OPPORTUNI-C
Trial question
What is the role of opportunistic treatment of HCV infection in hospitalized patients who inject drugs?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.7% female
72.3% male
N = 200
200 patients (55 female, 145 male).
Inclusion criteria: HCV RNA-positive patients admitted for inpatient care.
Key exclusion criteria: ongoing HCV infection treatment; pregnancy or lactation; no informed consent.
Interventions
N=98 immediate treatment initiation (immediate HCV assessment and treatment initiation during hospitalization or as soon as possible after discharge).
N=102 standard of care (outpatient HCV care following discharge in accordance with the established standard of care for hospitalized patients).
Primary outcome
Rate of completion of treatment within 6 months
68.4%
35.3%
68.4 %
51.3 %
34.2 %
17.1 %
0.0 %
Immediate treatment
initiation
Standard of
care
Significant
increase ▲
NNT = 3
Significant increase in the rate of completion of treatment within 6 months (68.4% vs. 35.3%; RR 1.9, 95% CI 1.4 to 2.6).
Secondary outcomes
Significant increase in the rate of treatment initiation within 6 months (85.7% vs. 46.1%; RR 1.9, 95% CI 1.5 to 2.3).
Significant increase in treatment initiation within data lock (88.8% vs. 70.6%; RR 1.3, 95% CI 1.1 to 1.5).
No significant difference in the rate of sustained virologic response at least 4 weeks after completion of treatment (61.2% vs. 64.7%; RR 0.95, 95% CI 0.76 to 1.2).
Conclusion
In HCV RNA-positive patients admitted for inpatient care, immediate treatment initiation was superior to standard of care with respect to the rate of completion of treatment within 6 months.
Reference
Håvard Midgard, Kristian Braathen Malme, Charlotte Meinich Pihl et al. Opportunistic treatment of hepatitis C infection among hospitalized people who inject drugs (OPPORTUNI-C): A stepped wedge cluster randomized trial. Clin Infect Dis. 2024 Mar 20;78(3):582-590.
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