EASIER ANRS 138 Trial Switch from Enfuvirtide to Raltegravir in - - PowerPoint PPT Presentation

Switch from Enfuvirtide to Raltegravir with Multidrug-Resistant HIV

EASIER ANRS 138 Trial

Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV

EASIER ANRS 138: Study Design

Source: Gallien S, et al. J Antimicrob Chemother. 2011;66:2099-106.

Immediate Switch Arm Raltegravir 400 mg BID + Background Regimen

(n = 84)

Delayed Switch Arm Enfuvirtide x 24 weeks, then Raltegravir 400 mg BID + Background Regimen

(n = 84)

Study Design: EASIER ANRS 138

• Background: Open label, randomized trial

evaluating switching from enfuvirtide-based therapy to raltegravir-based therapy, in virologically suppressed patients with multidrug resistant HIV-1 infection.

• Inclusion Criteria (n = 170)
• Age ≥18 years
• HIV RNA <400 copies/mL for >3 months
• History of triple class failure (PI, NRTI, NNRTI)
• Integrase inhibitor naïve
• Treatment Arms
• Raltegravir 400 mg BID + background regimen
• Enfuvirtide + background regimen x 24 weeks,

then switch enfuvirtide to raltegravir 400 mg BID

Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV

EASIER ANRS 138: Results

Virologic Response (Intent-to-Treat Analysis, censoring missing data)

Source: Gallien S, et al. J Antimicrob Chemother. 2011;66:2099-106.

88 89 90 85 88 90 20 40 60 80 100 Baseline 24 Weeks 48 Weeks HIV RNA < 50 copies/mL (%)

Study Week Immediate Switch Delayed Switch

75/85 71/84 75/84 74/84 76/83 76/83

Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV

EASIER ANRS 138: Conclusions

Source: Gallien S, et al. J Antimicrob Chemother. 2011;66:2099-106.

Conclusions: “In well-suppressed patients with multidrug-resistant HIV infection, a switch from enfuvirtide to raltegravir is generally well tolerated and has sustained antiviral efficacy when combined with a potent background regimen.”

Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV

EASIER ANRS 138: Incidence of ALT Elevations

Week 24: ALT Elevation

Source: de Castro N, et al. AIDS Res Ther. 2016;13:17.

7.1 2.4 2 4 6 8 10 ALT elevation (≥ Grade 2) Patients (%)

Raltegravir Enfuvirtide

6/84 2/85

Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV

EASIER ANRS 138: Risk Factors for ALT Elevation

Source: de Castro N, et al. AIDS Res Ther. 2016;13:17.

Multivariate Analysis of Baseline Risk Factors for ALT Elevation (≥ Grade 2)

RISK FACTORS

Odds Ratio p value Use of boosted tipranavir 3.66 0.022 ALT elevation (≥ Grade 1) 10.3 < 0.001 Alcohol use (> 2 times/week) 0.39 0.281 Liver disease (steatosis/cirrhosis) 0.89 0.899

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.