Presentation Abstract

Session: 099-Antiretroviral Therapy of HIV-1 Infection
Sunday, Sep 18, 2011, 11:15 AM - 1:15 PM
Presentation Title: H2-787 - Removing an Inactive NRTI from an Effective Salvage Regimen is Safe and Maintains Virologic Suppression. Week 24 Results from the VERITAS Trial
Location: Exhibit Hall F1
Poster Board Number: 274
Presentation Number: H2-787
Pres. Time: Sunday, Sep 18, 2011, 11:15 AM - 1:15 PM
Category: H2
Keywords: non active drugs; salvage regimen; trials
Author(s): B. Trottier, MD (Doctor of Medicine) - physician, N. Machouf - epidemiologist, D. Longpre - physician, H. Dion - physician, S. Vezina - physician, S. Lavoie - physician, D. Murphy - physician, R. Thomas - physician;
Clinique medicale l'Actuel, Montreal, Canada.
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Abstract: Background: In patients with multi-drug-resistant (MDR) virus, NRTIs often have little activity, may add toxicity, drug interactions, and extra cost. Nonetheless, clinicians prescribe them, and guidelines don’t take any position on the pertinence of keeping them in an effective salvage regimen. A simplification treatment strategy of removing non-active NRTIs, as determined by genotypic data, was studied to evaluate its virologic, immunological, clinical and financial outcome. Methods: MDR patients with undetectable viral load (VL) on a stable regimen containing at least one non-active NRTI were enrolled in a single arm, open-label, prospective trial of simplification. Proportion of patients maintaining viral suppression was evaluated, along with immunological response and toxicity at week 24. Results:We enrolled 31 patients, 100% men, 94% MSM, mean age 50 years (IQR: 46-56). Patients were treated since 14 years (IQR: 12-16), with a median CD4 of 525 cells/mm3 (IQR: 360-680) at baseline and a nadir of 158 (IQR: 69-210). The baseline regimen comprise 4 antiretrovirals (ARV) in 22 patients (71%) and 5 ARV in 9 patients (29%). The drugs that were removed: 3TC or FTC in 29 (94%), AZT in one and TDF in one patient. After 24 weeks of simplification, 100% of the patients remained with undetectable VL, with a gain of CD4 of 13 cell/mm3 (p=0.564). No one ended up with CD4≤200. No new grade ≥2 laboratory abnormality was observed, nor any death or serious adverse event. Conclusions: Removing non-active NRTI from a regimen with ≥4 ARV in patients with suppressed VL appears to be safe and did not affect the ability of the regimen to maintain the VL under the limit of detection through 24 weeks. Further studies are warranted to evaluate the amount of money saved in direct cost with this simplified regimen.

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