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Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome

Cento, Valeria and Di Paolo, Daniele and Di Carlo, Domenico and Micheli, Valeria and Tontodonati, Monica and De Leonardi, Francesco and Aragri, Marianna and Antonucci, Francesco Paolo and Di Maio, Velia Chiara and Mancon, Alessandro and Lenci, Ilaria and Manunta, Alessandra and Taliani, Gloria and Di Biagio, Antonio and Nicolini, Laura Ambra and Nosotti, Lorenzo and Sarrecchia, Cesare and Siciliano, Massimo and Landonio, Simona Maria Chiara and Pellicelli, Adriano and Gasbarrini, Adriano and Vecchiet, Jacopo and Magni, Carlo Federico and Babudieri, Sergio and Mura, Maria Stella Anna and Andreoni, Massimo and Parruti, Giustino and Rizzardini, Giuliano and Angelico, Mario and Perno, Carlo Federico and Ceccherini-Silberstein, Francesca (2015) Hepatitis C virus RNA levels at week-2 of telaprevir/boceprevir administration are predictive of virological outcome. Digestive and liver disease, Vol. 47 (2), p. 157-163. ISSN 1590-8658. eISSN 1878-3562. Article.

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DOI: 10.1016/j.dld.2014.11.010

Abstract

Background: Triple therapy with telaprevir/boceprevir + pegylated-interferon + ribavirin can achieve excellent antiviral efficacy, but it can be burdened with resistance development at failure.
Aims: To evaluate kinetics of hepatitis C virus (HCV) RNA decay and early resistance development, in order to promptly identify patients at highest risk of failure to first generation protease inhibitors.
Methods: HCV-RNA was prospectively quantified in 158 patients receiving pegylatedinterferon + ribavirin + telaprevir (N = 114) or + boceprevir (N = 44), at early time-points and during per protocol follow-up. Drug resistance was contextually evaluated by population sequencing.
Results: HCV-RNA at week-2 was significantly higher in patients experiencing virological failure to triple-therapy than in patients with sustained viral response (2.3 [1.9–2.8] versus 1.2 [0.3–1.7] log IU/mL, p < 0.001). A 100 IU/mL cut-off value for week-2 HCV-RNA had the highest sensitivity (86%) in predicting virological success. Indeed, 23/23 (100%) patients with undetectable HCV-RNA reached success, versus 26/34 (76.5%) patients with HCV-RNA < 100 IU/mL, and only 11/31 (35.5%) with HCV-RNA > 100 IU/mL (p < 0.001). Furthermore, differently from failing patients, none of the patient with undetectable HCV-RNA at week-2 had baseline/early resistance.
, Giuliano Rizzardinil, Mario Angelicob,

Item Type:Article
ID Code:10802
Status:Published
Refereed:Yes
Uncontrolled Keywords:Early response, NS3 protease inhibitors, viral kinetics, virological failure
Subjects:Area 06 - Scienze mediche > MED/17 Malattie infettive
Divisions:001 Università di Sassari > 01-a Nuovi Dipartimenti dal 2012 > Medicina Clinica e Sperimentale
Publisher:Saunders / Elsevier
ISSN:1590-8658
eISSN:1878-3562
Deposited On:17 Feb 2015 12:51

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