Abstract 668 - An Open Randomized Study on the Replacement of HIV-1 Protease Inhibitors by Efavirenz in Chronically Suppressed HIV-1-Infected Patients with Lipodystrophy.

668 An Open Randomized Study on the Replacement of HIV-1 Protease Inhibitors by Efavirenz in Chronically Suppressed HIV-1-Infected Patients with Lipodystrophy.

E. Martinez, J. Romeu, M. A. Garcia-Viejo, L. Cruz, J. L. Blanco, E. Negredo, B. Clotet, and J. M. Gatell.
Hosp. Clín., Barcelona and Hosp. Germans Trías i Pujol, Badalona, Spain.

Background:Though the replacement of HIV-1 protease inhibitors (PI) in patients with lipodystrophy has been usually associated with improvement of metabolic abnormalities, conflicting results have been reported with efavirenz in the few non-randomized existing studies.

Methods:HIV-1-infected adults treated with PI-containing HAART with <200 copies/mL for at least the previous 6 months and body changes consistent with body fat accumulation and/or depletion were randomized to continue on PIs or to replace them by efavirenz. Body fat changes in 7 regions (dorsocervical, breasts, abdominal, face, buttocks, and upper and lower extremities) were quantified by the patients according to their perception of severity. CD4 cells, plasma viral load, and fasting glucose, triglycerides, cholesterol, and insulin, as well as measurement of regional fat by sonography, were performed at baseline and every 3 months thereafter until 1 year of follow-up.

Results:93 patients (46 efavirenz, 47 PI) were included. Baseline characteristics were well matched between both groups. On comparing the results at 12 mo with those at baseline, patients on efavirenz had significant decreases in BMI, WHR, severity scores of abdominal, buttocks and extremities and significant increases in insulin sensitivity and HDL-cholesterol. Patients on PI had higher increases of intra-abdominal fat thickness on intra- and inter-group comparisons and higher decreases of subcutaneous fat in the extremities, although those assigned to efavirenz also had progressive decreases of subcutaneous fat. There was good correlation between subjective perception and objective sonographic measurement. Virological suppression was equally maintained in both groups. Adverse effects were more common in patients on efavirenz, but they were usually mild.

Conclusions:The replacement of PIs by efavirenz was safe and it seemed to slow the evolution of body fat changes, although there was a progression of lipoatrophy