Important note: Information in this article was accurate in December 2004. The state of the art may have changed since the publication date.
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HIV Treatment Bulletin - Vol. 6, No. 1, December 2004 / January 2005
Graham McKerrow, HIV i-Base
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.
Ref: 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. Antiviral Therapy 2004; 9:L48 Abstract 82.
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