Theme: Clinical Research Year: 2019
Background: People who use drugs (PWUD) with chronic hepatitis C virus (HCV) infection should be
prioritized for treatment given the increased risk of HCV transmission in this population. Anti-HCV
seroprevalence is 42–75% in injection drug users. Glecaprevir/pibrentasvir (G/P), an interferon-free,
ribavirin-free, fixed-dose direct-acting antiviral combination, is approved for treatment of adults
with chronic HCV genotype (GT) 1–6 infection. This pooled analysis aims to evaluate the real-world
effectiveness and safety of G/P in HCV-infected PWUD in ongoing post-marketing observational
studies.
Methods: Data were pooled from Austria, Belgium, France, Greece, Israel, Italy, Poland, and
Switzerland (13 November 2017–31 January 2019). Patients had chronic HCV GT1–6, without
cirrhosis or with compensated cirrhosis, and were treatment-naïve or -experienced. Patients
received G/P at the physician’s discretion. Only patients treated per SmPC were included in this
analysis. Recreational drug use was self-reported. Effectiveness was assessed as the percentage of
patients who achieved sustained virologic response at post-treatment Week 12 (SVR12). Safety was
assessed in patients who received ≥1 dose of G/P.
Results: 1276 patients received ≥1 dose of G/P, of whom 426 (33%) were PWUD. Of PWUD, 36% had
GT3, 85% were treatment-naïve, and 85% were non-cirrhotic. The most common recreational drugs
were heroin (58%) and cocaine (27%). The most common route was intravenous (69%). 2% were
coinfected with hepatitis B virus. 7% were coinfected with human immunodeficiency virus. Duration
of G/P treatment was 8 weeks in 81%, 12 weeks in 17%, and 16 weeks in 2%. The SVR12 rate was
98.6% (712/722; 8 virologic failures) overall and 98.1% (208/212; 3 virologic failures) in PWUD. No
HCV reinfections were reported. There were no G/P-related serious adverse events (AEs). AEs
leading to premature G/P discontinuation were rare (<1%).
Conclusion: G/P was well tolerated and highly effective in HCV-infected PWUD in the real world.
Disclosure of Interest Statement:
Rizzardini G: Paid consultant: AbbVie, Angelini, Bristol-Myers Squibb, Gilead, MSD, and ViiV;
Research funding through ASST Fatebenefratelli Sacco University Hospital: AbbVie, Gilead, MSD, and
ViiV.
Gschwantler M: Advisory board member and speaker: AbbVie, Gilead, Janssen, and MSD; Grants:
AbbVie, Gilead, and MSD.
Bourgeois S: Advisory board member and speakers bureau: AbbVie, Bristol-Myers Squibb, Gilead,
Janssen, and MSD.
Müllhaupt B: Advisory board member and speaker: AbbVie and Gilead; Grants: Gilead.
Mazur W: Lectures fee: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck, and Roche; Research
funding: AbbVie, Gilead, Merck, and Roche; Consultancy: AbbVie, Bristol-Myers Squibb, Gilead,
Janssen, Merck, and Roche.
Bondin M, Crown E, and Zhang ZZ: Employees of AbbVie, Inc. and may hold stock or stock options.
Veitsman E: Nothing to disclose.
Mimidis K: Advisory board member and speaker: AbbVie, Gilead, and MSD; Grants: AbbVie and
MSD.
Foucher J: Advisory board member and speaker: AbbVie, Gilead, Intercept, and MSD.
Acknowledgments: 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 Stephanie Grice, MSc, of
Fishawack Communications Ltd, funded by AbbVie.