Individualized treatment of genotype 1 naïve patients: an Italian multicenter field practice experience

• Published in: PloS one Vol. 9; no. 10; p. e110284
• Main Authors: Mangia, Alessandra, Cenderello, Giovanni, Orlandini, Alessandra, Piazzolla, Valeria, Picciotto, Antonio, Zuin, Massimo, Ciancio, Alessia, Brancaccio, Giuseppina, Forte, Paolo, Carretta, Vito, Zignego, Anna Linda, Minerva, Nicola, Brindicci, Gaetano, Marignani, Massimo, Baroni, Gianluca Svegliati, Bertino, Gaetano, Cuccorese, Giuseppe, Mottola, Leonardo, Ripoli, Maria, Pirisi, Mario
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 23.10.2014; Public Library of Science (PLoS)
• Subjects: Anemia; Body mass; Body mass index; Body size; Decision Making; Drug Therapy, Combination; Female; Gastroenterology; Genetic Association Studies; Genotype; Genotype & phenotype; Genotypes; Hepacivirus - genetics; Hepatitis; Hepatitis C; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - genetics; Hepatitis C, Chronic - virology; Hepatology; Hospitals; Humans; Infections; Infectious diseases; Interferon; Interferons; Interleukins - genetics; Internal medicine; Italy; Liver; Liver cirrhosis; Liver diseases; Male; Medicine; Medicine and Health Sciences; Middle Aged; Oligopeptides - therapeutic use; Patients; Precision Medicine; Proline - analogs & derivatives; Proline - therapeutic use; Therapy; Treatment Outcome; Viruses; Italy; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0110284

Triple therapy including Telaprevir or Boceprevir still represents in many European countries the standard of care for patients with Hepatitis C Virus genotype 1 infection. The number of patients who received this treatment resulted generally lower than expected. We investigated, among naïve patients, number and characteristics of treatment candidates who were started on triple or dual therapy in comparison to those who were deferred. 621 naïve treatment candidates were prospectively evaluated at each center. Factors associated with decision to defer or treat with dual or triple therapy were investigated by univariate and multivariate analyses. Rates of Sustained Virological Response and safety profile were analysed. Of candidates to treatment, 33% did not received it. It was mostly due to high risk of Interferon-induced decompensation. Of 397 patients who were started on treatment, 266 (67%) received triple, 131 dual. Among patient receiving treatment, unfavorable IL28B, severe liver damage and higher albumin were independently associated with the physician decision to administer triple therapy. Sustained Virological Response after dual therapy was 66.4%, after triple 73.7% (p = 0.14). 142 patients received Telaprevir. The choice of Telaprevir-based therapy was associated with higher Body Mass Index and advanced liver disease. Sustained Virological Response rates were 71.1% after Telaprevir and 76.6% after Boceprevir. Individualizing treatment with available regimens allows to maximize Sustained Virological Response and to reduce the number of patients who remain untreated. High proportion of patients with severe liver damage urgently need Interferon free treatment.