Effectiveness and Safety of Direct-Acting Antiviral Combination Therapies for Treatment of Hepatitis C Virus in Elderly Patients: Results from the German Hepatitis C Registry
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With the aging of the hepatitis C virus (HCV)-infected patient cohort and the availability of highly effective and tolerable treatment regimens, an increasing number of elderly patients are now eligible for HCV therapy. This study investigated clinical and epidemiologic characteristics of elderly HCV-infected patients as well as the effectiveness and safety of available therapies.
Patients were enrolled into the German Hepatitis C Registry (DHC-R), a prospective, multicenter, real-world cohort study. Patients were treated at the discretion of the physician, and data were collected by a web-based system.
Of 7133 patients who initiated treatment, 686 (9.6%) were > 70 years of age. In patients > 70 years, intent-to-treat (ITT) SVR12 was 92.6% (514/555) compared to 90.7% (4521/4985) in patients ≤ 70 years of age. Overall, adverse events (AEs) were reported in 374 (54.5%) and 3435 patients (53.3%) > 70 or ≤ 70 years of age; 7.6% (52) and 3.6% (235) in the respective age groups had a serious AE. Twenty-two (3.2%) and 62 (1.0%) of the patients > 70 or ≤ 70 years discontinued treatment due to AEs. Death was reported in 34 patients, of whom eight were > 70 years of age. Frequent comorbidities in patients > 70 years of age were cardiac disease, renal disease and diabetes. Psychiatric disorders, substance abuse and viral co-infection were more frequent in younger patients.
Direct-acting antiviral therapies were well tolerated in patients older than 70 years. SVR12 rates in the elderly patient group were similar to those observed in younger patients. Differences in the prevalence of comorbidities between age groups warrant individualized attention with respect to drug–drug interactions and therapy adherence.
The study was registered in the German Clinical Trials Register, DRKS-ID: DRKS00009717.
Data acquisition was conducted by DHC-R investigators. All authors made substantial contributions to the design of the analysis, writing, and/or interpretation of data in this publication. All authors critically revised the manuscript and approved this publication. All authors had access to all relevant data. Data were derived from the German Hepatitis C Registry (Deutsches Hepatitis C Register), a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland in cooperation with the Association of German Gastroenterologists in Private Practice (bng), with financial support from the German Center for Infection Research (DZIF) and the companies AbbVie Deutschland GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Gilead Sciences GmbH, Janssen-Cilag GmbH, MSD Sharp & Dohme GmbH as well as Roche Pharma AG (financial support until 2017-07-14). We thank all DHC-R investigators, study nurses and Leberstiftungs-GmbH Deutschland, in particular, Bianka Wiebner and Dr. Yvonne Serfert. Statistical analysis support was provided by Heike Pfeiffer-Vornkahl from e.factum GmbH (Butzbach, Germany).
Collaborators: Rainer Günther, Holger Hinrichsen, Renate Heyne, Johannes Roth, Tobias Goeser, Rainer Ullrich, Christine John, Wolf Peter Hofmann, Gerlinde Teuber, Hjördis Möller, Axel Baumgarten, Jeannette Schwenzer, Anita Pathil, Michael R. Kraus, Andreas Weber, Maria-Christina Jung, Guido Gerken, Christoph Antoni, Margareta Frank Doss, Andreas Schober, Martin Hoffstadt, Armand v. Lucadou, Hermann Steffens, Hartwig Klinker, Andreas Geier, Gerd Klausen, Peter Buggisch, Markus Cornberg, Christoph Sarrazin, Michael P. Manns, Claus Niederau, Ulla Protzer, Peter Schirmacher.
Compliance with Ethical Standards
Conflict of interest
GD: Speaker for AbbVie. TM: Consultancies: MERZ, AbbVie, MSD, Roche, BMS, Bayer, Intercept, and Gilead; speaker: MERZ; grants: Deutsche Forschungsgemeinschaft, Falk Foundation, and Intercept. JP: Grant/research support: BMS, Novartis, and Roche; clinical studies: AbbVie, Arrowhead, BMS, Eisai, Falk, Gilead, Hepatera, Hologic, Intercept, Janssen, Merck, MSD, Roche, Siemens, and Vertex; consultant/advisor: Abbott, AbbVie, Arrowhead, Assembly Pharma, BMS, Contravir, Gilead, GSK, Kedrion, Janssen, Merck, MSD, Novira, and Roche; sponsored lectures: Abbott, BMS, Boehringer, Gilead, Kedrion, Janssen, Merck, Merz, MSD, Novartis, and Roche. SM: Advisory committees or review panels: AbbVie, and MSD; speaker: AbbVie, Janssen, Gilead, and MSD. TZ: Received lecturer, consultant fees and/or travel support from AbbVie, BMS, Gilead, Janssen, MSD and Roche; grant: BMS. MM: Advisory committees: Bayer; speaker: Intercept and BMS; travel grants: AbbVie, Gilead, MSD, and Roche. KGS: Consultancies: AbbVie, Janssen, BMS, and MSD; speaker: Falk, AbbVie, Gilead, BMS, Janssen, Norgine, Merz, and MSD. TB: Speaker: AbbVie, Alexion, Bayer, BMS, Gilead, Intercept, Janssen, MSD/Merck, Merz, Novartis, Sirtex and Sequana Medical; grants: AbbVie, BMS, Gilead, Intercept, Janssen, MSD/Merck, Merz, Novartis, and Sequana Medical; adviser: AbbVie, Alexion, Bayer, BMS, Gilead, Intercept, Janssen, MSD/Merck, Merz, Novartis, and Sequana Medical. SZ: Consultancies/speaker for AbbVie, BMS, Gilead, Janssen, and Merck/MSD. DH: Advisor: Novartis, Gilead, BMS, Janssen, AbbVie, Roche, and MSD. KB: Speaker: MSD, Gilead, BMS and Roche. HW: Advisor: Falk, AbbVie, Novartis, Roche Diagnostics, Eiger, Janssen, GSK, Transgene, MSD, Roche, Gilead, Abbott, and BMS; consultancies: MyrGmbH; grants: Roche Diagnostics, Novartis, Gilead, Roche, Abbott, and MSD; speaker: AbbVie, Gilead, BMS, MSD, Novartis, and ITF. TMW: Consultancies/speaker for AbbVie, Bristol-Myers Squibb, Gilead, and Janssen.
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