Objective: To describe the 12-month evolution of lipid profile in HIV-infected virologically suppressed patients substituting tenofovir for stavudine.
Design and methods: 'Recover' was a prospective, multicenter, switch study conducted at 120 HIV units across Spain designed to identify single nucleoside analogue substitution due to adverse events in real practice. Tenofovir substituted stavudine in 873 adult patients. No other substitutions were allowed. This lipid sub-study included 352 randomly recruited patients with complete follow-up and lipid parameters.
Main outcome measures: Changes in fasting levels of total cholesterol (TC), high and low-density lipoprotein cholesterol (HDL-C and LDL-C), and triglycerides (TG) at 48 weeks, and their cardiovascular risk (CVR) translation.
Results: At 48 weeks, there was a sustained reduction in median TC (-17.5 mg/dl; P < 0.001), LDL-C (-8.1 mg/dl; P < 0.001), and TG (-35 mg/dl; P < 0.001). HDL-C remained roughly unchanged (-0.8 mg/dl). Patients with baseline hyperlipidaemia showed greater reductions in LDL-C (-29 mg/dl; P < 0.001) and TG (-76 mg/dl; P < 0.001). The greatest TG reduction was observed in patients with severe hyper-TG (-266 mg/dl; P < 0.001). The estimated 10-year CVR decreased in all patients (P < 0.001), and to a higher extent in patients with baseline hyperlipidaemia. There was a trend towards reduction according to the use of lipid-lowering agents (11.6% to 9,9%; P = non-significant).
Conclusions: The substitution of tenofovir for stavudine causes a sustained improvement of dyslipidaemia. The reduction, although modest, is robust and sustained over time, and significantly reduces the CVR. This switch strategy is safe and contributes to an improvement in the lipid profile, especially TG, in HAART-treated patients.