Simplification to Abacavir-Lamivudine Atazanavir Maintains Viral Suppression and Improves Bone and Renal Biomarkers in ASSURE, a Randomized, Open Label, Non-Inferiority TrialReportar como inadecuado




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Objective

Simplification of antiretroviral therapy in patients with suppressed viremia may minimize long-term adverse effects. The study’s primary objective was to determine whether abacavir-lamivudine + atazanavir ABC-3TC+ATV was virologically non-inferior to tenofovir-emtricitabine + atazanavir-ritonavir TDF-FTC+ATV-r over 24 weeks in a population of virologically suppressed, HIV-1 infected patients.

Design

This open-label, multicenter, non-inferiority study enrolled antiretroviral experienced, HIV-infected adults currently receiving a regimen of TDF-FTC+ATV-r for ≥6 months with no history of virologic failure and whose HIV-1 RNA had been ≤75 copies-mL on 2 consecutive measurements including screening. Patients were randomized 1∶2 to continue current treatment or simplify to ABC-3TC+ATV.

Methods

The primary endpoint was the proportion of patients with HIV-RNA<50 copies-mL at Week 24 by the Time to Loss of Virologic Response TLOVR algorithm. Secondary endpoints included alternative measures of efficacy, adverse events AEs, and fasting lipids. Exploratory endpoints included inflammatory, coagulation, bone, and renal biomarkers.

Results

After 24 weeks, ABC-3TC+ATV n = 199 was non-inferior to TDF-FTC+ATV-r n = 97 by both the primary analysis 87% in both groups and all secondary efficacy analyses. Rates of grade 2–4 AEs were similar between the two groups 40% vs 37%, respectively, but an excess of hyperbilirubinemia made the rate of grade 3–4 laboratory abnormalities higher in the TDF-FTC+ATV-r group 30% compared with the ABC-3TC+ATV group 13%. Lipid levels were stable except for HDL cholesterol, which increased significantly in the ABC-3TC+ATV group. Bone and renal biomarkers improved significantly between baseline and Week 24 in patients taking ABC-3TC+ATV, and the difference between groups was significant at Week 24. No significant changes occurred in any inflammatory or coagulation biomarker within or between treatment groups.

Conclusions

After 24 weeks, simplification to ABC-3TC+ATV from TDF-FTC+ATV-r maintained viral suppression was well-tolerated, and led to improvements in bone and renal biomarkers and HDL cholesterol.

Trial Registration

ClinicalTrials.gov NCT01102972GlaxoSmithKline Clinical Study Register #113734



Autor: David A. Wohl , Laveeza Bhatti, Catherine B. Small, Howard Edelstein, Henry H. Zhao, David A. Margolis, Edwin DeJesus, Winkler G.

Fuente: http://plos.srce.hr/



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