Background: The Raltegravir Switch for Toxicity or Adverse Events (RASTA) Study is a 2-arm randomized pilot study exploring the safety and efficacy at 48 weeks of a treatment switch to raltegravir associated with tenofovir/emtricitabine or abacavir/lamivudine in patients with regimens with optimal virological control. Methods: Patients treated with stable protease inhibitor (PI)-, non-nucleoside reverse transcriptase inhibitor (NNRTI)-, or nucleoside reverse transcriptase inhibitor (NRTI)-based regimens, with HIV-RNA levels <50 copies/ml for >= 3 months and a CD4 cell count >200 cells/mu l were eligible. Enrollment of 40 patients was planned: at baseline patients were randomized 1: 1 to switch to raltegravir plus tenofovir/emtricitabine (arm A) or abacavir/lamivudine (arm B). Laboratory parameters, raltegravir plasma levels, self-reported adherence, quality of life parameters, neurocognitive performance, bone composition, and body fat distribution were monitored. Virological failure was defined as HIV-RNA >50 copies/ml on 2 consecutive determinations. Results: After 48 weeks, 5/40 (12.5%) regimen discontinuations occurred: 2 were for low-level viremia virological failure (both in arm A, at weeks 24 and 48) and 3 were for adverse events (neurological disturbances and skin rash in arm B; proximal tubulopathy in arm A). Overall, a significant CD4 increase was observed at weeks 36 and 48, and a significant decrease in total cholesterol, non-high density lipoprotein cholesterol, and triglycerides was observed at each study visit. Physical health/satisfaction in therapy scores and neuropsychological performance improved. The lumbar column Z-score improved, with no modification in other bone composition and fat distribution parameters. Conclusions: The investigated switch strategy was associated with rare virological failure. Improvements in lipid levels, quality of life measures, neuropsychological performance, and bone composition suggest good tolerability of raltegravir-based regimens.

Safety and efficacy of treatment switch to raltegravir plus tenofovir/emtricitabine or abacavir/lamivudine in patients with optimal virological control: 48-week results from a randomized pilot study (Raltegravir Switch for Toxicity or Adverse Events, RASTA Study) / Massimiliano, Fabbiani; Annalisa, Mondi; Manuela, Colafigli; D'Ettorre, Gabriella; Francesca, Paoletti; Alessandro, D'Avino; Nicoletta, Ciccarelli; Letizia, Sidella; Rita, Murri; Serena, Fortuna; Vullo, Vincenzo; Roberto, Cauda; Andrea De, Luca; Simona Di, Giambenedetto. - In: SCANDINAVIAN JOURNAL OF INFECTIOUS DISEASES. - ISSN 0036-5548. - ELETTRONICO. - 46:1(2014), pp. 34-45. [10.3109/00365548.2013.840920]

Safety and efficacy of treatment switch to raltegravir plus tenofovir/emtricitabine or abacavir/lamivudine in patients with optimal virological control: 48-week results from a randomized pilot study (Raltegravir Switch for Toxicity or Adverse Events, RASTA Study)

D'ETTORRE, Gabriella;VULLO, Vincenzo;
2014

Abstract

Background: The Raltegravir Switch for Toxicity or Adverse Events (RASTA) Study is a 2-arm randomized pilot study exploring the safety and efficacy at 48 weeks of a treatment switch to raltegravir associated with tenofovir/emtricitabine or abacavir/lamivudine in patients with regimens with optimal virological control. Methods: Patients treated with stable protease inhibitor (PI)-, non-nucleoside reverse transcriptase inhibitor (NNRTI)-, or nucleoside reverse transcriptase inhibitor (NRTI)-based regimens, with HIV-RNA levels <50 copies/ml for >= 3 months and a CD4 cell count >200 cells/mu l were eligible. Enrollment of 40 patients was planned: at baseline patients were randomized 1: 1 to switch to raltegravir plus tenofovir/emtricitabine (arm A) or abacavir/lamivudine (arm B). Laboratory parameters, raltegravir plasma levels, self-reported adherence, quality of life parameters, neurocognitive performance, bone composition, and body fat distribution were monitored. Virological failure was defined as HIV-RNA >50 copies/ml on 2 consecutive determinations. Results: After 48 weeks, 5/40 (12.5%) regimen discontinuations occurred: 2 were for low-level viremia virological failure (both in arm A, at weeks 24 and 48) and 3 were for adverse events (neurological disturbances and skin rash in arm B; proximal tubulopathy in arm A). Overall, a significant CD4 increase was observed at weeks 36 and 48, and a significant decrease in total cholesterol, non-high density lipoprotein cholesterol, and triglycerides was observed at each study visit. Physical health/satisfaction in therapy scores and neuropsychological performance improved. The lumbar column Z-score improved, with no modification in other bone composition and fat distribution parameters. Conclusions: The investigated switch strategy was associated with rare virological failure. Improvements in lipid levels, quality of life measures, neuropsychological performance, and bone composition suggest good tolerability of raltegravir-based regimens.
2014
hiv; toxicity; antiretroviral therapy; treatment simplification; raltegravir
01 Pubblicazione su rivista::01a Articolo in rivista
Safety and efficacy of treatment switch to raltegravir plus tenofovir/emtricitabine or abacavir/lamivudine in patients with optimal virological control: 48-week results from a randomized pilot study (Raltegravir Switch for Toxicity or Adverse Events, RASTA Study) / Massimiliano, Fabbiani; Annalisa, Mondi; Manuela, Colafigli; D'Ettorre, Gabriella; Francesca, Paoletti; Alessandro, D'Avino; Nicoletta, Ciccarelli; Letizia, Sidella; Rita, Murri; Serena, Fortuna; Vullo, Vincenzo; Roberto, Cauda; Andrea De, Luca; Simona Di, Giambenedetto. - In: SCANDINAVIAN JOURNAL OF INFECTIOUS DISEASES. - ISSN 0036-5548. - ELETTRONICO. - 46:1(2014), pp. 34-45. [10.3109/00365548.2013.840920]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/610211
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