Table 3 Trials on the therapeutic switch to a NNRTI-containing regimen

LIPNEFA

(a subset of NEFA)

A subset (n. 90) of virologically suppressed HIV-infected patients enrolled in the NEFA study [98] enrolled in the NEFA study were analyzed for the HDL-C and LDL-C levels in the metabolic and body-composition substudy LIPNEFA .

HDL-C and LDL-C levels

24

At 24 months, efavirenz (EFV) and nevirapine (NVP) produced similar lipid benefits: HDL-C levels increased [EFV, 15% (p = 0.001); NVP, 21% (p < 0.001)] and TC to HDL-C ratios decreased [EFV, 14% (p < 0.001); NVP, 19% (p < 0.01)].

SPIRIT

Virologically suppressed HIV-infected adults who were receiving a PI-based HAART were switched to emtricitabine-rilpivirine-tenofovir difumarate (FTC-RPV-TDF).

TC, LDL-C, TGL, and TC:HDL-C ratio.

24

At 24 weeks, levels of TC, LDL-C, TGL, and the TC:HDL-C ratio had improved significantly in patients switched to FTC-RPV-TDF compared to those patients who kept their original PI-based treatment (p < 0.001). Nevertheless, HDL-C levels declined significantly less with the PI-based regimen (p < 0.001).

Study 111

Virologically suppressed patients who were switched from EFV-TDF- FTC to RPV-TDF-FTC.

Fasting TC, LDL-C, HDL-C, TGL, and TC:HDL-C ratio.

12, 48

A significative decline in fasting TC, LDL-C and TGL at 12 weeks into the protocol. Results at week 48 remained in the same direction (p = 0.016), although changes from baseline in HDL-C and the TC:HDL-C ratio were not significant. The introduction of RPV in the clinical arena has been very positive for the patients care, but we all have to remember the risk of a prolongation of QT interval with higher doses of this compound (i.e. 75 and 300 mg QD) as seen in the early phases of clinical development.

Etraswitch

The switch from a PI-containing regimen to etravirine (ETR) in patients with therapeutic success.

Glycemia, fasting TC, LDL-C, HDL-C, TGL, and TC:HDL-C ratio.

24

The group of patients who received ETR showed a significant reduction in TC (p < 0.001), TGL (p < 0.001), and glycemia (p = 0.03). The 2 groups differed significantly in TGL and glycemia at week 24. The greatest improvement in all lipids was seen in patients who switched from lopinavir/ritonavir to ETR.

na

A prospective, open-label, 12-week study of HIV-infected patients receiving either a on bPI or EFV, and statin treatment. Four weeks after statin interruption, bPI or EFV was switched to ETR (400 mg for 8 weeks) if serum low-density lipoprotein cholesterol (LDL-C) was ≥3 mM. The primary endpoint was the proportion of patients not qualifying for statin treatment 8 weeks after the ETR switch.

Fasting TC, LDL-C, HDL-C, TGL, and TC:HDL-C ratio.

12

After 8 weeks of ETR treatment, 15 patients (56%) on ETR did not qualify for statin treatment. After the ETR switch, serum levels of the cardiovascular biomarkers sICAM and MCP1/CCL2 decreased by 11.2% and 18.9%, respectively, and those of CCL5/RANTES and tissue inhibitor of metalloproteinase-1 increased by 14.3% and 13.4%, respectively, indicating reduced cardiovascular risk.