Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or CirrhosisReportar como inadecuado




Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Background

Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002.

Methods

1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin PR for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients 72% had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4.

Results

Overall, 1,139 patients 64% achieved a sustained virological response SVR by intention-to-treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events.

Conclusions

FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.

Trial Registration

ClinicalTrials.gov NCT01508286



Autor: Antonia Lepida, Massimo Colombo, Inmaculada Fernandez, Djamal Abdurakhmanov, Paulo Abrao Ferreira, Simone I. Strasser, Petr Urban

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



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