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.