SWITCHMRK 1 & 2 Trials Switching from Lopinavir-Ritonavir to - - PowerPoint PPT Presentation

Switching from Lopinavir-Ritonavir to Raltegravir

SWITCHMRK 1 & 2 Trials

Switching from Lopinavir-Ritonavir to Raltegravir

SWITCHMRK 1 & 2 Trials: Study Design

Source: Eron JJ, et al. Lancet. 2010;375:396-407.

Switch Arm

Raltegravir 400 mg BID

(n = 353)

Continuation Arm Lopinavir-ritonavir 400-100 mg BID

(n = 354)

Study Design: SWITCHMRK 1&2

• Background: Randomized, double-blind,

double-dummy trial evaluating switch from lopinavir-ritonavir to raltegravir in combination with background therapy.

• Inclusion Criteria (n = 707 combined)
• Age ≥18 years
• HIV RNA <50 copies/mL for ≥3 months
• On lopinavir-ritonavir
• CD4 count ≥100 cells/mm3
• No lipid-lowering agent for 12 weeks
• 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

Switching from Lopinavir-Ritonavir to Raltegravir

SWITCHMRK 1 & 2 Trials: Results

Week 24: Virologic Response (Non-Completion Counted as Failure)

Source: Eron JJ, et al. Lancet. 2010;375:396-407.

81 88 84 87 94 91

20 40 60 80 100

SWITCHMRK 1 SWITCHMRK 2 Combined Data

HIV RNA < 50 copies/mL (%)

Raltegravir Lopinavir-ritonavir

Virologic Failure: Lopinavir-Ritonavir (N = 4); Raltegravir (N = 12) 139/172 154/175 293/347 152174 167/178 319/352

Switching from Lopinavir-Ritonavir to Raltegravir

SWITCHMRK 1 & 2 Trials: Results

Week 24: Virologic Response (Non-Completion Counted as Failure)

Source: Eron JJ, et al. Lancet. 2010;375:396-407.

88 77 90 92

20 40 60 80 100

LPV-RTV Therapy as First Regimen Investigator Report

• f Prior ART Failure

HIV RNA < 50 copies/mL (%)

Raltegravir Lopinavir-ritonavir

112/128 85/111 117/130 113/123

Switching from Lopinavir-Ritonavir to Raltegravir

SWITCHMRK 1 Trial: Results

SWITCHMRK 1 Week 12: Analysis of Lipids

Source: Eron JJ, et al. Lancet. 2010;375:396-407.

• 12.8
• 41.5
• 2.4
• 0.90

0.7 3.6 2.1 0.8

• 50
• 40
• 30
• 20
• 10

10 20 Total Cholesterol Triglycerides LDL Cholesterol HDL Cholesterol

Mean Change from Baseline at Week 12 (%)

Raltegravir Lopinavir-Ritonavir

Switching from Lopinavir-Ritonavir to Raltegravir

SWITCHMRK 2 Trial: Results

SWITCHMRK 2 Week 12: Analysis of Lipids

Source: Eron JJ, et al. Lancet. 2010;375:396-407.

• 12.4
• 42.8

4.0

• 0.6

1.3 8.2 0.6

• 2.5
• 50
• 40
• 30
• 20
• 10

10 20 Total Cholesterol Triglycerides LDL Cholesterol HDL Cholesterol Mean Change from Baseline at Week 12 (%)

Raltegravir Lopinavir-ritonavir

Switching from Lopinavir-Ritonavir to Raltegravir

SWITCHMRK 1 & 2 Trials: Conclusions

Source: Eron JJ, et al. Lancet. 2010;375:396-407.

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.”

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.