Background New therapies for HIV infection have brought great benefit to the patient. Protease inhibitors (PIs) are known to cause adverse effects on lipid profile and increase cardiovascular risk. Darunavir boosted with cobicistat (DRV/c) is a safe and effective alternative, providing a co-formulation of boosted DRV in a single tablet.

Purpose To evaluate variations in metabolic parameters to asess whether the lipid profile improves when a PI (ritonavir) is removed from the antiretroviral therapy (ART).

Material and methods This was a retrospective observational study of patients switching from ART to DRV/c (alone or combined), between 1 November 2015 and 30 June 2016. Blood test data, immediately prior to the change and subsequently (3 and 6 months), were recorded from 30 days after the switch. Demographics and metabolic parameters were collected: total cholesterol (TC), LDL cholesterol (LDLc), HDL cholesterol (HDLc), triglycerides (TG), creatinine (Cr) and glomerular filtration rate (GFR, CKD-EPI).

Results 193 patients switched from ART to DRV/c, 170 had a blood test of ≥30 days from the change. Mean age was 49.1 years, 65.9% men. Previous ART: 35% were on monotherapy: darunavir/ritonavir (DRV/r) or lopinavir/ritonavir (LPV/r), 16% had tenofovir (TDF). Most frequent combinations: DRV/r (31.2%), lamivudine (3TC)+DRV/r (19.4%), tenofovir/emtricitabine (TVD)+DRV/r (12.4%) and abacavir/lamivudine (KVX)+DRV/r (11.2%). No significant differences in baseline parameters, except TC by TDF (−19.6 mg/dL p=0.038). After the switch, 35% were on monotherapy (DRV/c), 13% with TDF. Most frequent combinations: DRV/c (34.7%), 3TC+DRV/c (26.5%), KVX+DRV/c (12.4%) and TVD+DRV/c (11.8%). After 5.8 months (n=48), changes in lipid profile were not significantly different from baseline, TC (+6.5 mg/dL p=0.04), cLDL (+11.8 mg/dL, p=0.11), cHDL (−2 mg/dL, p=0.09) and TG (−4.7 mg/dL, p=0.7). However, elevation of Cr persisted (+0.09 mg/dL, p<0.0001) and GFR (−8.9 mL/min, p<0.0001). In the subgroup of patients who stopped TDF (n=7), differences were higher: TC (+30.9 mg/dL p=0.001), cLDL (+22 mg/dL, p=0.004) and cHDL (+12 mg/dL, p=0.02). No significant differences in Cr (+0.03 mg/dL) or GFR (-1.9 mL/min) were found.

Conclusion Although DRV/c was theoretically supposed to improve the lipid profile, it was not shown to have a relevant impact on lipid parameters in the prior 6 months after switching therapies. Metabolic parameters were elevated in patients who stopped TDF and therefore its lipid lowering effect. There was an increase in Cr that persisted over time but was not clinically relevant.

No conflict of interest