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, MA, Van den Eynde, E, Navarro, J, Cifuentes Luna, Carmen, Murillas Angoiti, Javier, Veloso, S, Martinez-Rebollar, M, Guardiola, JM, Jou, A, Gomez-Sirvent, J. L, Cervantes, M, Pineda, JA, Lopez-Calvo, S, Carrero, A, Montes, ML, Deig, Elisabeth, Tapiz, A, Ruiz-Mesa, JD, Cruceta, A, de Lazzari, Ellsa, Mallolas, J
Tipo de recurso: artículo
Fecha de publicación:2016
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/20233
Acceso en línea:http://hdl.handle.net/20.500.12105/20233
Access Level:acceso abierto
Palabra clave:PEG-IFN/RBV plus BOC therapy
HIV-HCV experienced patients
HCV genotype 1
Re-treatment
Prolina
Resultado del Tratamiento
Coinfección
Polietilenglicoles
Interferón-alfa
Femenino
Infecciones por VIH
Masculino
Quimioterapia Combinada
Hepatitis C
Humanos
Persona de Mediana Edad
Estudios Prospectivos
Genotipo
Proteínas Recombinantes
Proteínas no Estructurales Virales
Antivirales
Adulto
Ribavirina
Hepacivirus
Retratamiento
España
Viral Nonstructural Proteins
Genotype
Retreatment
Polyethylene Glycols
Spain
Adult
Antiviral Agents
Humans
Drug Therapy, Combination
Middle Aged
Recombinant Proteins
HIV Infections
Male
Prospective Studies
Female
Coinfection
Treatment Outcome
Proline
Interferon-alpha
Ribavirin
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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