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

Jose L. Calleja, Juan M. Pascasio, Belén Ruiz-Antorán, Francisco Gea, Rafael Bárcena, Juan R. Larrubia, Ramón Pérez-Álvarez, Jose M. Sousa, Manuel Romero-Gómez, Ricard Solá, Juan de la Revilla, Javier Crespo, Jose M. Navarro, Juan I. Arenas, Manuel Delgado, Conrado M. Fernández-Rodríguez, Ramon Planas, Maria Buti, Xavier Forns, AntónArenas, Bárcena, Calleja, Castellote, Castillo, Castro-Iglesias, Cuenca-Morón, Delgado, Erdozain, Fernández, Ferrer, Forns, Garcia-Bengoechea, García-Hoz, García-Samaniego, Gea, Gómez-García, González, Crespo, Ladero-Quesada, Larrubia-Marfil, Lens, Manzano, Martínez-Sierra, Martínez, Miguel, Molina, Monge, Muñoz, Narváez, Navarro-Jarabo, Núñez, Olveira, Pascasio, Planas, Portu, Pérez-Álvarez, de la Revilla, Rodado, Romero, Ruiz-Antorán, Ryan, Isabel Salcedo, Sánchez-Tapias, Serra, Solá, Sousa-Martin, Torras, Vergara

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16 Citations (Scopus)

Abstract

© 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.
Original languageEnglish
Pages (from-to)90-100
JournalLiver International
Volume35
Issue number1
DOIs
Publication statusPublished - 1 Jan 2015

Keywords

  • Boceprevir
  • Compassionate use
  • Hepatitis C
  • Safety and efficacy
  • Severe fibrosis

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    Calleja, J. L., Pascasio, J. M., Ruiz-Antorán, B., Gea, F., Bárcena, R., Larrubia, J. R., Pérez-Álvarez, R., Sousa, J. M., Romero-Gómez, M., Solá, R., de la Revilla, J., Crespo, J., Navarro, J. M., Arenas, J. I., Delgado, M., Fernández-Rodríguez, C. M., Planas, R., Buti, M., Forns, X., ... Vergara (2015). 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. Liver International, 35(1), 90-100. https://doi.org/10.1111/liv.12656