Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study

Geert Robaeys, Stefan Christensen, Damien Lucidarme, Amber Arain, Philip Bruggmann, Jan Kunkel, Sofia Keim, Martin Jäkel, Ralph DeMasi, Chris Liu, Isabelle Lonjon-Domanec, Graham R Foster, Geert Robaeys, Stefan Christensen, Damien Lucidarme, Amber Arain, Philip Bruggmann, Jan Kunkel, Sofia Keim, Martin Jäkel, Ralph DeMasi, Chris Liu, Isabelle Lonjon-Domanec, Graham R Foster

Abstract

Introduction: People who inject drugs represent an under-treated chronic hepatitis C virus (HCV)-infected patient population.

Methods: INTEGRATE was a prospective, observational study investigating the effectiveness, safety, and adherence in routine clinical practice to telaprevir in combination with peg-interferon and ribavirin (Peg-IFN/RBV) in patients with history of injecting drug use chronically infected with genotype 1 HCV.

Results: A total of 46 patients were enrolled and included in the intent-to-treat (ITT) population. Among heroin and/or cocaine users (n = 37; 80%), 22% reported use in the past month; 74% (34/46) of patients were on opioid substitution therapy in the pre-treatment phase, and 43% (20/46) discontinued HCV treatment prematurely. Sustained virologic response rate was 54% (25/46) in the ITT population and 74% (25/34) in the per protocol (evaluable-for-effectiveness) population. The main reason for failure in the ITT analysis was loss to follow-up (n = 8; 17%). Adverse events occurred in 91% (42/46) of patients. Mean patient-reported adherence to study drugs was >89% at Week 4, Week 12 and end of treatment.

Conclusion: Despite a high rate of treatment discontinuation (including loss to follow-up), self-reported adherence to treatment was good and virologic cure rates were similar to those reported in large real-world cohorts. Our findings suggest that people with a history of injecting drug use should be considered for treatment of chronic HCV infection, and highlight the need for improvements in patient support to boost retention in care and, in turn, help to prevent reinfection and transmission.

Clinical trial registration: Clinicaltrials.gov identifier, NCT01980290.

Funding: Janssen Pharmaceuticals.

Keywords: HCV; Injection drug users; Opioid substitution therapy; PWID; Retention in care; Telaprevir.

Figures

Fig. 1
Fig. 1
Patient disposition. Asterisk ITT population is defined as all patients treated with telaprevir and having at least one post-baseline effectiveness or safety assessment. Of the 49 patients who were treated, 46 had post-baseline assessments and were included in the ITT population. AE adverse event, ITT intent-to-treat, LTFU lost to follow-up

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Source: PubMed

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