Presentation Abstract

Session: 099-Antiretroviral Therapy of HIV-1 Infection
Sunday, Sep 18, 2011, 11:15 AM - 1:15 PM
Presentation Title: H2-785 - Pilot Study to Assess the Efficacy and Safety of Switching Protease Inhibitor to Once-Daily Etravirine in HIV-1-Infected Subjects with Viral Suppression: Etra-Switch Study
Location: Exhibit Hall F1
Poster Board Number: 272
Presentation Number: H2-785
Pres. Time: Sunday, Sep 18, 2011, 11:15 AM - 1:15 PM
Category: H2
Keywords: Etravirine Switching; Efficacy; Safety
Author(s): P. Echeverría - Physician1,2, A. Bonjoch, PhD - Physician 1, J. Puig - Nurse 1, R. Paredes, PhD - Physician 1, J. Moltó, PhD - Physician 1, G. Sirera, PhD - Physician 1, B. Clotet, PhD - Physician 1,2, E. Negredo, PhD - Physician 1;
1Hosp. Germans Trias i Pujol, Barcelona, Spain, 2Autonomous Univ. of Barcelona, Barcelona, Spain.
Financial Disclosures:  P. Echeverría, None..
A. Bonjoch, None..
J. Puig, None..
R. Paredes, None..
J. Moltó, None..
G. Sirera, None..
B. Clotet, None..
E. Negredo, None.
Abstract: Background: Etravirine (ETR) is an antiretroviral drug approved for clinical use in adults with incomplete virologic suppression and resistance to previous NNRTI. We designed a study to evaluate the efficacy and safety of switching protease inhibitor (PI) to ETR in virologically suppressed subjects as a simplification strategy. Methods: Randomized clinical trial in HIV-1 infected patients receiving a triple-drug PI-based regimen for >12 months and VL<50 copies/mL for >6 months. Patients were allocated to switch the PI to ETR (400mg/24hours, tablets dissolved in water) (ETR group), or to continue with the same regimen (Control group). A preliminary analysis was performed when patients reached week 24. Results: Forty-six patients were included, 24 in ETR group and 22 in Control group. At week 24, all patients maintained VL<50 copies/mL. A slight increase in CD4+ T-cells was seen in both groups: from 702 to 795 cell/mm3 (p=0.177) in ETV and from 704 to 743 cell/mm3 ( p=0.107) in Control group, with significant differences only in perceptual CD4+ in ETR group (from 32% to 34%, p=0.025). A reduction in total cholesterol (from 206 to 186 mg/dL, p=0.037) and triglycerides (from 168 to 107 mg/dL, p= 0.004) was observed only in the ETR group. Median (IQR) though concentration of ETR in plasma was: 577 ng/mL. No patients showed a plasma though level < 4 ng/mL. One subject from ETR group and 2 from the Control group discontinued therapy (voluntary discontinuation). Patient’s satisfaction, evaluated by a questionnaire, showed an improvement in ETR group. Conclusions: Treatment simplification to once-daily ETR seems to be safe and effective in HIV-infected patients with virological suppression while receiving PI-based antiretroviral treatment. This strategy permits once-daily dosing and results in improvements in lipid profile and patients satisfaction while maintaining viral suppression.

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