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Continuation of BID boosted PI vs switch to once-daily ATV/RTV for the management of lipodystrophy: 48 week primary analysis of the 96 week multicenter, open-label, randomized, prospective ReAL study
Presented by Graeme Moyle, United Kingdom.
G. Moyle1, J.-M. Girard2, J. Andrade3, P. Salvato4, J. Bogner5, P. Hay6, I. Santos7, L. Astier8, M. Pans8, S. Biguenet9, A. Antinori10, The ReAL Study Group
1Chelsea And Westminster Hospital, London, United Kingdom, 2Saint-Antoine Hospital, Paris, France, 3Hosp. Civil De Gdj, Mexico, Mexico, 4Diversified Medical Practices PA, Houston, United States, 5Medizinische Klinik Der LMU, Munich, Germany, 6St.George's Hospital, London, United Kingdom, 7Hospital de la Princesa, Madrid, Spain, 8Bristol-Myers Squibb Research and Development, Braine L'Alleud, Belgium, 9Bristol-Myers Squibb Research and Development, Rueil-Malmaison, France, 10Istituto Malattie Infettive I.R.C.C.S, Roma, Italy
Background: Atazanavir (ATV) is a potent, well-tolerated once-daily PI extensively studied in naïve and experienced patients. Comparative data have demonstrated similar efficacy with a superior lipid profile vs LPV/RTV. The ReAL Study evaluates the impact on body composition of switching from any BID boosted PI (PI/RTV) to a QD ATV/RTV-containing regimen in patients with lipohypertrophy.
Methods: Patients with waist circumference >90 cm and viral load <400 copies/mL were randomized (2:1) to ATV/RTV versus continuing PI/RTV. CT was used to quantify visceral, subcutaneous, and total adipose tissue (VAT, SAT, and TAT); DEXA was used to assess trunk and limb fat. Primary endpoint: changes in trunk-to-limb fat ratio by DEXA at 48 weeks.
Results: 201 patients were randomized (200 treated, 131 ATV/RTV, 69 PI/RTV [72% LPV/RTV]). At week 48, there was no significant difference between regimens in mean percent change from baseline in trunk-to-limb fat ratio (0.02 vs -0.02 for ATV/RTV and PI/RTV respectively) and in mean change from baseline in VAT, SAT, TAT, VAT-to-TAT and VAT-to-SAT. Viral rebound rates were similar (³50 copies/mL: 5% vs 6% for ATV/RTV and PI/RTV respectively). Mean change from baseline CD4 (ATV/RTV vs PI/RTV) was 14.5 vs 44 cells/mm3. Mean percent changes from baseline in fasting lipids (ATV/RTV vs PI/RTV) were: Tot Chol -13% vs -1% (P<0.0001); HDL-Chol -6.2% vs -2.6% (P=0.22); LDL-Chol -10.4% vs 2.6% (P=0.0086); triglycerides -23.8% vs -11.7% (P=0.04); Non-HDL-Chol -14.8% vs -0.6% (P<0.0001). Discontinuation rates were (ATV/RTV vs PI/RTV) 8% vs 10%. Overall AES were comparable on both ATV/RTV and PI/RTV.
Conclusions: In this 48 week analysis, a switch from BID boosted PI to QD boosted ATV in patients experiencing lipohypertrophy resulted in no significant change in body composition with maintenance of efficacy and significant reduction in Tot-Chol, LDL-Chol and Non-HDL-Chol. Follow-up though week 96 is planned.