Sunday, January 29, 2017

Glecaprevir and Pibrentasvir for 12 Wks HCV Genotype 1 and Prior Direct-acting Antiviral Treatment

Viral Hepatitis Glecaprevir and Pibrentasvir for 12 Weeks for HCV Genotype 1 Infection and Prior Direct-acting Antiviral Treatment
Fred Poordad, Franco Felizarta, Armen Asatryan, Mark S. Sulkowski, Robert W. Reindollar, Charles S. Landis, Stuart C. Gordon, Steven L. Flamm, Michael W. Fried, David E. Bernstein, Chih-Wei Lin, Ran Liu, Sandra S. Lovell, Teresa I. Ng, Jens Kort, Federico J. Mensa

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record.

Accepted manuscript online: 27 January 2017

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Although direct-acting antiviral (DAA) therapies for chronic hepatitis C virus (HCV) infection have demonstrated high rates of sustained virologic response, virologic failure may still occur, potentially leading to the emergence of viral resistance, which can decrease the effectiveness of subsequent treatment. Treatment options for patients who failed previous DAA-containing regimens, particularly those with NS5A inhibitors, are limited, and remain an area of unmet medical need. This phase 2, open-label study (MAGELLAN-1) evaluated the efficacy and safety of glecaprevir (GLE) + pibrentasvir (PIB) ± ribavirin (RBV) in HCV genotype 1-infected patients with prior virologic failure to HCV DAA-containing therapy. A total of 50 non-cirrhotic patients were randomized to three arms: 200 mg GLE + 80 mg PIB (Arm A), 300 mg GLE + 120 mg PIB with 800 mg once-daily RBV (Arm B), or 300 mg GLE + 120 mg PIB without RBV (Arm C). By intent-to-treat analysis, sustained virologic response at post-treatment week 12 (SVR12) was achieved in 100% (6/6, 95% CI 61 – 100), 95% (21/22, 95% CI 78 – 99), and 86% (19/22, 95% CI 67 – 95) of patients in Arms A, B, and C, respectively. Virologic failure occurred in no patients in Arm A, and 1 patient each in Arms B and C (two patients lost to follow-up in Arm C). The majority of adverse events were mild in severity; no serious adverse events related to study drug and no relevant laboratory abnormalities in alanine aminotransferase, total bilirubin, or hemoglobin, were observed. Conclusion: The combination of GLE and PIB was highly efficacious and well-tolerated in patients with HCV GT1 infection and prior failure to DAA-containing therapy; RBV coadministration did not improve efficacy. This article is protected by copyright. All rights reserved.
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