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Switching to the Single-Tablet Regimen (STR) Emtricitabine / Rilpivirine / Tenofovir DF from a Ritonavir-boosted Protease Inhibitor & 2 NRTI Regimen Maintains HIV Suppression and is Well Tolerated in HIV+ Subjects at Week 24 Regardless of Age: SPIRIT Study
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Reported by Jules Levin
52nd ICAAC Sept 9-12 SF 2012
D. Shamblaw1, F. Palella2, P. Ruane3, P. Tebas4, B. Gazzard5, M. Fisher6, J. v Lunzen7, J. Flamm8, M. Wang9, K. White9, H. Graham9, B. Guyer9, T. Fralich9, S.K. Chuck91La Playa Medical Group and Clinical Research, San Diego, USA; 2Northwestern University, Chicago, USA;3Peter J. Ruane, MD, Inc, Los Angeles, USA; 4University of Pennsylvania, Philadelphia, USA; 5Chelsea and Westminster Hospital Foundation Trust, London, UK; 6Brighton and Sussex University Hospitals, Brighton, UK; 7University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 8Kaiser Permanente, Sacramento, USA; 9Gilead Sciences, Foster City, USA
ABSTRACT
Background: Advancing age among antiretroviral (ART)-treated HIV-infected persons necessitates more ART long-term safety & efficacy data in older patients. ART simplification strategies particularly need to be studied to evaluate treatment benefits relative to safety concerns.
Methods: This on-going, randomized (2:1), open-label, 48-wk study evaluates safety & efficacy of continuing PI+RTV regimens or switching to STR FTC/RPV/TDF in virologically-suppressed adults (VL<50 c/mL).
Results: At Wk 24, STR FTC/RPV/TDF was non-inferior to PI+RTV in maintaining VL<50 (93.7% vs 89.9%; 95%CI -1.6, 9.1). A post hoc analysis by age (≤ or > 40 yrs) is presented. In both age strata, STR FTC/RPV/TDF switch was well tolerated with non-inferior efficacy [95%CI: -6.6, 6.5 (>40) & -0.1, 18.4 (≤40)], lower VF and significant improvements in TC, LDL, TC:HDL & TG vs. PI+RTV. Changes in CD4 & CrCl were not clinically significant.
Conclusions: At Wk 24, regardless of age, HIV-suppressed subjects switching to STR FTC/RPV/TDF from PI+RTV regimens demonstrated non-inferior virologic efficacy, with a low risk of VF, and few AE-related treatment discontinuations (≤2.3%) vs PI+RTV.
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