5 research outputs found
Brief HTA report: Genotipo di polimorfismi del gene dell’IL28B (IFNL3): utilizzo clinico in pazienti con HCV
No full textBackground:
PEG-Interferon-α and Ribavirin association is currently the standard regimen for treatment of patients suffering from HCV infection. The genotype of polymorphisms located in the IL28B (IFNL3) gene is considered a reliable predictor of response to therapy, as measured by the mean of the sustained virologic response (SVR).
Aims:
The purpose of the present document is to provide information about the application in the clinical practice of the pharmacogenetic test based on IL28B genotyping to guide the administration of PEG-Interferon-α-based therapy in patients with HCV infection. The use of this test within the Regional Health System was also evaluated. Economic evaluations were not considered.
Methods:
A focused literature review was accomplished; a systematic search was performed to identify available systematic reviews and meta-analyses. A telephone survey was performed to identify laboratories offering the IL28B pharmacogenetic test within the Regional Health System and collect current activity.
Analytic validity:
The genetic test is routinely based on real-time PCR allelic discrimination of the rs12979860 single nucleotide polymorphism. Despite the lack of large studies on the analytic performance, the test procedure is robust and was reported to be readily implemented in the pipeline of molecular pathology laboratories.
Clinical validity:
According to all the meta-analyses reviewed in the present assessment, the genotype of the IL28B rs12979860 polymorphism is a valid predictor of sustained virologic response in previously untreated patients with HCV. Carriers of the rs12979860 CC genotype show a more favourable response rate, as compared to non-CC carriers. Genotyping of other IL28B polymorphisms is not suggested.
The association between response and IL28B genotypes was demonstrated for HCV genotype 1 and 4, while in genotype 2 and 3 was not definitely confirmed. The association with other endpoints, such as the rapid virologic response, was not extensively studied.
Clinical utility:
Though the sustained virologic response can be considered a valid measure of the clinical outcome and was widely used as endpoint in clinical studies, no evidence was found supporting the hypothesis that a regimen guided by IL28B genotyping is associated with a more favourable clinical outcome with respect to standard protocol. No clinical measure of efficacy, other than virologic response, was consistently evaluated in primary studies. Also occurrence of adverse events was not explored in association studies on IL28B genotype.
Noteworthy, a multivariate model including both clinical variables and IL28B genotyping as predictors was preliminarily demonstrated to more accurately predict virologic response with respect to IL28B alone. Clinical pathways incorporating the pharmacogenetic test of IL28B were not formally evaluated in clinical trials and currently are not recommended in clinical guidelines. Ongoing studies were found in the clinical trial database.
There is no literature exploring the ethical, legal and social implications of IL28B testing. However, this type of test does not raise specific concerns, provided that good practices are applied.
Provision of IL28B genotyping by laboratories of the Regional Health System:
The survey detected three laboratories offering pharmacogenetic IL28B testing. Approximately 550 test/year were performed in the 2012-2013 period.
The ability of each laboratory to perform a larger number of test should be further estimated. It could also be considered to what extent efficiency can be improved by gathering samples in one laboratory. In addition, it should be also investigated to what extent laboratories performing few tests can guarantee a timely response, as this is a critical requisite to guarantee the proper use of the pharmacogenetic tests
Rete HTA- Regione Liguria - Criteri per l'appropriatezza allocativa di alcune apparecchiature - Volume 1 Acceleratori Lineari -LINAC
No full text"Sailing around the World (1857-1859). Colonial Patterns, Native Societies, Global Resources in the Circumnavigation of the Austrian Frigate Novara"
No full textThis essay by Guido Abbattista analyzes the Austrian frigate Novara’s circumnavigation (1857–1859) as a paradigmatic case of nineteenth-century global exploration, set within the broader context of European imperial expansion and scientific ambition. Abbattista demonstrates how the Novara expedition, Austria’s first global voyage, was not only a naval and scientific enterprise but also a vehicle for projecting imperial prestige, asserting national identity, and gathering knowledge about colonial patterns, native societies, and global resources. Drawing on official reports, scientific publications, and ethnographic collections, the essay situates the Novara alongside other Austrian and European voyages, highlighting its role in consolidating Austria’s place on the world stage. The author explores the ideological underpinnings of the mission, especially as articulated by Karl von Scherzer, who framed the journey in terms of Eurocentric progress, racial hierarchies, and the civilizing mission of Europe—particularly the “Anglo-Saxon” model. The essay critically examines how the Novara’s documentation and collections contributed to museums and scientific institutions, while also reflecting the contradictions and exclusions of imperialist worldviews. Ultimately, Abbattista argues that the Novara expedition exemplifies the entanglement of science, empire, and global modernity, offering insight into the construction of “global Europeanness” and the enduring legacies of colonial encounters
Clinical and organizational evidence of the efficacy and effectiveness from cardiac rehabilitation: an update
No full textThe increasing evidence on the favourable cost/effectiveness impact of the comprehensive cardiac rehabilitation program for the treatment of a wide spectrum of cardiovascular conditions have imposed to healthcare services a major attention on a critical analysis of the results in different clinical indications and delivery organisations. The Regional Health Agency of Liguria, in the occasion of drawing up regional guidelines directed to define the clinical indications and the effectiveness of the cardiac rehabilitation delivery model (in-patients, out-patients and home-based) and its requisites, indications and procedures, has updated the reference guidelines (PLNG and SIGN) with the evidence provided by the more recent literature, focusing its attention on the clinical and, in particular, organizational effectiveness. The document, on the base of these evidences, provides some effective proposals and some organizational advices
