Theme: Clinical Research Year: 2018
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.
Disclosure of Interest Statement:
Data were derived from the German Hepatitis C-Registry (Deutsches Hepatitis CRegister), 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, MSD Sharp &
Dohme GmbH as well as Roche Pharma AG (financial support until 2017-07-14).