An Interview with Josť M. Gatell, MD, PhD,
Senior Consultant & Head,
Infectious Diseases & AIDS Units of the Hospital Clinic
. Barcelona, Spain


September 25, 2003

 

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 Josť M. Gatell, MD, PhD.