3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

TMC114/R OUTPERFORMS INVESTIGATOR-SELECTED PI(S) IN 3-CLASS-EXPERIENCED PATIENTS: WEEK 24 PRIMARY ANALYSIS OF POWER 1 (TMC114-C213)

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeOaLB0102

Katlama C.¹, Carvalho M.T.², Cooper D.³, De Backer K.⁴, Lefebvre E.⁴, Pedro R.², Rombouts K.⁴, Stoehr A.⁵, Vangeneugden T.⁴, Woehrmann A.^6
1Hopital Pitie-Salpetriere, Paris, France, ²Hospital de Clinicas-UFPR, Curitiba, Brazil, ³University of New South Wales, Sydney, Australia, ⁴Tibotec BVBA, Mechelen, Belgium, ⁵IFI-Institut im AK St. Georg, Hamburg, Germany, ⁶University of Cologne, Cologne, Germany

INTRODUCTION: To determine the efficacy of TMC114/ritonavir (TMC114/r) in 3-class-experienced patients in a randomized, controlled, international, multi-center phase IIb efficacy/safety trial.

METHODS: Three-class-experienced patients on a stable PI-regimen with VL >1,000 copies/mL were randomized to one of four TMC114/r doses, or investigator-selected PI(s). Patients received OBR (>2 NRTIs with/without enfuvirtide [ENF]). All patients had >1 primary PI mutation. All analyses were intent-to-treat.

RESULTS: Patients (n=318) had received a mean of 4 prior Pis. Baseline values were comparable across all groups: mean VL was 4.48 log₁₀ copies/mL and CD4 was 179 cells/mm³; 13%, 31% and 56%, respectively had 1, 2 or >3 primary PI mutations. OBR contained >1 active NRTI(s) in 79% of all patients. During study, 10% of TMC114/r patients discontinued vs 62% of controls (control discontinuations mainly occurred for virological failure). Efficacy data are presented for the TMC114/r dose selected for treatment-experienced patients (600mg/100mg bid, n=65, vs controls n=63). At Week 24, the mean CD4 increase from baseline was 124 cells/mm³ for TMC114/r vs. 20 cells/mm³ for control (p<0.001). The primary endpoint of >1 log₁₀ VL reduction from baseline was achieved in 77% of TMC114/r patients vs. 25% for control (p<0.001). Mean VL decrease for TMC114/r was 2.03 vs. 0.63 log₁₀ copies/mL for control (p<0.001). VL <50 copies/mL occurred in 53% of TMC114/r patients vs. 18% of controls (p<0.001). VL <50 copies/mL was achieved in 63% of the 19 TMC114/r patients who received ENF in their OBR (previously ENF-naïve), vs 56% of the 34 TMC114/r patients who did not receive ENF.

CONCLUSIONS: The magnitude of viral suppression achieved with TMC114/r in 3-class-experienced patients was significantly greater than control PI(s) and similar to that seen in less experienced patients. An exceptional CD4 response was observed.

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