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Evaluation of the impact of highly active antiretroviral therapy (HAART) on lipid profiles – data from the 24-week interim analysis of the Gemini Study: saquinavir/r (SQV/r) BID vs lopinavir/r (LPV/r) BID plus emtricitabine/tenofovir (FTC/TDF) QD in ARV-naïve HIV-1-infected patients
Presented by Sharon Walmsley, Canada.
Walmsley S.1, Bredeek U.2, Avihingsanon A.3, Slim J.4, Guittari C.5
1University of Toronto, Medicine, Toronto, Canada, 2El Rio, Special Immunology Associates, Tucson, United States, 3HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand, 4St Michael's Medical Center, Newark, United States, 5Roche, Nutley, United States
Objectives: HAART is associated with varying lipid abnormalities, potentially increasing the long-term risk of cerebrovascular and cardiovascular disease. Comparisons of the lipid changes of different agents are best understood in randomized trials. Gemini is an ongoing, 48-week prospective, multinational, open-label study that assessed the efficacy and tolerability of SQV/r vs LPV/r plus FTC/TDF in 337 ARV-naïve patients.
Methods: Subjects with HIV RNA >10,000 c/mL and CD4 ³350 cells/mm3 were randomized to SQV/r 1000/100 mg BID (n =166) or LPV/r 400/100 mg BID (n=171) plus FTC/TDF 200/300 mg QD for 48 weeks. This subanalysis evaluates the lipid changes of the two regimens from 331 patients completing 24 weeks of therapy.
Results: Table 1. Change in lipid parameters over 24 weeks Table 2. Change in lipid grades of clinical relevance (footnote) (total cholesterol >200mg/dL, LDL >130mg/dL, TG >400mg/dL): Both regimens improved HDL levels and changes in higher grade total cholesterol were similar.
Conclusions: At 24 weeks, the mean increase of triglycerides is lower and fewer patients in the SQV/r arm experienced an increase in their lipid grades as evaluated by the NCEP (National Cholesterol Education Program) guidelines. The differences between arms need to be confirmed in the final 48-week analysis and should be considered in the context of other cardiac risk factors when choosing a treatment regimen.
| | SQV/r Mean values in mg/dl | LPV/r Mean values in mg/dl | | | TC | LDL | TG | TC | LDL | TG | | Baseline | 158 | 94 | 134 | 154 | 89 | 143 | | Change by Week 24 | +20 | +12 | +14 | +29 | +13 | +72 |
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