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-α2a/ribavirin (PEG-IFN/RBV) in the retreatment of HIV–HCV co-infected patients with HCV genotype 1. M...

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Detalhes bibliográficos
Autores: Laguno, M., Von Wichmann, M. A., Van den Eynde, E., Navarro, J., Cifuentes, Carmen, Murillas, J., Veloso, S., Martínez-Rebollar, M., Guardiola, J.M., Jou, A., Gómez-Sirvent, J.L., Cervantes, M., Pineda, J.A., López-Calvo, S., Carrero, Ana, Montes, M.L., Deig, E., Tapiz, A., Ruiz-Mesa, J.D., Cruceta, A., de Lazzari, E., Mallolas, Josep
Formato: artículo
Fecha de publicación:2016
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:20.500.12328/2628
Acesso em linha:http://hdl.handle.net/20.500.12328/2628
https://dx.doi.org/10.1016/j.ijid.2016.10.028
Access Level:acceso abierto
Palavra-chave:Teràpia PEG-IFN
RBV + BOC
Pacients
VIH-VHC
Genotip 1
Inhibidors orals
Hepatitis C
Boceprevir
Proteasa
Terapia PEG-IFN
Pacientes
Genotipo 1
Inhibidores orales
Peptidasas
PEG-IFN therapy
Patients
Genotype 1
Oral inhibitors
Protease
61
616.9
Descrição
Resumo: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-α2a/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 interferon-free therapies are not available yet.