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)

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; Luca, Andrea De; Giambenedetto, Simona Di

doi:10.3109/00365548.2013.840920

Cited by 23 publications

(8 citation statements)

References 37 publications

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“…Management options for TC and/or LDL-C elevations in HIV-infected children include life-style and dietary changes, or switching to ARVs less likely to elevate lipid concentrations 77-81 . If lipid concentrations do not improve with these interventions or for individuals in whom such interventions are not feasible, our data suggest that treatment with atorvastatin appears to be safe and effective for HIV-infected youth on ART.…”

Section: Resultsmentioning

confidence: 99%

Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia

Melvin

Montepiedra

Aaron

et al. 2017

Pediatric Infectious Disease Journal

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Background HIV-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population. Methods HIV-infected youth aged 10 - < 24 years on stable ART with low-density lipoprotein-cholesterol (LDL-C) ≥130 mg/dL for ≥ 6 months initiated atorvastatin 10mg once daily. Atorvastatin was increased to 20mg if LDL-C efficacy criteria (LDL-C < 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy. Results Twenty-eight youth initiated atorvastatin; 7 were 10 - 15 years and 21 were 15 - 24 years. Mean baseline LDL-C was 161mg/dL (sd 19mg/dL). Efficacy criteria were met at week 4 by 17/27(63%). Atorvastatin was increased to 20mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% CI: 26%, 35%) at week 4, 28% (90% CI: 23%, 33%) at week 24, and 26% (90% CI: 20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12, and 46% at weeks 24 and 48.Total cholesterol (TC), non-high-density lipoprotein (non-HDL)-C and apolipoprotein B (ApoB) decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin. Conclusions Atorvastatin lowered TC, LDL-C, non-HDL-C and ApoB in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infected children with hyperlipidemia, but safety monitoring is important particularly in younger children.

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Section: Resultsmentioning

confidence: 99%

Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia

Melvin

Montepiedra

Aaron

et al. 2017

Pediatric Infectious Disease Journal

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“…8 Finally, in the RASTA study only two of the 40 subjects included (5%) discontinued treatment for virological failure. 9 The KIRAL study, a recent multicentre, non-controlled, retrospective study, assessed the efficacy of ABC/3TC plus RAL in 380 virologically-suppressed patients, showing a high virological suppression rate at 48 weeks (97.6% of subjects with HIV-RNA <50 copies/mL). 10 With regard to the metabolic profile, as already mentioned, we observed a significant difference in triglycerides between mean values before the switch to ABC/3TC plus RAL and mean values at the latest measurement.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of abacavir/lamivudine with raltegravir in treatment-experienced and treatment-naïve patients with HIV-1 infection: an observational, retrospective, multi-centre study

et al. 2019

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Raltegravir (RAL) is an HIV-1 integrase strand transfer inhibitor that is well established as a component of highly active antiretroviral therapy regimens for the treatment of adults living with human immunodeficiency virus (HIV), due to its high virological efficacy and good tolerability profile. To date, limited data are available on the use of RAL with abacavir/lamivudine (ABC/3TC). We investigated retrospectively 62 HIV-1 infected patients managed by three Italian Infectious Diseases Outpatient Departments, including 57 treatment-experienced patients and 5 treatment-naïve patients, treated with ABC/3TC plus RAL. In all five naïve patients (100%), virological suppression was achieved and maintained , while 55 experienced patients (96.5%) maintained viral suppression at the most recent review. In the treatment-experienced patients, we observed a significant decrease in triglyceride levels (p < 0.01), while liver transaminases, renal function and cholesterol levels remained substantially stable. In the 34 treatment-experienced patients who switched from a protease inhibitor (PI)-based regimen, we observed a significant improvement of total cholesterol (p=0.03) and triglyceride (p < 0.01) levels. No significant alterations were found on renal and liver function and serum lipid profile of treatment-naïve patients. Despite the small number of participants, results support the efficacy and safety of ABC/3TC plus RAL, either in treatment-naïve or treatment-experienced patients.

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“…Estos hallazgos son concordantes con los resultados de los ensayos clínicos publicados a la fecha, en todos los cuales el cambio de TAR a un esquema basado en RAL se asoció a un descenso significativo en las concentraciones plasmáticas de CT y TG (Tabla 4) [9][10][11][12][13] . Sin embargo, cabe destacar que la magnitud del cambio de los lípidos observado en nuestra cohorte fue mayor a lo reportado en los citados estudios, lo cual podría explicarse porque los sujetos que incluimos tenían mayores concentraciones plasmáticas de lípidos basales (todos tenían dislipidemia) y en su mayoría habían debutado con hiperlipidemia después de iniciar la TAR, factores que en nuestro análisis exploratorio se asociaron con un descenso de los lípidos de mayor magnitud.…”

Section: Discussionunclassified

Efectividad y seguridad del cambio a esquema basado en raltegravir en pacientes con infección por VIH dislipidémicos bajo terapia anti-retroviral en Fundación Arriarán

Ocampo

Vera

Wolff

2019

Rev. chil. infectol.

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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)

Abstract: 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.

Cited by 23 publications

References 37 publications

Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia

Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia

Efficacy and safety of abacavir/lamivudine with raltegravir in treatment-experienced and treatment-naïve patients with HIV-1 infection: an observational, retrospective, multi-centre study

Efectividad y seguridad del cambio a esquema basado en raltegravir en pacientes con infección por VIH dislipidémicos bajo terapia anti-retroviral en Fundación Arriarán

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