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. (December 2016)

• Record Type: Journal Article
• Authors: Laguno, M.; Von Wichmann, M.A.; Van den Eynde, E.; Navarro, J.; Cifuentes, C.; 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, A.; Montes, M.L.; Deig, E.; Tapiz, A.; Ruiz-Mesa, J.D.; Cruceta, A.; de Lazzari, E.; Mallolas, J.
• Is Part Of: International journal of infectious diseases. Volume 53(2016:Dec.)
• Page Start: 46
• Page End: 51
• Publication Date: 2016-12
• Subjects: PEG-IFN/RBV + BOC therapy -- HIV–HCV experienced patients -- HCV genotype 1 -- Re-treatment; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2016.10.028
• Languages: English
• ISSNs: 1201-9712

Abstract

Summary: 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.