Switching from Lopinavir-Ritonavir to Raltegravir SWITCHMRK 1 & 2 Trials
Switching from Lopinavir-Ritonavir to Raltegravir SWITCHMRK 1 & 2 Trials: Study Design Study Design: SWITCHMRK 1&2 • Background : Randomized, double-blind, double-dummy trial evaluating switch from Switch Arm lopinavir-ritonavir to raltegravir in combination Raltegravir 400 mg BID with background therapy. (n = 353) • Inclusion Criteria (n = 707 combined) - Age ≥18 years - HIV RNA <50 copies/mL for ≥ 3 months - On lopinavir-ritonavir Continuation Arm - CD4 count ≥ 100 cells/mm 3 - No lipid-lowering agent for 12 weeks Lopinavir-ritonavir 400-100 mg BID (n = 354) • Treatment Arms* - Raltegravir 400 mg BID + background therapy - Lopinavir-ritonavir 400-100 mg BID + background therapy *Background therapy in both groups included at least 2 NRTIs Source: Eron JJ, et al. Lancet. 2010;375:396-407.
Switching from Lopinavir-Ritonavir to Raltegravir SWITCHMRK 1 & 2 Trials: Results Week 24: Virologic Response (Non-Completion Counted as Failure) Raltegravir Lopinavir-ritonavir 100 HIV RNA < 50 copies/mL (%) 94 91 88 87 80 84 81 60 40 20 139/172 152174 154/175 167/178 293/347 319/352 0 SWITCHMRK 1 SWITCHMRK 2 Combined Data Virologic Failure: Lopinavir-Ritonavir (N = 4); Raltegravir (N = 12) Source: Eron JJ, et al. Lancet. 2010;375:396-407.
Switching from Lopinavir-Ritonavir to Raltegravir SWITCHMRK 1 & 2 Trials: Results Week 24: Virologic Response (Non-Completion Counted as Failure) Raltegravir Lopinavir-ritonavir 100 HIV RNA < 50 copies/mL (%) 92 90 88 80 77 60 40 20 112/128 117/130 85/111 113/123 0 LPV-RTV Therapy Investigator Report as First Regimen of Prior ART Failure Source: Eron JJ, et al. Lancet. 2010;375:396-407.
Switching from Lopinavir-Ritonavir to Raltegravir SWITCHMRK 1 Trial: Results SWITCHMRK 1 Week 12: Analysis of Lipids Raltegravir Lopinavir-Ritonavir 20 10 Mean Change from Baseline 3.6 2.1 0.7 0.8 0 at Week 12 (%) -0.90 -2.4 -10 -12.8 -20 -30 -40 -41.5 -50 Total Cholesterol Triglycerides LDL Cholesterol HDL Cholesterol Source: Eron JJ, et al. Lancet. 2010;375:396-407.
Switching from Lopinavir-Ritonavir to Raltegravir SWITCHMRK 2 Trial: Results SWITCHMRK 2 Week 12: Analysis of Lipids Raltegravir Lopinavir-ritonavir 20 Mean Change from Baseline 8.2 10 4.0 1.3 0.6 at Week 12 (%) 0 -0.6 -2.5 -10 -12.4 -20 -30 -40 -42.8 -50 Total Cholesterol Triglycerides LDL Cholesterol HDL Cholesterol Source: Eron JJ, et al. Lancet. 2010;375:396-407.
Switching from Lopinavir-Ritonavir to Raltegravir SWITCHMRK 1 & 2 Trials: Conclusions Interpretation : “Although switching to raltegravir was associated with greater reductions in serum lipid concentrations than was continuation of lopinavir-ritonavir, efficacy results did not establish non-inferiority of raltegravir to lopinavir-ritonavir .” Source: Eron JJ, et al. Lancet. 2010;375:396-407.
Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $800,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program. The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.
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