preliminary, “the results suggest that for many patients, a boosted protease inhibitor will continue to suppress virus levels.

“If you’re asking people to take antiviral drugs for years, as is typically needed to control infection, you want to make the regimen as easy-to-take, as simple, and as non-toxic as possible,” Gulick says.

“One way to do that,” he says, “is to start with a multidrug regimen and get infection under control and then take some of the drugs away.”

The researchers stress that the simplified regimen may not be for everyone.

Prior to switching to boosted Reyataz, all the people in the study were in relatively good health, with HIV at undetectable levels in their blood.

The next step, the researchers say, is a larger, longer study in which half the people will continue taking the three-drug cocktails and the others will be given the simplified regimen.

Four Drugs No Better Than Three

Also at the briefing, Gulick reported that a four-drug cocktail isn't any better than the standard three-drug therapy at combating HIV in people with newly-diagnosed HIV infection.

In the study, 765 HIV-positive patients who had not previously taken anti-AIDS drugs were randomly assigned to one of two regimens: a four-drug cocktail consisting of Combivir (the AZT/Epivir combo drug), Ziagen, and Sustiva; or a three-drug cocktail containing Combivir and Sustiva.

After three years, HIV was undetectable in the blood of a similar number of patients in both groups: 88 percent in the four-drug group and 85 percent in the three-drug group.

By Charlene Laino, reviewed by Louise Chang, MD

SOURCES: XVI International AIDS Conference, Aug. 13-18, 2006, Toronto. Susan Swindells, MBBS, University of Nebraska Medical Center, Omaha. Roy M. Gulick, MD, MPH, director, HIV Clinical Trial Unit, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York City. The Journal of the American Medical Association, Aug.16, 2006, pp. 806-814, 769-781.