AEGiS-Glasgow [PL2.5] Saquinavir/r (SQV/r) BID vs lopinavir/r (LPV/r) BID plus emtricitabine/tenofovir (FTC/TDF) QD in ARV-nave HIV-1 infected patients: GEMINI Study

Eighth International Congress on Drug Therapy in HIV Infection

Glasgow, UK - 12-16 November 2006

[PL2.5] SAQUINAVIR/r (SQV/r) BID VS LOPINAVIR/r (LPV/r) BID PLUS EMTRICITABINE/TENOFOVIR (FTC/TDF) QD IN ARV-NAÏVE HIV-1 INFECTED PATIENTS: GEMINI STUDY

Int Cong Drug Therapy HIV 2006 Nov 12-16;8:Abstract No. PL2.5

J. Slim, A. Avihingsanon, K. Ruxrungtham, M. Schutz, S. Walmsley
St Michaels Medical Center, Newark, USA; HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand; Roche, Nutley, USA; Univ of Toronto, Toronto, Canada

PURPOSE OF THE STUDY: This prospective, multi-national, open-label study assesses the efficacy and tolerability of SQV/r vs LPV/r plus FTC/TDF in 310 ARV-naïve patients.

METHODS: Subjects with HIV RNA >10,000 c/mL and CD4 ≤350 cells/mm³ were randomized to SQV/r 1000/100 mg BID or LPV/r 400/100 mg BID plus FTC/TDF 200/300 mg QD for 48 wks. The efficacy analysis will assess non-inferiority of SQV/r to LPV/r. These results are from a predefined interim analysis of the first 150 randomized patients who completed Wk 24. As all patients have been randomized, the reporting of these results should have minimal impact on study recruitment or bias final outcome-assessments.

SUMMARY OF RESULTS: Mean baseline HIV RNA was 5.1±0.63 vs 5.2±0.60 log₁₀ c/mL and median CD4 (range) was 107 (2–378) vs 84 (2–362) cells/mm³ for SQV/r (n=74) vs LPV/r (n=76) respectively. Fourteen patients discontinued SQV/r (3 AEs, 11 non-safety) vs 13 LPV/r (4 AEs, 9 non-safety). There were no significant differences in Wk 24 efficacy measures.

	% Patients <400 c/mL ITT/OT	% Patients <50 c/mL ITT/OT	Mean HIV RNA Δ log₁₀ c/mL	Mean CD4 Δ cells/mm³
SQV/r	80.6/92.1	69.4/79.4	-3.2	279
LPV/r	83.6/95.3	75.3/85.9	-3.5	294

Baseline fasting lipid parameters were balanced; at Wk 24 total cholesterol ≥200 mg/dL: SQV/r 7.9% vs LPV/r 25% (P<0.01); triglycerides ≥400 mg/dL: SQV/r 0% vs LPV/r 9.4% (P<0.05). Cumulative adherence ≥80% measured by 4-day recall at each visit was similar for SQV/r (83%) and LPV/r (85%).

CONCLUSIONS: At Wk 24, SQV/r appears comparable to LPV/r in terms of efficacy and tolerability. Non-inferiority of the regimen and lipid differences will be evaluated in the final 48-wk analysis.

Plenary Session: Open Papers

2006-11-12
PL2.5

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