Abstract | BACKGROUND: 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.
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Authors | Antonia Lepida, Massimo Colombo, Inmaculada Fernandez, Djamal Abdurakhmanov, Paulo Abrao Ferreira, Simone I Strasser, Petr Urbanek, Alessandra Mangia, José L Calleja, Wafae Iraqi, Ralph DeMasi, Isabelle Lonjon-Domanec, Christophe Moreno, Heiner Wedemeyer |
Journal | PloS one
(PLoS One)
Vol. 10
Issue 9
Pg. e0138503
( 2015)
ISSN: 1932-6203 [Electronic] United States |
PMID | 26398503
(Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Aged
- Anemia
(etiology)
- Biomechanical Phenomena
(drug effects)
- Female
- Health Services Accessibility
- Hepacivirus
(drug effects, physiology)
- Hepatitis C
(complications, drug therapy, physiopathology, virology)
- Humans
- Intention to Treat Analysis
- Liver
(drug effects, pathology, physiopathology)
- Liver Cirrhosis
(complications, drug therapy, physiopathology)
- Male
- Middle Aged
- Multivariate Analysis
- Oligopeptides
(adverse effects, pharmacology, therapeutic use)
- Risk Factors
- Treatment Outcome
- Young Adult
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