LBPE17 - Poster Exhibition
Non-inferiority of dual-therapy (DT) with lopinavir/ritonavir (LPV/r) plus lamivudine (3TC) vs. triple-therapy (TT) with LPV/r plus two nucleos(t)ides (NRTIs) for maintenance of HIV viral suppression: 48-week results of OLE study
J.M. Gatell1, J.R. Arribas2, P.M. Girard3, R. Landman4, J. Pich1, J. Mallolas1, M. Martínez1, J.F. Zamora2, V. Estrada5, M. Crespo6, D. Podzamczer7, J. Portilla8, F. Dronda9, J.A. Iribarren10, P. Domingo11, F. Pulido12, M. Montero13, H. Knobel14, A. Cabié15, L. Weiss16, OLE Study Group
1Hospital Clinic. University of Barcelona, Barcelona, Spain, 2Hospital La Paz, Madrid, Spain, 3Hospital St Antoine, Paris, France, 4Hospital Bichat Claude Bernard, Paris, France, 5Hospital Clínico San Carlos, Madrid, Spain, 6Hospital Vall d'Hebrón, Barcelona, Spain, 7Hospital Universitario de Bellvitge, Barcelona, Spain, 8Hospital General Universitario de Alicante, Alicante, Spain, 9Hospital Universitario Ramón y Cajal, Madrid, Spain, 10Hospital de Donostia, Donostia, Spain, 11Hospital de Sant Pau, Barcelona, Spain, 12Hospital 12 de Octubre, Madrid, Spain, 13Hospital La Fe, Valencia, Spain, 14Hospital del Mar, Barcelona, Spain, 15Hospital La Meynard, Martinique, France, 16Hospital Europeen Georges-Pompidou, Paris, France
Background: DT with LPV/r plus 3TC may be as effective, better tolerated and substantially less costly than TT with LPV/r 2 N(t)RTIs for maintenance of viral suppression.
Methods: OLE is a 48-week multicenter, open-label, non-inferiority trial (margin -12%) in which HIV-infected patients with < 50 copies/mL for ≥6 months on TT with LPV/r plus 3TC or FTC plus a third nucleos(t)ide, with no resistance to LPV/r or 3TC/FTC were randomized (1:1) to continue TT or switch to DT with LPV/r and 3TC both bid. Primary endpoint was therapeutic failure (= 2 consecutive viral loads > 50 copies/mL or death, AIDS-defining event, loss to follow up or change/interruption of randomized therapy in the modified-ITT population ,excluding major protocol violations and never exposed patients) at 48 weeks. Secondary endpoints were protocol defined virological failure (>50 copies/mL, confirmed), any episode of detectable viral load and overall tolerability at 48 week.
Results: 250 patients were randomized to continue TT (n=127. 58% with TDF/FTC, 28% with ABC/3TC) or to switch to DT (n =123). Baseline characteristics including prior cART exposure and known virological failures were balanced between arms. Proportion of patients free of therapeutic failure (TT vs DT): In the m-ITT population: 90.9 % (110/121) vs 91.5% (108/118), difference -0.61; 95% CI -6.9% to 8.1%; in the ITT population: 86.6% (110/127) vs 87.8% (108/123), difference -1.19 (95% CI -7,29 to 9,61). 3 patients per arm developed protocol-defined virological failure. Proportion of patients without any episode of detectable viral load (m-ITT) was 87.6% and 87.3% in TT and DT respectively (difference 0.3%; 95% CI -8.9% to 8.3%). Switching to DT was not associated with significant changes in lipid fractions and creatinine relative to continuing TT. Serious adverse events and study drug discontinuations due to adverse events occurred in 6.6% and 3.3% in TT and in 4.2% and 0.8% of patients in DT (P=NS).
Conclusions: DT with LPV/r plus 3TC has shown non-inferiority and was as well tolerated as LPV/r plus two NRTIs for maintenance of viral suppression. DT has the added benefit of preserving options and reducing the cost.
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