2. Opportunistic Treatment of Hepatitis C Virus Infection: A pragmatic stepped-wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs (OPPORTUNI-C)

Thursday, 24 November, 2022 - 18:30 to 19:30


Aim: Hospitalizations may represent opportunities to engage people who inject drugs (PWID) in HCV-care. We present the protocol and preliminary results from an ongoing trial of immediate versus outpatient HCV-treatment initiation among hospitalized PWID (ClinicalTrials.gov, NCT04220645).

Design: Pragmatic stepped-wedge cluster-randomized trial. Intervention: Non-invasive liver disease assessment and prompt pan-genotypic DAA treatment with individualized follow-up. Standard of care: Referral to outpatient care at discharge. Methods: A pragmatic clinical trial approach is used to mimic usual clinical practice as closely as possible and enhance external validity. The stepped-wedge design involves a sequential rollout of the intervention, in which seven participating clusters will be randomized from standard of care to intervention in a stepwise manner. Data is collected from electronic patient files.The trial will include approximately 220 HCV-RNA positive individuals recruited from departments of internal medicine, addiction medicine, and psychiatry at three hospitals in Oslo. Primary outcome: Treatment completion, defined as dispensing of the final prescribed DAA-package from the pharmacy within 6 months after inclusion. Secondary outcomes: Treatment uptake, virologic response, reinfection incidence, and resistanceassociated substitutions.

Results: The first study participant was included on October 1st 2019, and inclusion was completed on December 31st 2021. A total of 218 participants were included, 108 under control conditions and 110 under intervention conditions. Preliminary results will be presented.

Conclusions: Representing a novel model of care suited to reach and engage PWID in HCV-care, this study will inform HCV elimination efforts locally and internationally. If the model proves efficacious and feasible, it should be considered for broader implementation.


Presentation files

24 115 1830 Olav Dalgard.pdf3.9 MBDownload



Part of session