Jornal de AIDS e Pesquisa Clínica

The objective of this study was to describe, in real-life settings, the patients treated by the HIV fusion inhibitor enfuvirtide and to evaluate efficacy and safety of this new antiretroviral drug in comparison with the results of the pivotal studies TORO 1 and TORO 2.

Adult HIV-1-infected patients, treated for the first time with enfuvirtide since less than 2 months, were eligible for the study. From September 2004 to May 2006, 364 patients (male, 81%) with a mean (SD) age of 45 (9) years and at CDC stage C for 52% of them were included and followed for 2 years. The median duration of antiretroviral treatment was 10 years with a median number of 11 drugs. Median HIV viral load was 4.7 log 10 copies/mL and median CD4 cell count was 155 cells/mm 3 (respectively, 5.2 log 10 copies/mL and 89 cells/mm 3 in TORO studies). Compared to the TORO studies, the proportion of patients on enfuvirtide treatment with HIV RNA < 400 copies/mL in ZOOM study was higher (61 vs. 34% at 1 year; 77 vs. 48% at 2 years). The immunologic benefit was approximately the same at 2 years (+173 cells/mm 3 in ZOOM vs. +166 cells/mm 3 in TORO studies). Bacterial pneumonia was reported for 5 patients (0.81 case for 100 patient-years).

In conclusion, in real-life settings, the results of the ZOOM study at 2 years confirmed the virologic and immunologic benefits and the favorable safety of enfuvirtide reported in the TORO pivotal trials.