Medical Advocates: The publication of
Substitution of Nevirapine, Efavirenz, or Abacavir for Protease
Inhibitors in Patients with Human Immunodeficiency Virus Infection.
in the September 11 [2003] New England Journal of Medicine has been
widely discussed by many physicians here in the United States.
Unfortunately, there are many physicians who often do not have immediate
access to the journal and who would welcome knowing more about this study in
which you were one of the investigators. Please explain the purpose of the
NEFA
[Nevirapine/Efavirenz/Abacavir]
trial described in this article?
Dr Gatell: To test if switching from a PI containing regimen in
patients with plasma viral load below 200 copies to Abacavir, nevirapine or
efavirenz is feasible and to perform a head to head comparison of these 3
drugs.
Medical Advocates: What were the main
study findings?
Dr Gatell: At one year approximately 90% remain undetectable. Rate of
virological failure was higher in the abacavir arm but toxicity was higher
in the nevirapine and
efavirenz arms. Consequently in
the on-treatment analysis abacavir was inferior to nevirapine or efavirenz
but in the intent-to-treat analysis (NC=failure, not reported in the paper)
all 3 arms were equivalent. Most of the virological failures in the abacavir
arm occurred in patients with previous suboptimal therapies with one or two
nucleosides in the past. Lipid profile improved mostly in the
abacavir arm
Medical Advocates: What is the
significance of these results for HIV patients?
Dr Gatell: A PI-containing regimen in
responding patients can be replaced by a more simple regimen, with some
advantages, mostly in patients without prior suboptimal therapies or
previous virological failures
Medical Advocates: What were the
efficacy and safety results between nevirapine and efavirenz?
Dr Gatell: There was no statistically significant difference between
nevirapine and efavirenz. The percentage of patients discontinuing therapy
due to side effects was almost identical in both arms although the toxicity
profile was different.
Medical Advocates: What do these
results mean for physicians?
Dr Gatell: A substantial number of patients who are still receiving
complex PI-containing regimens can be simplified without losing efficacy.
Medical Advocates: What is the significance of this study for
patients currently on PI-containing regimens?
Dr Gatell: A substantial number of patients who are still receiving
complex PI-containing regimens can be simplified without losing efficacy.
Medical Advocates: How can you
as a physician relate the study findings back to your practice as you treat
HIV-infected patients?
Dr Gatell: Switching patients with undetectable viral load from a
PI-containing regimen to nevirapine, efavirenz or abacavir has already been
a relatively common practice, at least in Europe, during past years. These
study further supports the scientific rational for this practice. Moreover,
it is the first head-to-head comparison between nevirapine, efavirenz and
abacavir for this strategy. In patients without prior suboptimal therapies
with one or two nucleosides either of these three drugs can be used.
Conversely, nevirapine or efavirenz should be preferred when previously
suboptimal therapies did exist.
Medical Advocates: Thank you for your
time. Your comments will be very helpful to many physicians.
An
Interview
with José
M. Gatell, MD, PhD. |