• José-Luis Calleja, Javier García-Samaniego, Belén Ruiz-Antorán, María Trapero, Rosa Morillas, Juan de la Revilla, José Carlos Erdozaín, María-Dolores Espinosa, Dolores Suárez, Ricard Solá, Manuel Romero-Gómez, Fernando Baños, Marco-Antonio Alvarez, and Management of HCV Infection and Normal Transaminases Spanish Study Group.
• Department of Gastroenterology and Hepatology, University Hospital Puerta de Hierro Mahadahonda Madrid, Spain. joseluis.calleja@uam.es
• J. Gastroenterol. Hepatol. 2012 Nov 1;27(11):1705-10.

Background And AimTo 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.MethodsPatients 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.ResultsA 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.ConclusionsOur 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.© 2012 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

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