title: The clinical significance of HCV core antigen detection during Telaprevir/Peg-Interferon/Ribavirin therapy in patients with HCV 1 genotype infection.
abstract: BACKGROUND
  Direct-acting antiviral drugs (DAA) regimen improve the SVR rate. However, adverse effects often lead to therapy interruption. This underlines the importance to find some predictive parameters of response in order to consider the possibility of a shorter time of antiviral treatment in the appearance of adverse effects without affecting the success of the therapy.
  
  
  OBJECTIVE
  We aimed to examine the HCVAg kinetics in the early phase of treatment and its predictive value of SVR in patients undergoing TPV/Peg-IFN/RBV treatment.
  
  
  METHODS
  Twenty-three patients infected by HCV genotype 1 (1a n=11; 1b n=12) were included in this prospective study.
  
  
  RESULTS
  At baseline the median Log of HCVAg concentration in RVR and EVR patients were 3.15 fmol/L and 3.45 fmol/L, respectively with no significant differences. The baseline median HCV-RNA to HCVAg ratio was 233.77, this ratio was significantly lower when measured on day 1 (27.52) and on day 6 (24.84) (p<0.001). The two-tailed Fisher's exact test indicated that the SVR response is statistically significantly different in patients with detected HCVAg at week1 compared to patients with no detectable HCVAg (p=0.05). The sensitivity, specificity, and negative and positive predictive values (NPV, PPV) were 53.8, 87.5, 53.8 and 87.5%, respectively. The area under the ROC curve was 0.71 at day T6, the best cut-off of 3 fmol/L when evaluated with the HCVAg plasma concentration at day T6.
  
  
  CONCLUSIONS
  Undetectable HCVAg in the early phase of TPV/Peg-IFN/RBV treatment could represent an important parameter for predicting SVR.
authors.affiliation: Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy. Electronic address: argarbuglia@iol.it.
authors.forename: Anna Rosa
authors.initials: AR
authors.lastname: Garbuglia
authors.affiliation: Clinical Department, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Lionetti
authors.affiliation: Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Lapa
authors.affiliation: Clinical Department, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Taibi
authors.affiliation: Clinical Department, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy.
authors.forename: Ubaldo
authors.initials: U
authors.lastname: Visco-Comandini
authors.affiliation: Clinical Department, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy.
authors.forename: Marzia
authors.initials: M
authors.lastname: Montalbano
authors.affiliation: Clinical Department, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy.
authors.forename: Gianpiero
authors.initials: G
authors.lastname: D'Offizi
authors.affiliation: Istituto per le Applicazioni del Calcolo (IAC) - CNR, Rome, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Castiglione
authors.affiliation: Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, Rome, Italy.
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Capobianchi
authors.affiliation: Istituto di Analisi dei Sistemi ed Informatica "Antonio Ruberti" (IASI) - CNR, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Paci
mesh_terms: D000368:Aged; D000956:Antigens, Viral / Q000097:blood*; D000998:Antiviral Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood*; D012372:ROC Curve; D012254:Ribavirin / Q000627:therapeutic use*; D012680:Sensitivity and Specificity; D014758:Viral Core Proteins / Q000276:immunology*
chemical_list: D000956:Antigens, Viral; D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D012367:RNA, Viral; D014758:Viral Core Proteins; D012254:Ribavirin; C486464:telaprevir
keywords: EVRearly virological response; HCVcore antigen; Hepatitis C virus; RVRrapid virological response; SVRsustained virological response; Telaprevir