Safety and efficacy of an induction dose of pegylated interferon alpha-2a on early hepatitis C virus kinetics in HIV/HCV co-infected patients: The CORAL-1 multicentre pilot study

C. Tural, R. Solà, R. Rubio, M. Santín, R. Planas, C. Quereda, J. Berenguer, M. Montes-Ramírez, B. Clotet, Anna Salas, Angel Ballesteros, Daniel Fuster, Guillem Sirera, Antoni Jou, Ramon Planas, Bonaventura Clotet, C. Tural, Dolors Gimenez, J. Antoni Galeras, Carmen MarquezRicard Solà, Federico Pulido, R. Rubio, Pilar Robres, M. Santín, Ana Moreno, Carmen Quereda, Santiago Moreno, Pilar Miralles, Jaime Cosín, Juan Carlos López, Paloma Gijón, Matilde Sánchez-Conde, Juan Berenguer, Juan Gonzalez García, José Ramón Arribas, Alicia Lorenzo, Susana Hernández, Marisa Montes-Ramírez, Enrique Ortega, Miguel Angel Von Wichmann

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Abstract

To evaluate the safety and efficacy of an induction dose of pegylated interferon alpha 2a (IFN-α2a) on the 12-week hepatitis C virus (HCV) kinetics in human immunodeficiency virus (HIV) patients co-infected with HCV. One hundred sixteen HIV/HCV co-infected patients from nine hospitals in Spain were randomized to receive 270 μg/week of pegylated IFN-α2a for 4 weeks followed by 180 μg/week for 8 weeks or 180 μg/week for 12 weeks. Ribavirin was given at a daily dose of 1000 or 1200 mg. The main outcome measure was the percentage of patients achieving an HCV-RNA below 50 IU/mL or a decrease of 2 or more log10 at week 12 (early virologic response, EVR). HCV-RNA was measured at baseline, weekly, for the first 4 weeks and monthly thereafter. We observed no difference in the percentage of patients achieving an EVR between arms (on-treatment, 74% in both arms; intention-to-treat, 70% in the induction arm and 67% in the control arm), nor were there differences in the percentage achieving an undetectable HCV qualitative polymerase chain reaction at any time points or in the decrease in HCV-RNA from baseline. No differences were found between arms in the percentage of dropouts (8% in the whole study population). Our study failed to find a benefit of an induction dose of 270 μg/week of pegylated IFN-α2a for 4 weeks on the EVR in co-infected patients who are treatment naive. Despite the lack of benefit with this regimen, induction therapy with this schedule was safe and well tolerated in co-infected patients. © 2007 The Authors.
Original languageEnglish
Pages (from-to)704-713
JournalJournal of Viral Hepatitis
Volume14
Issue number10
DOIs
Publication statusPublished - 1 Oct 2007

Keywords

  • Early virologic response
  • HCV-RNA
  • HIV/HCV co-infected patients
  • Induction therapy
  • Pegylated IFN-α2a

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