TY - JOUR
T1 - Safety and efficacy of triple therapy with peginterferon, ribavirin and boceprevir within an early access programme in Spanish patients with hepatitis C genotype 1 with severe fibrosis: SVRw12 analysis
AU - Calleja, Jose L.
AU - Pascasio, Juan M.
AU - Ruiz-Antorán, Belén
AU - Gea, Francisco
AU - Bárcena, Rafael
AU - Larrubia, Juan R.
AU - Pérez-Álvarez, Ramón
AU - Sousa, Jose M.
AU - Romero-Gómez, Manuel
AU - Solá, Ricard
AU - de la Revilla, Juan
AU - Crespo, Javier
AU - Navarro, Jose M.
AU - Arenas, Juan I.
AU - Delgado, Manuel
AU - Fernández-Rodríguez, Conrado M.
AU - Planas, Ramon
AU - Buti, Maria
AU - Forns, Xavier
AU - Antón, null
AU - Arenas, null
AU - Bárcena, null
AU - Calleja, null
AU - Castellote, null
AU - Castillo, null
AU - Castro-Iglesias, null
AU - Cuenca-Morón, null
AU - Delgado, null
AU - Erdozain, null
AU - Fernández, null
AU - Ferrer, null
AU - Forns, null
AU - Garcia-Bengoechea, null
AU - García-Hoz, null
AU - García-Samaniego, null
AU - Gea, null
AU - Gómez-García, null
AU - González, null
AU - Crespo, null
AU - Ladero-Quesada, null
AU - Larrubia-Marfil, null
AU - Lens, null
AU - Manzano, null
AU - Martínez-Sierra, null
AU - Martínez, null
AU - Miguel, null
AU - Molina, null
AU - Monge, null
AU - Muñoz, null
AU - Narváez, null
AU - Navarro-Jarabo, null
AU - Núñez, null
AU - Olveira, null
AU - Pascasio, null
AU - Planas, null
AU - Portu, null
AU - Pérez-Álvarez, null
AU - de la Revilla, null
AU - Rodado, null
AU - Romero, null
AU - Ruiz-Antorán, null
AU - Ryan, null
AU - Salcedo, Isabel
AU - Sánchez-Tapias, null
AU - Serra, null
AU - Solá, null
AU - Sousa-Martin, null
AU - Torras, null
AU - Vergara, null
PY - 2015/1/1
Y1 - 2015/1/1
N2 - © 2014 John Wiley & Sons A/S. Background & Aims: The addition of protease inhibitors (PIs) changed the hepatitis C virus (HCV) treatment standards and improved sustained viral response (SVR) rates in patients with genotype 1 HCV infection. Methods: Prospective, multicentre, national registry that includes naïve and treatment-experienced patients with HCV genotype 1 infection, who had bridging fibrosis or cirrhosis and were treated with triple therapy (peginterferon alfa-2a or alfa-2b, ribavirin and boceprevir) as compassionate use, and in accordance with the Summary of Product Characteristics. Results: Most of the patients (68.2%) were male, with a mean age of 53 years, 75% (n = 128) had HCV 1b genotype and baseline viral load of 6.2 log. According to prior treatment, 20% of patients were treatment-naïve and 80% had received prior treatment. Approximately 36.5% of patients (n = 62) reported at least one serious adverse events (SAEs) (total SAEs = 103). The most common SAEs were neutropenia (57.6%), anaemia (47.6%) and grade 3 thrombopenia (25.9%). Patients with albumin <3.5 g/dl and bilirubin >2 mg/dl had an increased relative risk (greater than one-fold) for SAEs, including infections and hepatic decompensation. In the intent-to-treat analysis (n = 170), the overall percentage of patients with SVRw12 was 46.5%. In patients with 1 log decrease at week 4 (lead-in phase), the overall SVRw12 rate was 67.0%. In the patients initiating triple therapy with boceprevir (n = 139), the global response rate was 56.4%. In a multivariate analysis, an increased probability of achieving SVR was associated with response to prior treatment (relapsers), >1 log decrease in viral load in the lead-in phase and baseline albumin >3.5 g/dl. Conclusions: Triple therapy in patients with severe fibrosis/cirrhosis is associated with a higher rate of SAE and a lower rate in comparison with patients with mild disease. However, for patients with intact liver function, it could be considered as a treatment option, when other alternatives would not be available.
AB - © 2014 John Wiley & Sons A/S. Background & Aims: The addition of protease inhibitors (PIs) changed the hepatitis C virus (HCV) treatment standards and improved sustained viral response (SVR) rates in patients with genotype 1 HCV infection. Methods: Prospective, multicentre, national registry that includes naïve and treatment-experienced patients with HCV genotype 1 infection, who had bridging fibrosis or cirrhosis and were treated with triple therapy (peginterferon alfa-2a or alfa-2b, ribavirin and boceprevir) as compassionate use, and in accordance with the Summary of Product Characteristics. Results: Most of the patients (68.2%) were male, with a mean age of 53 years, 75% (n = 128) had HCV 1b genotype and baseline viral load of 6.2 log. According to prior treatment, 20% of patients were treatment-naïve and 80% had received prior treatment. Approximately 36.5% of patients (n = 62) reported at least one serious adverse events (SAEs) (total SAEs = 103). The most common SAEs were neutropenia (57.6%), anaemia (47.6%) and grade 3 thrombopenia (25.9%). Patients with albumin <3.5 g/dl and bilirubin >2 mg/dl had an increased relative risk (greater than one-fold) for SAEs, including infections and hepatic decompensation. In the intent-to-treat analysis (n = 170), the overall percentage of patients with SVRw12 was 46.5%. In patients with 1 log decrease at week 4 (lead-in phase), the overall SVRw12 rate was 67.0%. In the patients initiating triple therapy with boceprevir (n = 139), the global response rate was 56.4%. In a multivariate analysis, an increased probability of achieving SVR was associated with response to prior treatment (relapsers), >1 log decrease in viral load in the lead-in phase and baseline albumin >3.5 g/dl. Conclusions: Triple therapy in patients with severe fibrosis/cirrhosis is associated with a higher rate of SAE and a lower rate in comparison with patients with mild disease. However, for patients with intact liver function, it could be considered as a treatment option, when other alternatives would not be available.
KW - Boceprevir
KW - Compassionate use
KW - Hepatitis C
KW - Safety and efficacy
KW - Severe fibrosis
U2 - 10.1111/liv.12656
DO - 10.1111/liv.12656
M3 - Article
VL - 35
SP - 90
EP - 100
IS - 1
ER -
