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

Abstract

Background We aimed to evaluate the efficacy of opportunistic treatment of hepatitis C virus (HCV) infection among hospitalized people who inject drugs (PWID). Methods We performed a pragmatic, stepped wedge cluster randomized 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 were sequentially randomized to change from control conditions (standard of care referral to outpatient care) to intervention conditions (immediate treatment initiation). The primary outcome was treatment completion, defined as dispensing the final package of the prescribed treatment within six months after enrolment. Results A total of 200 HCV RNA positive individuals were enrolled between 1 October 2019 and 31 December 2021 (mean age 47.4 years, 72.5% male, 60.5% injected past 3 months, 20.4% cirrhosis). Treatment completion was accomplished by 67 of 98 (68.4% [95% confidence interval {CI}: 58.2–77.4]) during intervention conditions and by 36 of 102 (35.3% [95% CI: 26.1–45.4]) during control conditions (risk difference 33.1% [95% CI: 20.0–46.2]; risk ratio 1.9 [95% CI: 1.4–2.6]). The intervention was superior in terms of treatment completion (adjusted odds ratio [aOR] 4.8 [95% CI: 1.8–12.8]; P = .002) and time to treatment initiation (adjusted hazard ratio [aHR] 4.0 [95% CI: 2.5–6.3]; P < .001). Sustained virologic response was documented in 60 of 98 (61.2% [95% CI: 50.8–70.9]) during intervention and in 66 of 102 (64.7% [95% CI: 54.6–73.9]) during control conditions. Conclusions An opportunistic test-and-treat approach to HCV infection was superior to standard of care among hospitalized PWID. The model of care should be considered for broader implementation. Clinical Trials Registration. NCT04220645

Virologic Response and Reinfection Following HCV Treatment among Hospitalized People Who Inject Drugs: Follow-Up Data from the OPPORTUNI-C Trial

“…Collectively, the findings add weight to the conclusions from OPPORTUNI-C [ 36 ], corroborating the feasibility and efficacy of an opportunistic treatment model among hospitalized PWID. This is the first study to validate complete DAA dispensation as a correlate for SVR.…”

“…OPPORTUNI-C (ClinicalTrials.gov NCT04220645) was a pragmatic, open-label, multicenter, stepped wedge cluster randomized trial conducted between 1 October 2019 and 31 December 2021 in departments of internal medicine, addiction medicine, and psychiatry at three hospitals in Oslo, Norway [ 36 ]. The study enrolled 200 participants, 98 during intervention conditions (immediate treatment) and 102 during control conditions (standard of care outpatient treatment).…”

“…Baseline data, including sex, age, housing status, injecting drug use, OAT status, and stage of liver disease, was collected as part of the clinical trial [ 36 ]. Follow-up data were collected between 1 July 2022 and 8 August 2023.…”

“…Follow-up data were collected between 1 July 2022 and 8 August 2023. Data on DAA dispensations from the pharmacy were extracted retrospectively by reviewing the electronic patient files as previously described [ 36 ].…”

“…OPPORTUNI-C was a cluster randomized trial among hospitalized PWID demonstrating the superiority of opportunistic HCV treatment in terms of treatment completion and time to treatment initiation [ 36 ]. The study also documented SVR, but within a very limited time frame.…”