Simon Collins, HIV i-Base

Francois Raffi from University Hospital, Nantes, France, presented interim results (24 week) from the Gemini study, which randomised 337 treatment-naïve patients to twice daily regimen of SQV/r (1000mg/100mg BID) or standard dose lopinavir/r BID. [1]

Baseline viral load and CD4 count were balanced between each arm (approximate median (range) of 5.2 logs (4.0–7.0) and 137 cells/mm3 (1–580) respectively). Baseline viral load was >100,000 copies/mL in 67% – 63% patients.

Virological responses were similar with 89% and 69% patients in each arm suppressed to <400 and <50 copies/mL respectively. Virological failure occurred more frequently in the saquinavir arm (10/166, 6% vs 3/171, 1.8%) and new PI resistance was only reported in two patients in the saquinavir arm.

Lipid data, presented in a poster from Sharon Walmsley, showed that total cholesterol, LDL and HDL all increased by a similar amount in the SQV/r and LPV/r arms (by approximately +180, +100 and +45mg/dL respectively), with triglycerides increasing slightly less in the saquinavir arm (+129 vs +161 mg/dL). [2]

A higher percentage of patients using lopinavir/r had lipid changes that left them over NCEP guidelines for using lipid lowering drugs (1.2 vs 8.9% for cholesterol and 21.5 vs 26.8% for triglycerides).

As with previous presentations of this study, 48-week results are needed to know the clinical importance of these differences in a head-to-head study.

References

1. Raffi F, Ward D, Ruxrungtham K et al. Saquinavir/r (SQV/r) BID vs lopinavir/r (LPV/r) BID plus emtricitabine/tenofovir (FTC/TDF) QD as initial therapy in HIV-1 infected patients: the Gemini Study. 4th IAS Conference, Sydney, 2007. Abstract WEPEB027.
http://www.ias2007.org/pag/Abstracts.aspx?AID=4318
2. Walmsley S, Bredeek U, Avihingsanon A et al. 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. 4th IAS Conference, Sydney, 2007. Abstract TUPEB069.
http://www.ias2007.org/pag/Abstracts.aspx?AID=4617