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

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ID: 198167
2016
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Abstract
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.
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Authors M. Laguno, M.A. Von Wichmann, E. Van den Eynde, J. Navarro, C. Cifuentes, J. Murillas, S. Veloso, M. Martínez-Rebollar, J.M. Guardiola, A. Jou, J.L. Gómez-Sirvent, M. Cervantes, J.A. Pineda, S. López-Calvo, A. Carrero, M.L. Montes, E. Deig, A. Tapiz, J.D. Ruiz-Mesa, A. Cruceta, E. de Lazzari, J. Mallolas
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Journal israel journal of chemistry
Year 2016
DOI
10.1016/j.ijid.2016.10.028
URL
http://www.sciencedirect.com/science/article/pii/S1201971216312127
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