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). (January 2014)

• Record Type: Journal Article
• Authors: Fabbiani, Massimiliano; Mondi, Annalisa; Colafigli, Manuela; D'Ettorre, Gabriella; Paoletti, Francesca; D'Avino, Alessandro; Ciccarelli, Nicoletta; Sidella, Letizia; Murri, Rita; Fortuna, Serena; Vullo, Vincenzo; Cauda, Roberto; De Luca, Andrea; Di Giambenedetto, Simona
• Is Part Of: Scandinavian journal of infectious diseases. Volume 46:Number 1(2014:Jan.)
• Page Start: 34
• Page End: 45
• Publication Date: 2014-01
• Subjects: HIV -- antiretroviral therapy -- toxicity -- treatment simplification -- raltegravir; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.9
• DOI: 10.3109/00365548.2013.840920
• Languages: English
• ISSNs: 0036-5548

Abstract

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/μl 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.