High efficacy and safety of triple therapy in HCV genotype 1 and moderate fibrosis: a multicenter study of clinical practice in Spain



Título del documento: High efficacy and safety of triple therapy in HCV genotype 1 and moderate fibrosis: a multicenter study of clinical practice in Spain
Revista: Annals of hepatology
Base de datos: PERIÓDICA
Número de sistema: 000411747
ISSN: 1665-2681
Autores: 1
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Instituciones: 1Hospital Universitario Marqués de Valdecilla, Santander, Cantabria. España
2Hospital General Valencia, Valencia. España
3Generalitat Valenciana, Hospital La Fe, Valencia. España
4Hospital Universitario del Mar, Barcelona. España
5Universidad de Valencia, Hospital Clínico Universitario, Valencia. España
6Hospital Universitario Trías y Pujol, Badalona, Barcelona. España
7Hospital Carlos III, Madrid. España
8Hospital Universitario Puerta Hierro, Madrid. España
9Hospital Toledo, Toledo, Castilla-La Mancha. España
10Hospital Clinic, Barcelona. España
11Hospital del Tajo, Aranjuez, Madrid. España
12Hospital San Pedro, Logroño, La Rioja. España
13Hospital 12 de Octubre, Madrid. España
14Hospital Universitari de Girona Doctor Josep Trueta, Gerona. España
15Hospital Universitario Vall d'Hebron, Barcelona. España
16Hospital Universitario Valme, Sevilla, Andalucía. España
17Hospital Universitario de Burgos, Burgos. España
18Hospital Universitario de Alcorcón, Alcorcón, Madrid. España
19Complejo Asistencial Universitario León, León, Castilla y León. España
20Hospital Universitario Rio Hortega, Valladolid. España
21Hospital Universitario Virgen del Rocío, Sevilla, Andalucía. España
22Hospital Comarcal de Laredo, Laredo, Cantabria. España
23Hospital Universitario de Canarias, Tenerife, Santa Cruz de Tenerife. España
Año:
Periodo: Jul-Ago
Volumen: 14
Número: 4
Paginación: 477-486
País: México
Idioma: Inglés
Tipo de documento: Artículo
Enfoque: Analítico, descriptivo
Resumen en inglés 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
Disciplinas: Medicina
Palabras clave: Farmacología,
Gastroenterología,
Hepatitis C,
Fibrosis hepática,
Telaprevir,
Respuesta viral
Keyword: Medicine,
Gastroenterology,
Pharmacology,
Hepatitis C,
Liver fibrosis,
Telaprevir,
Viral response
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