2026-08-05T15:43:13Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/202332024-11-28T17:41:58Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16961col_20.500.12105_16967

00925njm 22002777a 4500 dc Laguno, M author Von Wichmann, MA author Van den Eynde, E author Navarro, J author Cifuentes Luna, Carmen author Murillas Angoiti, Javier author Veloso, S author Martinez-Rebollar, M author Guardiola, JM author Jou, A author Gomez-Sirvent, J. L author Cervantes, M author Pineda, JA author Lopez-Calvo, S author Carrero, A author Montes, ML author Deig, Elisabeth author Tapiz, A author Ruiz-Mesa, JD author Cruceta, A author de Lazzari, Ellsa author Mallolas, J author 2016-12 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. Laguno M, Von Wichmann MA, Van Den Eynde E, Navarro J, Cifuentes Luna C, Murillas Angoiti J, et al. 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. Int J Infect Dis. 2016 Dec;53:46-51. Epub 2016 Nov 1. 10.1016/j.ijid.2016.10.028 1878-3511 1201-9712 International Journal of Infectious Diseases http://hdl.handle.net/20.500.13003/17296 27815225 L613310152 2-s2.0-84997050481 http://hdl.handle.net/20.500.12105/20233 389516700011 PEG-IFN/RBV plus BOC therapy HIV-HCV experienced patients HCV genotype 1 Re-treatment 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