Abstract

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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

Presented by François Raffi, France.

Raffi F.¹, Ward D.², Ruxrungtham K.³, Brunetta J.⁴, Schutz M.⁵

¹University Hospital, Nantes, France, ²Dupont Circle Physicians Group, Washington DC, United States, ³HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand, ⁴Maple Leaf Medical Clinic, Toronto, Canada, ⁵Roche, Nutley, United States

Objectives: This prospective, multi-national, open-label study 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 £350 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. The efficacy analysis assesses the non-inferiority of SQV/r compared with LPV/r at 48 weeks. This planned interim analysis includes all patients completing 24 weeks of treatment.
Results: The majority of the patients were men (79.2%), with a racial distribution of 46.6% Caucasian, 32.6% black, 19.9% Asian and 0.9% other. Median (range) baseline viral load was 5.2 (4–7) vs 5.2 (4–7) log₁₀ HIV RNA c/mL and the median CD4 (range) was 137 (2–509) vs 138 (1–583) cells/mm³ for SQV/r vs LPV/r, respectively. Baseline HIV-1 RNA viral load was >100,000 c/mL in 67.5% vs 63.7% of SQV/r and LPV/r patients, respectively. Table 1.

	VL <400 c/mL, % of patients	VL <50 c/mL, % of patients	Median HIV RNA D log₁₀ c/mL (range)	Median CD4 D cells/mm³
SQV/r	75.9	64.5	-3.4 (-4.5–0.6)	126.0
LPV/r	74.9	64.3	-3.5 (-4.8–0.8)	132.5

Virologic failure was defined as any 2 consecutive HIV-1 RNA measurements, taken ³14 days apart, >400 c/mL, at ³16 weeks. Twenty-five patients discontinued SQV/r (6 AEs, 19 non-safety, including 10 virologic failures) vs 24 who discontinued LPV/r (11 AEs, 13 non-safety, including 3 virologic failures). Patients in the SQV/r-containing arm experienced less of an effect on lipids vs LPV/r.
Conclusions: In this 24-week interim analysis, SQV/r appeared to be comparable with LPV/r in terms of tolerability and virologic and immunologic efficacy. Non-inferiority of the regimen will be evaluated in the final 48-week analysis.

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