Opportunistic Treatment of Hepatitis C Infection Among Hospitalised People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomised Trial

Background: People who inject drugs (PWID) are a priority population for hepatitis C virus (HCV) treatment. Hospitalisations for drug-related harms may represent opportunities to engage PWID in HCV testing and treatment. We aimed to evaluate the efficacy of an immediate HCV treatment strategy among hospitalised PWID.Methods: We performed a pragmatic, stepped wedge cluster randomised trial recruiting HCV RNA positive individuals admitted for inpatient care in departments of internal medicine, addiction medicine, and psychiatry at three hospitals in Oslo, Norway. Seven departments (clusters) were sequentially randomised to change from standard of care to intervention conditions over eight time periods. The intervention involved immediate HCV treatment initiation with individualized follow-up. Standard of care was a referral to outpatient care at discharge. The primary outcome was treatment completion, defined as dispensing the final package of the prescribed treatment within six months after enrolment. Findings: A total of 200 participants were enrolled between 1 October 2019 and 31 December 2021. The mean age was 47·4 years, 72·5% were male, 60·5% had injected drugs in the past three months, and 20·4% had liver cirrhosis. The primary outcome was accomplished by 67 of 98 (68·4%; 95% CI 58·2-77·4) during intervention conditions and by 36 of 102 (35·3%; 95% CI 26·1-45·4) during control conditions (absolute increase 33·1%; 95% CI 20·0%-46·2%). Adjusted for secular trends and cluster effects, the intervention was superior to standard of care in terms of treatment completion (aOR 4·8; 95% CI 1·8-12·8; p=0·0017) and time to treatment initiation (aHR 3·5; 95% CI 2·3-5·3; p<0·0001).Interpretation: In this randomised trial, an opportunistic test-and-treat approach to HCV infection was superior to standard of care among hospitalised PWID. The model of care should be considered for broader implementation to reach the World Health Organization HCV elimination targets.Trial Registration Details: The study is registered with ClinicalTrials.gov (NCT04220645).Funding Information: The trial was funded by a research grant from the Southern and Eastern Norway Regional Health Authority (grant number 2020011).Declaration of Interests: Håvard Midgard has received advisory board fees and lecture fees from Gilead Sciences, MSD, and Abbvie. Olav Dalgard has received advisory board fees and lecture fees from Gilead Sciences, MSD, and AbbVie, and research funding from MSD and Abbvie. Ronny Bjørnestad has received funding from Abbvie. The other authors report no conflicts of interest.Ethics Approval Statement: The study was approved by the Regional Committee for Medical Research Ethics in Norway on 3 March 2019 (reference number 2019-128). The study was conducted according to the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice guidelines. Written, informed consent was obtained from all participants.