Author: Christensen S, Stoehr A, Teuber G, Naumann U, Knechten H, Qurishi N, Pires dos Santos AG, Lohmann K, Reimer J

Theme: Clinical Research Year: 2019

Background: Glecaprevir/pibrentasvir (G/P) is approved to treat chronic hepatitis C virus (HCV)
infection. Real-world data on patient-reported outcomes (PROs) are limited in key subgroups for
achieving HCV elimination including patients on opioid substitution therapy (OST) and patients with
mental disorders or alcohol use disorder (AUD). We report real-world data on the effectiveness and
safety of G/P and PROs in these key subgroups within the German Hepatitis C-Registry (DHC-R).
Methods: The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational
cohort study. Data were collected 2 August 2017–20 January 2019 for patients treated with G/P onlabel. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12),
assessed in patients who received ≥1 dose of G/P. Safety and PROs were also assessed.
Results: Of 1698 patients, 439 (26%) were on OST, 247 (15%) had mental disorders, and 106 (6%)
had AUD. The majority were HCV treatment-naïve (89%) and without cirrhosis (93%). In the
intention-to-treat population, the SVR12 rate was: overall, 96.6% (964/998); OST, 94.4% (218/231);
mental disorders, 97.1% (136/140); AUD, 96.7% (58/60). Three patients had G/P-related serious
adverse events (AEs); 3 patients discontinued G/P due to AEs (nausea; diarrhea; vomiting). Patients
in these subgroups reported lower baseline SF-36 physical and mental component summary (PCS
and MCS) scores and greater improvements in these scores than patients without these
characteristics. The mean change in PCS and MCS scores from baseline to post-treatment week 12
was: overall (N=236), 1.6 and 4.7; OST (N=56), 1.8 and 6.1; mental disorders (N=40), 2.3 and 4.9;
AUD (N=22), 1.9 and −0.4.
Conclusion: In the real world, G/P treatment led to improvements in SF-36 component scores; the
greatest improvements were observed in patients on OST or patients with mental disorders,
suggesting these patients may benefit most from treatment. Updated data for effectiveness, safety,
and PROs will be presented.
Disclosure of Interest Statement:
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). Financial support of analysis and publication was provided by AbbVie. The German Hepatitis
C-Registry is financially supported by AbbVie Deutschland GmbH & Co. KG, Bristol-Myers Squibb
GmbH & Co. KGaA, Gilead Sciences GmbH, Janssen-Cilag GmbH, and MSD Sharp & Dohme GmbH, as
well as Roche Pharma AG (financial support until 2017-07-14).
S Christensen: Honoraria for Consulting or Speaking at Educational Events: AbbVie, Gilead, Indivior,
Janssen-Cilag, MSD, and ViiV.
A Stoehr: Speaker: AbbVie, Gilead, Janssen, and MSD; Advisor: AbbVie and ViiV.
G Teuber: Speaker: AbbVie, Gilead, and MSD; Advisory Board: AbbVie and Gilead.
U Naumann: Speaker/Advisory Board: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Mundipharma,
MSD, Roche, and ViiV.
H Knechten: Nothing to disclose.
N Qurishi: Speaker/Teacher: AbbVie, Gilead, Janssen, MSD, ViiV, Mundipharma, and Hexal.
K Lohmann and AG Santos dos Pires: Employees of AbbVie and may hold stock or options.
J Reimer: Speaker/Advisory Board/Unrestricted Educational Grant: AbbVie, Bristol-Myers Squibb,
Gilead, Janssen-Cilag, and MSD.
Acknowledgements: AbbVie sponsored the study, contributed to its design, and participated in the
collection, analysis, and interpretation of the data and in the writing, reviewing, and approval of the
abstract. All authors had access to relevant data, and participated in the writing, review, and
approval of the abstract. Medical writing support was provided by Brandy Menges, PhD, of
Fishawack Communications Ltd, funded by AbbVie.

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