Background: In contrast to what has been observed with most PI-based Antiretroviral Therapy (ART) regimens, nNRTI-based regimens have been reported to be associated with changes in plasma lipids of potential benefit with respect to the risk of developing cardiovascular disease (CVD). In this study we compared plasma lipid changes in patients enrolled in the 2NN trial.

Methods: A multi-centre, open label, randomised trial of 1,216 therapy naïve patients (pts) randomised to either NVP once daily (od) or twice daily (bd), Efavirenz (EFV), or Nevirapine (NVP) (od) +EFV. The NRTI backbone consisted of d4T and 3TC, which could be changed for toxicity reasons. Lipid samples were obtained after a mandatory ≥ 3 hr fast. Primary outcome: absolute change in plasma lipid concentrations adjusted for baseline value between start of treatment and wk 48. Differences were tested using Anova. The analysis is limited to pts maintaining randomised treatment for 48 wks.

Results: All changes in lipid parameters (mmol/L) within each of the treatment arms indicated in the Table were statistically significant, except where indicated as ! p > 0.05, # p > 0.1.

 

	NVP (od)	NVP (bd)	EFV	NVP + EFV
	n = 142	n = 275	n = 289	n = 127
triglycerides (TG)	0.20 !	0.05 #	0.37	0.45
total cholesterol (TC)	1.01	0.95	1.11	1.41
LDL-cholesterol (LDL-c)	0.56	0.54	0.70	0.80
HDL-cholesterol (HDL-c)	0.35	0.37	0.25	0.41
TC:HDL-c ratio	-0.32	-0.41	0.05 #	-0.20 !

 

! p > 0.05, # p > 0.1, all other p < 0.05

 

Significant rises in TC, LDL-c , but also HDL-c, were observed within each of the treatment arms. In the two NVP-only arms, the increases in HDL-c were significantly larger than in the EFV-only arm (p < 0.001 both comparisons). The decreases in TC:HDL-c ratio were likewise significantly larger in the NVP-only arms compared to the EFV-only arm (od: p < 0.004; bd: p < 0.001). Significant rises in TG were only observed in the arms including EFV. The changes in HDL-c and TC:HDL-c ratio remained statistically significant, after adjusting for baseline plasma HIV-1 RNA (pVL) and CD4 count, as well as changes in pVL and CD4 count over 48 wks.

Conclusions: The lipid profile in pts treated with regimens including NVP only were different from those in patients exposed to EFV only. A higher HDL-c together with a lower TC:HDL-c ratio, observed in pts receiving NVP but not EFV, in the general population would be associated with a decrease in CVD risk.