title: High efficacy and safety of triple therapy in HCV genotype 1 and moderate fibrosis: a multicenter study of clinical practice in Spain.
abstract: OBJECTIVE
  Telaprevir-based therapy (TBT) has been extensively evaluated in clinical trials. So we designed a study to compare the efficacy and safety of TBT between patients with moderate fibrosis and those suffering from advanced fibrosis in clinical practice. A multicenter observational and ambispective study was conducted. It included 582 patients with chronic hepatitis C genotype 1, 214 with fibrosis F2, and 368 with F3/F4 (F3: 148; F4: 220).
  
  
  RESULTS
  The mean patient age was 55 years, 67% male. Type of prior response was 22% naïve, 57% relapsers, and 21% partial/null responders, 69% had high viral load (> 800,000 IU/mL). HCV genotypes were 1a (19%), 1b (69%), and 1 (12%), respectively. Sixty-five percent were non-CC IL28B genotype. Week-12 sustained virologic response (SVR12) was significantly higher among F2-naïve patients (78%) compared with F3/F4-naïve patients (60%; p = 0.039) and among F2 non-responders (67%) compared with F3/F4 non-responders (42%; p = 0.014). SVR12 among relapsers was remarkably high in both groups (F2:89% vs. F3/F4:78%). Severe anemia and thrombocytopenia were more frequent among patients with F3/F4 than those with F2 (p < 0.01). Overall, 132 patients (22%) discontinued treatment: 58 due to adverse effects, 42 due to the stopping-rule, and 32 due to breakthrough. Premature discontinuation was more frequent among patients with F3/F4 (p = 0.028), especially due to breakthrough (p < 0.001).
  
  
  CONCLUSIONS
  This multicenter study demonstrates high efficacy and an acceptable safety profile with regard to TBT in F2-patients in clinical practice.
authors.affiliation: Hospital Universitario Marqués de Valdecilla and IDIVAL. Santander. Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Crespo
authors.affiliation: Hospital General Valencia. Spain.
authors.forename: Moisés
authors.initials: M
authors.lastname: Diago
authors.affiliation: Hospital Universitario Marqués de Valdecilla and IDIVAL. Santander. Spain.
authors.forename: Joaquín
authors.initials: J
authors.lastname: Cabezas
authors.affiliation: Hospital La Fé, University of Valencia and CIBERehd. Spain.
authors.forename: Marina
authors.initials: M
authors.lastname: Berenguer
authors.affiliation: Hospital Universitario del Mar. Barcelona. Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Broquetas
authors.affiliation: Hospital Clínico Universitario-Universidad de Valencia. Valencia. Spain.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Serra
authors.affiliation: Hospital Universitario Trías y Pujol and CIBERehd. Badalona. Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Morillas
authors.affiliation: Hospital Carlos III and CIBERehd. Madrid. Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: García-Samaniego
authors.affiliation: Hospital Universitario Puerta Hierro. Madrid. Spain.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Calleja
authors.affiliation: Hospital Toledo. Spain.
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Sánchez
authors.affiliation: Hospital Clinic, IDIBAPS and CIBERehd. Barcelona. Spain.
authors.forename: Sabela
authors.initials: S
authors.lastname: Lens
authors.affiliation: Hospital del Tajo, Aranjuez, Madrid. Spain.
authors.forename: Susana
authors.initials: S
authors.lastname: Soto-Fernández
authors.affiliation: Hospital San Pedro, Logroño. Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Sacristán
authors.affiliation: Hospital 12 de Octubre. Madrid. Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Fernández
authors.affiliation: Hospital Universitario Girona Dr. Josep Trueta. Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: López-Núñez
authors.affiliation: Hospital Universitario del Vall d'Hebrón and CIEBRehd. Barcelona. Spain.
authors.forename: María
authors.initials: M
authors.lastname: Buti
authors.affiliation: Hospital Universitario Valme and CIBERehd. Sevilla. Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero-Gómez
authors.affiliation: Hospital Universitario de Burgos. Spain.
authors.forename: Federico
authors.initials: F
authors.lastname: Sáez-Royuela
authors.affiliation: Hospital Universitario de Alcorcón. Spain.
authors.forename: Conrado
authors.initials: C
authors.lastname: Fernández
authors.affiliation: Complejo Asistencial Universitario León. Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Jorquera
authors.affiliation: Hospital Universitario Rio Hortega. Valladolid. Spain.
authors.forename: Gloria
authors.initials: G
authors.lastname: Sánchez-Antolín
authors.affiliation: Hospital Universitario Virgen del Rocío. Sevilla. Spain.
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Pascasio
authors.affiliation: Hospital Comarcal de Laredo. Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Cuadrado
authors.affiliation: Hospital Universitario de Canarias. Tenerife. Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Hernández-Guerra
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics / Q000254:growth & development; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007372:Interferons; D007378:Interleukins / Q000235:genetics; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D012307:Risk Factors; D012720:Severity of Illness Index; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult; D000095022:Interferon Lambda
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D007372:Interferons; D007378:Interleukins; D009842:Oligopeptides; D012367:RNA, Viral; C000624353:interferon-lambda, human; D000095022:Interferon Lambda; C486464:telaprevir