PATIENTS DO BETTER WITH FEWER PILLS

USA Today (Magazine) 1 Oct. '00

Based on an analysis of more than 3,000 patients involved in triple-drug combination trials to treat HIV infection, researchers at Duke University Medical Center, Durham, N.C., say that patients who take fewer pills tend to do better than those who have more complex medication regimens. They speculate the reason is that patients who take fewer pills are more likely to adhere to their medication regimen--and therefore receive the greatest benefits of the therapy--than those on complex regimens, who may find it more difficult to take multiple pills at different times during the day. The simplest of the regimens called for patients to take as few as four pills a day, while the more complex regimens involved 16 pills taken at different times--some with food, others on an empty stomach.

The researchers initially set out to perform an analysis of the effects of triple-drug combinations, examining the results of 22 different trials involving a total of 3,115 patients who were being treated for the first time with anti-retroviral agents. These drugs interfere with the genetic machinery within the virus that allows it to make copies of itself. The trials looked at the use of two nucleoside reverse transcriptase inhibitors (NRTI) in combination with one of the following class of agents: a protease inhibitor, a non-NRTI, or another NRTI. Thirteen drugs were represented in the trials--10 that have received FDA approval and three in Phase II clinical development.

The study showed that patients in all the trials did about the same after 48 weeks. "However, in a subsequent analysis, we examined the relationship between the number of pills patients took and success of that treatment," notes John Bartlett, director of clinical research, Duke University Center for AIDS Research. "Our results show that there is strong and statistically significant correlation between the number of pills and the success of the regimen."

In clinical trials for different anti-retroviral agents, the key marker of success is the number of copies of HIV genetic material (RNA) detectable in the blood. The number gives researchers an idea about how the virus is replicating. For the study, levels of less than 50 copies per milliliter of blood indicate that a medication has been successful.

"We found that about 75% of patients on the simplest regimens had less than 50 copies of HIV RNA in their blood," Bartlett indicates. "In comparison, only about 20% of patients with the most complex regimens had less than 50 copies." There are a number of prospective trials ongoing in which patients are being switched to more simple regimens to see if that has any effect on outcome.