1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry
Session: Poster Abstract Session: Clinical Trials
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • 1981_Reimer_German RWE_HCV Opioid_v.pres.pdf (635.4 kB)
  • Background: The coformulated direct-acting antivirals glecaprevir/pibrentasvir (G/P) are approved to treat chronic hepatitis C virus (HCV) genotype 1–6 infection. In clinical trials, G/P demonstrated high efficacy, but real-world data in patients on opioid substitution therapy (OST), a population for which antiviral treatment is critical for HCV elimination, are limited. Here we report the first real-world data on the effectiveness and safety of G/P for OST patients within the German Hepatitis C-Registry (DHC-R).

    Methods: The DHC-R is an ongoing, non-interventional, multicenter, prospective, monitored registry study. Data were collected between July 28, 2017 and February 9, 2018 from 104 sites in Germany. The analysis included adult HCV-infected patients who were treated with G/P according to the European Medicines Agency label. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12). Safety and tolerability were assessed in patients that completed treatment.

    Results: As of February 9, 2018, 638 patients had initiated on-label treatment with G/P and are included in the baseline analysis. Patients on OST comprised 26% (168/638) of the baseline population, of which most patients were treatment-naive, without cirrhosis and had HCV genotype 1a or 3. Among patients with available SVR12 data, 96% (27/28) of OST patients and 97% (66/68) of non-OST patients achieved SVR12. There were no virologic failures: of three early discontinuations, one OST patient was lost to follow-up and two non-OST patients discontinued treatment due to adverse events (AE). In the modified intention-to-treat population which excluded non-virologic failures, SVR12 was 100% for both OST and non-OST patients. The safety population included 321 patients in total. Among OST patients, 2% (2/84) experienced serious AEs (SAE) without any treatment discontinuations due to AE/SAE.

    Conclusion: In this real-world analysis, G/P treatment yielded favorable effectiveness and safety results in patients on OST. Updated data and SVR12 results will be presented.

    Jens Reimer, MD1,2, Albrecht Stoehr, MD3, Uwe Naumann, MD4, Gerlinde Teuber, MD5, Carsten Zamani, MD6, Stefan Mauss, MD7, Nazifa Qurishi, MD8, Kristina Lohmann, PhD9, Henning Kleine, PhD9, Andreas Pangerl, MD9 and Stefan Christensen, MD10, (1)Gesundheit Nord – Bremen Hospital Group, Bremen, Germany, (2)Center for Interdisciplinary Addiction Research University Medical Center Hamburg-Eppendorf, Hamburg, Germany, (3)Ifi-Institute for Interdisciplinary Medicine, Hamburg, Germany, (4)UBN/PRAXIS, Berlin, Germany, (5)Practice PD Dr. med., Frankfurt am Main, Germany, (6)Practice Dr. med., Hannover, Germany, (7)Center for HIV and Hepatogastroenterology, Düsseldorf, Germany, (8)Gemeinschaftspraxis Gotenring, Cologne, Germany, (9)AbbVie Inc., North Chicago, IL, (10)CIM Münster, Münster, Germany

    Disclosures:

    J. Reimer, AbbVie, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD: Board Member and Scientific Advisor , Educational grant and Speaker honorarium .

    A. Stoehr, AbbVie, Gilead, Janssen, MSD, ViiV: Consultant and Scientific Advisor , Consulting fee and Speaker honorarium .

    U. Naumann, AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Mundipharma, MSD, Roche, ViiV: Board Member , Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium .

    G. Teuber, : AbbVie, BMS, Janssen, Gilead, MSD: Consultant and Scientific Advisor , Consulting fee and Speaker honorarium .

    C. Zamani, AbbVie Inc: Board Member and Scientific Advisor , Consulting fee .

    S. Mauss, AbbVie, Gilead, Falk, Janssen, MSD: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium .

    N. Qurishi, AbbVie, Gilead, Janssen, MSD, ViiV, Mundipharma, Hexal: Consultant and Scientific Advisor , Consulting fee and Speaker honorarium .

    K. Lohmann, AbbVie Inc: Employee and Shareholder , Salary and Stock and/or options .

    H. Kleine, AbbVie Inc: Employee and Shareholder , Salary and Stock and/or options .

    A. Pangerl, AbbVie Inc: Employee and Shareholder , Salary and Stock and/or options .

    S. Christensen, AbbVie, Gilead, Indivior, Janssen-Cilag, MSD, ViiV: Consultant and Scientific Advisor , Consulting fee and Speaker honorarium .

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