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Simplification to Abacavir/Lamivudine + Atazanavir from Tenofovir/Emtricitabine + Atazanavir/Ritonavir Maintains Viral Suppression and Improves Bone Biomarkers
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Reported by jules Levin
52nd ICAAC Sept 9-12 2012 SF
D Wohl1, L Bhatti 2, CB Small3, H Edelstein4, H Zhao5, D Margolis5, L Ross5, M Shaefer6
1AIDS Clin Trials Unit, UNC CH, Chapel Hill, NC, 2AIDS Healthcare Foundation, Beverly Hills, CA, 3New York Medical College, Vahalla, NY, 4Alameda County Medical Center, Oakland, CA, 5GlaxoSmithKline, RTP, NC, 6ViiV Healthcare, RTP, NC.
ABSTRACT
Background: Simplification of ART in patients with suppressed viremia may minimize long-term adverse effects and costs.
Methods: ASSURE is an open-label, multicenter, non-inferiority study of subjects with confirmed HIV RNA <75 c/mL, ≥ 6 months' treatment with TDF/FTC +ATV/r as last regimen and eCrCL ≥50 mL/min. Subjects were randomized 2:1 to initiate ABC/3TC + ATV or continue TDF/FTC + ATV/r. The primary endpoint was % with HIV RNA <50 c/mL at Wk 24 by the Time to Loss Of Virologic Response (TLOVR) algorithm.
Results: Baseline (BL) demographics of the 296 ITTe subjects: median age 44 yrs; 79% male; 60% white; median HIV RNA <40 c/mL; median CD4+ 492 cells/mm3; results were also similar between arms. 268/296 (91%) completed 24 wks.
The bone and renal biomarkers bone alkaline phosphatase, c-telopeptide, osteocalcin, ß2 microglobulin and parathyroid hormone all declined significantly (p<0.001) from BL for the ABC/3TC + ATV arm, with no significant change for the TDF/FTC + ATV/r arm. No significant change from BL was seen by treatment arm for the inflammatory biomarkers hsCRP, IL-6 or D-Dimer. Of fasting lipids, only HDL increased significantly (4 mg/dL; p<0.001) from BL for the simplification arm.
Conclusions: At 24 wks, simplification to ABC/3TC+ATV from a RTV-containing regimen maintained viral suppression, was well-tolerated, and led to improvements in bone markers and HDL cholesterol.
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