Dataset Information
The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviral-naive patients. Impact on bone health.
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ABSTRACT: Background
NRTI-sparing regimens may avoid long-term mitochondrial, bone and renal toxicities and maintain viral suppression.Methods
In the RADAR study, 85 antiretroviral-naïve HIV-infected patients were randomized to receive either raltegravir (RAL) (n?=?42) or tenofovir/emtricitabine (TDF/FTC) (n?=?43), each with ritonavir-boosted darunavir (DRV/r). Virologic efficacy was assessed at weeks 24 and 48. Bone mineral density (BMD) was assessed by dual energy X-ray absorptiometry (DXA) scan at baseline and week 48, and bone turnover markers (BTM) assessed at weeks 0, 16 and 48.Results
Using an intention-to-treat analysis, 62.5% of RAL subjects and 83.7% of TDF/FTC subjects were responders (VL<48 copies/mL) at week 48 (p?=?0.045; chi-square test). The proportions of patients achieving VL<200 copies/mL were similar: 72.5% and 86.0% (p?=?0.175). Premature treatment discontinuation was the main cause for failure. No treatment-emergent resistance was observed. Changes from baseline in RAL vs. TDF/FTC for CD4+ (+199 vs. +216 cells/µL, p?=?0.63), total cholesterol/HDL (-0.25 vs. -0.71 mg/dL (p?=?0.270), and eGFR (-4.4 vs. -7.9 ml/min, p?=?0.44) were comparable between groups. Changes in subtotal BMD to week 48 were: +9.2 with RAL vs. -7 g/cm2 with TDF/FTC (p?=?0.002). Mean CTX changes were +0.04 vs. +0.24 ng/mL (p?=?0.001), and mean P1NP changes were +3.59 vs. +30.09 ng/mL (p?=?0.023). BTM changes at week 16 predicted change in BMD by week 48 (R?=?-0.394, p?=?0.003 for CTX; and R?=?-0.477, p<0.001 for P1NP).Conclusion
The NRTI-sparing regimen RAL+DRV/r did not achieve similar week 48 virologic efficacy compared with TDF/FTC+DRV/r, but was better with regard to markers of bone health.Trial registration
ClinicalTrials.gov NCT 00677300.
SUBMITTER: Bedimo RJ
PROVIDER: S-EPMC4149560 | biostudies-literature | 2014
REPOSITORIES: biostudies-literature
Publications
The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviral-naive patients. Impact on bone health.
PloS one 20140829 8
<h4>Background</h4>NRTI-sparing regimens may avoid long-term mitochondrial, bone and renal toxicities and maintain viral suppression.<h4>Methods</h4>In the RADAR study, 85 antiretroviral-naïve HIV-infected patients were randomized to receive either raltegravir (RAL) (n = 42) or tenofovir/emtricitabine (TDF/FTC) (n = 43), each with ritonavir-boosted darunavir (DRV/r). Virologic efficacy was assessed at weeks 24 and 48. Bone mineral density (BMD) was assessed by dual energy X-ray absorptiometry (D ...[more]