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 Study Design: EASIER ANRS 138 • Background : Open label, randomized trial evaluating switching from enfuvirtide-based Immediate Switch Arm therapy to raltegravir-based therapy, in Raltegravir 400 mg BID virologically suppressed patients with multidrug + Background Regimen resistant HIV-1 infection. (n = 84) • Inclusion Criteria (n = 170) - Age ≥18 years - HIV RNA <400 copies/mL for >3 months Delayed Switch Arm - History of triple class failure (PI, NRTI, NNRTI) Enfuvirtide x 24 weeks, then - Integrase inhibitor naïve Raltegravir 400 mg BID + Background Regimen • Treatment Arms (n = 84) - Raltegravir 400 mg BID + background regimen - Enfuvirtide + background regimen x 24 weeks, then switch enfuvirtide to raltegravir 400 mg BID Source: Gallien S, et al. J Antimicrob Chemother. 2011;66:2099-106.
Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV EASIER ANRS 138: Results Virologic Response (Intent-to-Treat Analysis, censoring missing data) Immediate Switch Delayed Switch 100 HIV RNA < 50 copies/mL (%) 90 90 89 88 88 80 85 60 40 20 75/85 71/84 75/84 74/84 76/83 76/83 0 Baseline 24 Weeks 48 Weeks Study Week Source: Gallien S, et al. J Antimicrob Chemother. 2011;66:2099-106.
Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV EASIER ANRS 138: Conclusions 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.” Source: Gallien S, et al. J Antimicrob Chemother. 2011;66:2099-106.
Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV EASIER ANRS 138: Incidence of ALT Elevations Week 24: ALT Elevation Raltegravir Enfuvirtide 10 8 7.1 Patients (%) 6 4 2.4 2 6/84 2/85 0 ALT elevation (≥ Grade 2) Source: de Castro N, et al. AIDS Res Ther. 2016;13:17.
Switch from Enfuvirtide to Raltegravir in Multidrug-Resistant HIV EASIER ANRS 138: Risk Factors for ALT Elevation Multivariate Analysis of Baseline Risk Factors for ALT Elevation (≥ Grade 2) Odds Ratio p value RISK FACTORS 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 Source: de Castro N, et al. AIDS Res Ther. 2016;13:17.
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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