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

Autor: Cento V; Department of Experimental Medicine and Surgery, University of Rome 'Tor Vergata', Rome, Italy., Di Paolo D; Hepatology Unit, University Hospital of Rome 'Tor Vergata', Rome, Italy., Di Carlo D; Department of Experimental Medicine and Surgery, University of Rome 'Tor Vergata', Rome, Italy., Micheli V; Unit of Microbiology, Hospital Sacco of Milan, Milan, Italy., Tontodonati M; Infectious Disease Clinic, Chieti, Italy; Infectious Disease Unit, Pescara General Hospital, Pescara, Italy., De Leonardis F; Hepatology Unit, University Hospital of Rome 'Tor Vergata', Rome, Italy., Aragri M; Department of Experimental Medicine and Surgery, University of Rome 'Tor Vergata', Rome, Italy., Antonucci FP; Department of Experimental Medicine and Surgery, University of Rome 'Tor Vergata', Rome, Italy., Di Maio VC; Department of Experimental Medicine and Surgery, University of Rome 'Tor Vergata', Rome, Italy., Mancon A; Unit of Microbiology, Hospital Sacco of Milan, Milan, Italy., Lenci I; Hepatology Unit, University Hospital of Rome 'Tor Vergata', Rome, Italy., Manunta A; Infectious Diseases Unit, Department of Clinical and Experimental Medicine, University of Sassari, Italy., Taliani G; 'La Sapienza' University, Rome, Italy., Di Biagio A; S. Martino Hospital, Genova, Italy., Nicolini LA; S. Martino Hospital, Genova, Italy., Nosotti L; Hepatology Unit, National Institute of Health, Migration and Poverty, Rome, Italy., Sarrecchia C; Infectious Disease, University Hospital of Rome 'Tor Vergata', Rome, Italy., Siciliano M; Gastroenterology, Catholic University of Rome, Rome, Italy., Landonio S; Division of Infectious Disease, Hospital Sacco of Milan, Milan, Italy., Pellicelli A; Hepatology Unit, San Camillo Forlanini Hospital, Rome, Italy., Gasbarrini A; Gastroenterology, Catholic University of Rome, Rome, Italy., Vecchiet J; Infectious Disease Clinic, Chieti, Italy., Magni CF; Division of Infectious Disease, Hospital Sacco of Milan, Milan, Italy., Babudieri S; Infectious Diseases Unit, Department of Clinical and Experimental Medicine, University of Sassari, Italy., Mura MS; Infectious Diseases Unit, Department of Clinical and Experimental Medicine, University of Sassari, Italy., Andreoni M; Infectious Disease, University Hospital of Rome 'Tor Vergata', Rome, Italy., Parruti G; Infectious Disease Unit, Pescara General Hospital, Pescara, Italy., Rizzardini G; Division of Infectious Disease, Hospital Sacco of Milan, Milan, Italy., Angelico M; Hepatology Unit, University Hospital of Rome 'Tor Vergata', Rome, Italy., Perno CF; Department of Experimental Medicine and Surgery, University of Rome 'Tor Vergata', Rome, Italy., Ceccherini-Silberstein F; Department of Experimental Medicine and Surgery, University of Rome 'Tor Vergata', Rome, Italy. Electronic address: ceccherini@med.uniroma2.it.
Jazyk: angličtina
Zdroj: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver [Dig Liver Dis] 2015 Feb; Vol. 47 (2), pp. 157-63. Date of Electronic Publication: 2014 Nov 24.
DOI: 10.1016/j.dld.2014.11.010
Abstrakt: 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 pegylated-interferon+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.
Conclusions: With triple therapy based on first generation protease inhibitors, suboptimal HCV-RNA decay at week-2 combined with early detection of resistance can help identifying patients with higher risk of virological failure, thus requiring a closer monitoring during therapy.
(Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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