Impact of switching from zidovudine/lamivudine to tenofovir/emtricitabine on lipoatrophy: the RECOMB study

Objectives Lipoatrophy is a long‐term adverse effect of some antiretrovirals that affects quality of life, compromises adherence and may limit the clinical impact of HIV treatments. This paper explores the effect of tenofovir/emtricitabine ( TDF / FTC ) on the amount of limb fat in patients with virological suppression. Methods A randomized, prospective clinical trial was performed to compare continuation on a zidovudine/lamivudine ( ZDV/3TC )‐based regimen with switching to a TDF / FTC ‐based regimen in terms of the effect on limb fat mass as assessed by DEXA over a 72‐week period. Results Eighty patients were included (39 in the TDF / FTC arm and 41 in the ZDV /3 TC arm) and 73 completed the study (37 and 36, respectively). In the switch arm, limb fat increased by a median of 540 g from baseline ( P  = 0.022), while in the ZDV/3TC arm it decreased by a median of 379 g ( P  = 0.112; p between groups = 0.007). Subjects with baseline limb fat ≤ 7200 g, previous time on ZDV  > 5 years or a body mass index > 25 kg/m 2 experienced higher limb fat gains than other subjects, and these differences were statistically significant. Haemoglobin increased by a median of 1.0 g/d L in the TDF / FTC arm ( P  < 0.001) and remained unchanged in the ZDV/3TC arm (p between groups = 0.0002). There were no significant differences between groups in other secondary endpoints (body weight, total body and trunk fat content, total body bone mineral density, laboratory parameters, CD 4 cell count and viral load). Conclusions Switching from a ZDV/3TC ‐based to a TDF / FTC ‐based regimen led to a statistically significant improvement in limb fat, in contrast to the progressive loss of limb fat in subjects continuing ZDV/3TC .