Wednesday, 18 January 2006 00:00

New HIV Drug Regimen More Effective Than Existing Therapy

WEDNESDAY, Jan. 18 (HealthDay News) -- New research suggests that some HIV patients might be better off with a newer drug regimen than one that's been considered the gold standard for years.

The recently developed three-drug cocktail causes fewer side effects and appears to be easier for patients to tolerate, an international team of doctors report in the Jan. 19 issue of the New England Journal of Medicine.

The drugs -- tenofovir DF (Viread), emtricitabine (Emtriva) and efavirenz (Sustiva) -- are now available in just two pills (Sustiva plus a Viread-Emtriva combination called Truvada.) Soon, the three drugs may be combined into a single pill, the researchers said.

"This is the way we're going for patients with HIV (who are) starting therapy for the first time," said study author Dr. Joel Gallant, associate director of the AIDS Service at Johns Hopkins University School of Medicine. "It's becoming very easy and safe and effective."

The simplicity of the new treatment is in sharp contrast to the early days of powerful AIDS drugs in the mid 1990s. Some patients "were taking 12 to 24 pills a day with lots of food restrictions," Gallant said. "We've come a long way in 10 years."

In recent years, a combination of zidovudine and lamivudine (AZT and 3TC, combined together into Combivir) plus Sustiva became popular. Both the new and older drug regimens try to stop the AIDS virus from attacking cells in the body.

Gallant and his colleagues wanted to see if the newer combination was easier on patients.

With funding from Gilead Sciences, which manufactures Viread, Emtriva and Truvada, the researchers recruited 517 HIV patients from 67 sites in the United States and several European countries. The patients -- average age of 36, none of whom had been treated for their HIV infection -- were randomly assigned to either drug regimen.

After a year, the researchers found that 80 percent of those on the new combination had suppressed the amount of HIV in their blood to virtually undetectable levels. (The virus remained in their bodies, however, so they weren't cured.)

For the older regimen, the number was 70 percent of patients.

Patients taking the new drug combination were also less likely to stop taking the medications because of side effects -- 4 percent, compared to 9 percent who took the older regimen.

In a subgroup of 100 patients, those on the new regimen were less likely to suffer from loss of fat, a potentially disfiguring side effect of AIDS treatment.

The cost of the Viread-Emtriva-Sustiva therapy is about $12,000 a year, similar to the older regimen, Gallant said.

Gallant discounted any suspicions that the study results might be biased because of Gilead's funding.

"I don't think anybody will be concerned about that," he said. "So many major studies are funded by drug companies. There aren't a whole lot of other sources of funding for that kind of study."

The study is expected to continue for another two years, the researchers said.

The findings are good news because they validate a larger number of treatment options, said Dr. Michael Horberg, director of HIV/AIDS policy with the Kaiser Permanente Health Plan. The smaller number of pills in the new regimen is another plus, he noted.

"We know that fewer numbers of pills a day is always going to lead to increased adherence," Horberg said, adding that fewer side effects will also help patients stick with their drug regimens.

But the new drug combination isn't for everyone, he said, especially those who aren't being treated for the first time.

Patients who are doing fine with their current drugs may have no reason to try different medicines, Horberg said. "They should not be thinking about rushing to their doctor with the paper