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Abstract
Nevirapine can limit efavirenz-associated severe dyslipidemia: a randomized controlled study
Parienti J.-J.1, Massari V.2, Rey D.3, Poubeau P.4, Verdon R.1, for the SIROCCO study group
Objectives: Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The impact of substituting nevirapine (NVP) in patients with severe EFV-associated dyslipidemia is unknown
Methods: A Phase IV, open-label, parallel group, active control, randomized 52 week trial in seven outpatients HIV clinics in France. The primary outcome was centralized fasting Low Density Lipoprotein cholesterol (LDL-c) change between baseline and week 52 in EFV-treated patients with HIV RNA<400 cp/ml and no prior therapy with NVP. Secondary endpoints were other lipids change and dose effect between NVP and EFV centralized plasma levels at week 12 and LDL-c at week 52.
Results: Thirty seven patients were enrolled with a baseline LDL-c of 4.4 (+/-1.3) mmol/L after a mean exposure to EFV of 41 months [range: 7 to 80]. Among the 34 randomized patients with primary outcome, mean LDL cholesterol significantly decreased from baseline in the NVP-switch arm (n=17) but not in the EFV-continuation arm (n=17): mean change was –0.43 mmol/L [95% confidence interval for difference; -0.81 to -0.05] versus –0.09 mmol/L [-0.40 to 0.22], respectively. NVP switch versus EFV continuation (p<0.04) was associated with one year LDL-c decrease, adjusting for receiving abacavir or tenofovir (p=0.04), sex (p=0.23) and physical activity (p=0.12).
[NVP and LDL-c relationship]
Strong linear dose-effect relationship (R2=0.45, p<0.001) was found between NVP level and LDL-c (Figure) but not with EFV levels. Switching to NVP had no significant effect on other lipids secondary endpoints.
Conclusions: Switching to NVP in patients with EFV-associated dyslipidemia demonstrates a 52 weeks reduction in LDL-c levels beyond EFV continuation.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
CDB314
Suggested Citation
"ParientiJ.-J., et al.
Nevirapine can limit efavirenz-associated severe dyslipidemia: a randomized controlled study.
:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
CDB314"
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