Peginterferon alpha-2a and ribavirin in patients with hepatitis C virus genotype 1 infection with persistently normal alanine aminotransferase levels

Authors

  • José-Luis Calleja,

    Corresponding author
    1. Department of Gastroenterology and Hepatology, University Hospital Puerta de Hierro Mahadahonda Madrid, Spain
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  • Javier García-Samaniego,

    1. Liver Unit, Hospital Carlos III, CIBERehd, Spain
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  • Belén Ruiz-Antorán,

    1. Clinical Pharmacology Department, University Hospital Puerta de Hierro Mahadahonda Madrid, Spain
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  • María Trapero,

    1. Liver Unit, Department of Gastroenterology, University Hospital La Princesa, Institute of investigation La Princesa and CIBERehd, Spain
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  • Rosa Morillas,

    1. Liver Unit, CIBERehd, Department of Gastroenterology, Germans Trias i Pujol University Hospital, Badalona, Badalona, Spain
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  • Juan de la Revilla,

    1. Department of Gastroenterology and Hepatology, University Hospital Puerta de Hierro Mahadahonda Madrid, Spain
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  • José Carlos Erdozaín,

    1. Department of Gastroenterology, University Hospital “Infanta Sofía,” Madrid, Spain
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  • María-Dolores Espinosa,

    1. Department of Gastroenterology, University Hospital Virgen de las Nieves, Granada, Spain
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  • Dolores Suárez,

    1. Department of Internal Medicine, Liver Unit, Complejo Hospitalario Arquitecto Marcide, Ferrol, Spain
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  • Ricard Solá,

    1. Liver Unit, Department of Gastroenterology, Hospital del Mar, Barcelona, Spain
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  • Manuel Romero-Gómez,

    1. Liver Unit, Hospital Nuestra Señora de Valme, CIBERehd, Sevilla, Spain
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  • Fernando Baños,

    1. Department of Gastroenterology, Consorci Sanitari Integral, Hospital de L'Hospitalet, L'Hospitalet de Llobregat, Spain
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  • Marco-Antonio Álvarez,

    1. Department of Gastroenterology, Althaia, Xarxa Assistencial de Manresa, Manresa, Spain
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  • for the Management of HCV Infection and Normal Transaminases Spanish Study Group

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    • Management of HCV Infection and Normal Transaminases Spanish Study Group: Dr José Luis Calleja; Dra Belén Ruiz-Antorán; Dr J de la Revilla; Dr Javier García Samaniego; Dra Miriam Romero; Dra Angelica Moreno; Dra María Trapero; Dr Ramón Planas; Dra Rosa Ma Morillas; Dr José Carlos Erdozaín; Ma Dolores Espinosa; Dra Flor Nogueras; Dra Dolores Suárez; Dr Ricard Solá; Dra Lourdes Grande; Dr M. Romero-Gómez; Dr Fernando Baños; Dr Marco Antonio Álvarez; Dr José Antonio Pons; Dra Angeles Castro; Dr Javier Salmerón Escobar; Dr Luis Rodriguez; Dr Miguel Jiménez Pérez; Dra Mercedes Vergara Gómez; Dra Mireia Miguel Planas; Dra Emilia García; Dra María Moreno; Dr Francisco Jorquera; Dra Rosa Durández; Dr Senador Morán; Dra Pilar Castillo; Dr Pere Vaquer; Dra Lucía Bonet; Dra María Jesús Suárez; Dra Milagros Testillanc; Dr José Ma Navarro; Dr P. Moreno Mejías; Dr José Aguilar; Dr Santiago Tomé; Dr Esteban Otero; Dr Agustín Domínguez; Dr Jaime Enríquez; Dr Adolfo Gallego Moya; Dr Jordi Ortiz; Dr Jaume Boadas; Dra Mercè Roget; Dra Mercé Barenys De Lacha; Dr Oscar Núñez; Dr Javier Rodríguez Gil; Dr Vicente Torrente González; Dr Manuel Miras; Dra Sonia Blanco Sampascual; Dr José Manuel González; Dr Fermín Santalla Reciña; Dr Raúl Andrade; Dr Ramón Barniol; Dr Miguel Torres; Dr Juan Carlos Quer; Dra Silvia Montoliu; Dr Benjamín Polo y Dr Manuel García Bengoechea.


  • Authors' declaration of personal interests: Dr Calleja has received fees for serving as an advisory board member for Roche, Gilead, MSD and Janssen. Dr García-Samaniengo has received fees for serving as a speaker and/or consultant for Roche, Gilead, MSD, BMS and Boehringer. Dr Solá has received fees for serving as an advisory board member for Roche, Gilead, MSD and BMS. Dr Romero has received fees for serving as a consultant and an advisory board member for Roche, Janssen, MSD, BMS and Boehringer. Dr Ruiz-Antorán, Dr, Trapero, Dr Morillas, Dr de la Revilla, Dr Erdozaín, Dr Espinosa, Dr Suarez, Dr Baños and Dr Alvarez have declared not having any conflict of interest within the last 3 years which may arise from being named as an author on this manuscript.

Dr José-Luis Calleja, Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro Majadahonda, C/Manuel de Falla 1, 28222 Majadahonda, Madrid, Spain. Email: joseluis.calleja@uam.es

Abstract

Background and Aim:  To evaluate the efficacy and safety of peginterferon α-2a plus ribavirin at standard doses in patients with hepatitis C virus (HVC) genotype 1 infection with persistently normal alanine aminotransferase (ALT) levels.

Methods:  Patients aged 18 to 65 years were included in this observational, prospective study if they had evidence of a HCV genotype 1 infection. The serum HCV RNA concentration was determined at baseline and week 12. A qualitative HCV RNA test was performed at baseline and at weeks 48 and 72. Liver function tests were performed at each study visit. The primary efficacy measure was the sustained virological response in the intention-to-treat population. Logistic regression analyses were also performed to explore predictors of virological response.

Results:  A sustained virological response was observed in 100 of the 175 patients (57%). An early virological response and end-of-treatment response were seen in 159 patients (91%) and 133 patients (76%), respectively. Thirty-seven of the 122 evaluable patients for this outcome (30%) showed a rapid virological response. A higher viral load was a significant predictor for a lack of rapid virological response and lack of sustained virological response. There were not any unexpected safety or tolerability findings.

Conclusions:  Our study suggests that the efficacy of the combination of peginterferon α-2a and ribavirin in patients with HCV genotype 1 infection and normal ALT levels is at least similar to that reported in patients with elevated ALT levels.

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