Body fat distribution in HIV-infected patients treated for 96 weeks with darunavir/ritonavir monotherapy versus darunavir/ritonavir plus nucleoside reverse transcriptase inhibitors: the MONOI-ANRS136 Substudy

Objectives The aim of the study was to evaluate fat tissue distribution in HIV-infected patients with suppressed viraemia treated with darunavir/ritonavir (darunavir/r) monotherapy versus darunavir/r triple therapy. Methods This study was a substudy of the randomized, multicentre, open-label MONOI-ANRS 136 trial. Body fat distribution and metabolic parameters were measured at baseline, week 48 and week 96. Results In total, 156 patients of the 225 initially enrolled in the MONOI trial participated in this study, 75 in the darunavir/r monotherapy arm and 81 in the darunavir/r triple-therapy arm. The median limb fat increase from baseline was +0.34?kg [interquartile range (IQR) 0.040 to +1.140?kg; P?<?0.001] at week 48 and +0.33?kg (IQR 0.14 to +1.26?kg; P?=?0.001) at week 96 in the monotherapy arm, while there was no change (0.02?kg; IQR 0.53 to +0.52?kg) at week 48 and then an increase of +0.23?kg (IQR 0.45 to +0.87?kg; P?=?0.046) at week 96 in the triple-therapy arm. The two arms differed significantly at week 48 (P?=?0.001) but not at week 96. The median increase in trunk fat was +0.73?kg (IQR 0.24 to +1.60?kg; P?<?0.001) and 0.60?kg (IQR 0.41 to +1.49?kg; P?=?0.03) at week 48 and +1.16?kg (IQR 0.17 to +2.75?kg; P?<?0.001) and +0.90?kg (IQR 0.51 to +2.34?kg; P?=?0.001) at week 96 in the monotherapy and triple-therapy arms, respectively, with no difference between arms. At week 96, the only biological change was a glucose level elevation in the monotherapy arm (median +4.0?mg/dL; IQR 4.0 to +7.0?mg/dL) compared with the triple-therapy arm (P?=?0.012). Conclusions Overall, body fat tissue increased in patients on darunavir/r monotherapy and triple therapy, with no difference between the arms over 96 weeks. The only difference found was a delayed increase in limb fat tissue in the triple-therapy arm compared with the monotherapy arm in the first year.