Boceprevir plus pegylated interferon/ribavirin to re-treat hepatitis C virus genotype 1 in HIV-HCV co-infected patients: final results of the Spanish BOC HIV-HCV Study

Introduction: Boceprevir (BOC) was one of the first oral inhibitors of hepatitis C virus (HCV) NS3 protease to be developed. This study assessed the safety and efficacy of BOC + pegylated interferon-alpha 2a/ribavirin (PEG-IFN/RBV) in the retreatment of HIV-HCV co-infected patients with HCV genotype...

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Detalles Bibliográficos
Autores: Laguno, M., Von Wichmann, M. A., Van den Eynde, Eva, Navarro, J., Cifuentes Luna, Carmen, Murillas Angoiti, Javier, Veloso, Sergio, Martinez-Rebollar, M., Guardiola, J. M., Jou, A., Gomez-Sirvent, J. L., Cervantes, Manuel, Pineda, J. A., Lopez-Calvo, S., Carrero-Planells, Alba, Montes, M. L., Deig, Elisabeth, Tapiz, A., Ruiz-Mesa, J. D., Cruceta, A., de Lazzari, Elisa, Mallolas, J.
Tipo de recurso: artículo
Fecha de publicación:2016
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/17296
Acceso en línea:https://hdl.handle.net/20.500.13003/17296
Access Level:acceso abierto
Palabra clave:Interferon-alpha
Proline
Treatment Outcome
Coinfection
Female
Prospective Studies
Male
HIV Infections
Recombinant Proteins
Middle Aged
Drug Therapy, Combination
Humans
Hepatitis C
Antiviral Agents
Adult
Spain
Polyethylene Glycols
Retreatment
Hepacivirus
Genotype
Viral Nonstructural Proteins
Ribavirin
España
Humanos
Persona de Mediana Edad
Estudios Prospectivos
Genotipo
Proteínas Recombinantes
Proteínas no Estructurales Virales
Antivirales
Adulto
Prolina
Resultado del Tratamiento
Coinfección
Polietilenglicoles
Interferón-alfa
Femenino
Infecciones por VIH
Masculino
Quimioterapia Combinada
Ribavirina
Retratamiento
PEG-IFN/RBV plus BOC therapy
HIV-HCV experienced patients
HCV genotype 1
Re-treatment
Descripción
Sumario:Introduction: Boceprevir (BOC) was one of the first oral inhibitors of hepatitis C virus (HCV) NS3 protease to be developed. This study assessed the safety and efficacy of BOC + pegylated interferon-alpha 2a/ribavirin (PEG-IFN/RBV) in the retreatment of HIV-HCV co-infected patients with HCV genotype 1. Methods: This was a phase III prospective trial. HIV-HCV (genotype 1) co-infected patients from 16 hospitals in Spain were included. These patients received 4 weeks of PEG-IFN/RBV (lead-in), followed by response-guided therapy with PEG-IFN/RBV plus BOC (a fixed 44 weeks was indicated in the case of cirrhosis). The primary endpoint was the sustained virological response (SVR) rate at 24 weeks post-treatment. Efficacy and safety were evaluated in all patients who received at least one dose of the study drug. Results: From June 2013 to April 2014, 102 patients were enrolled, 98 of whom received at least one treatment dose. Seventy-three percent were male, 34% were cirrhotic, 23% had IL28b CC, 65% had genotype 1a, and 41% were previous null responders. The overall SVR rate was 67%. Previous null-responders and cirrhotic patients had lower SVR rates (57% and 51%, respectively). Seventy-six patients (78%) completed the therapy scheme; the most common reasons for discontinuation were lack of response at week 12 (12 patients) and adverse events (six patients). Conclusions: Response-guided therapy with BOC in combination with PEG-IFN/RBV led to an overall SVR rate of 67%, but an SVR rate of only 51% in patients with cirrhosis. The therapy was generally well tolerated. Although the current standards of care do not include BOC + PEG-IFN/RBV, the authors believe that this combination can be beneficial in situations where new HCV direct antiviral agent interferonfree therapies are not available yet.

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