Improvement of lipids following switch to tenofovir

Switching patients with virologically controlled HIV infection to a simplified maintenance ARV regimen results in an improved lipid profile, according to the preliminary findings of a French randomised, multicentre trial of 143 patients.

Despite low lipid levels at baseline, switching to a tenofovir (Viread) based combination can mildly decrease total and LDL-cholesterol and significantly reduce triglycerides, according to Mercié and colleagues. They assessed the benefits of switching patients who had been on NNRTI- or PI-based HAART for >6 months and had viral load (VL) <50 copies/mL to either efavirenz+tenofovir or efavirenz+tenofovir+3TC.

Mean age was 42 +/-10 years, 72% men and 28% women. Mean HAART duration at baseline was 3.7+/-1.9 years.

Median total and LDL cholesterol reduced from 5.3 mmol/l and 3.4 mmol/l by -0.4 and -0.3 respectively, both NS (p~0.20); HDL did not change. Median triglycerides reduced from 1.4 mmol/l at baseline by -0.4 (p<0.004).

There were four serious adverse events (suicide attempt, pneumonia, dizziness and hepatic cytolysis), with two discontinuations. Only one patient had VL>50 copies/ml (69 copies/ml at week 48). CD4 count increased by +23 (median CD4+ of 475/mm3 at baseline).

Comment

Although these results have generated interest related to the dual therapy maintenance arm it is unclear why this 48-week study merited an interim analysis and presentation at 36 weeks. The study continues and final results including lipodystrophy (evaluated by DEXA and CT) will be reported in 2005.

Mercié P, Trylesinski A, Cabié A et al. Improvement in lipid profile in HIV-infected virologically controlled patients switched to a simple QD regimen: Preliminary results of the COOL trial evaluating EFV/TDF vs EFV/TDF/3TC. 6th Lipodystrophy Workshop (6th IWADRLH), Washington, 2004. Abstract 82. Antiviral Therapy 2004; 9:L48.
http://www.aegis.org/DisaplayConf/?Abstract=87204