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Patients in the integrated and standard care treatment arms reported similar SCL-10 scores indicative of psychological stress and symptom burden, both at baseline and after the completion of DAA treatment.
Integrated hepatitis C virus (HCV) treatment is unlikely to have substantial co-benefits related to psychological distress compared to standard treatment approaches for patients with substance use disorders, according to findings from a secondary outcome analysis of the INTRO-HCV trial.
Psychological distress remained predominantly unchanged during treatment and symptom burden was substantial both at baseline and 12 weeks after direct-acting antiviral (DAA) treatment, with no significant differences observed between the integrated and standard treatment arms.1
“It is important to explore this intricate interplay between HCV, substance use, and mental health symptoms in high-quality intervention studies. Possibly, ameliorating the burden of serious somatic conditions such as HCV infection might have an added positive effect on mental health,” wrote Lars Fadnes, MD, professor in the department of global public health and primary care at the University of Bergen in Norway, and colleagues.1
The World Health Organization estimates 23% to 39% of new HCV infections occur among people who inject drugs and globally, 1 in 3 HCV deaths are attributable to injectable drug use. People who inject drugs often fail to access harm reduction and other health services necessary for treating or preventing HCV, underscoring the need for a better disease management model in this patient population.2
A multicenter, randomized controlled clinical trial, INTRO-HCV recruited patients with substance use disorder and chronic HCV infection from opioid agonist therapy and community care clinics in Norway from 2017-2019 and randomly assigned them to a pair of treatment arms in a 1:1 ratio. Integrated treatment was delivered by multidisciplinary teams at opioid agonist treatment clinics or community care centers for people with substance use disorders and included on-site HCV testing, liver fibrosis assessment, counseling, treatment, and posttreatment follow-up. The second arm, standard treatment, was delivered in hospital outpatient clinics.3
Investigators described the primary differences between the treatment arms, noting that although oral DAA medications were administered in both groups, patients in the integrated care arm did not need to go to the hospital for appointments or travel for treatment, required less blood sampling, and connected patients with familiar clinicians rather than hospital physicians.1
A total of 298 participants were randomized to either receive integrated HCV treatment (n = 148) or standard HCV treatment (n = 150). Due to 4 deaths and 5 patients not having a baseline assessment of psychological distress, 145 participants in the integrated arm and 144 participants in the standard arm were included in the analyses. Investigators noted baseline sociodemographic characteristics were similar between both groups (all P >.05).1
A previously published report of the study’s primary outcomes, time to treatment initiation and sustained virologic response (SVR), detailed the superiority of integrated HCV treatment across both measures. A greater proportion of patients in the integrated treatment group initiated treatment within 1 year of referral (95%) compared to those in the standard treatment group (72%), although rates of SVR were comparable among the groups (85% in integrated vs 83% in standard).3
The additional analysis of INTO-HCV examined psychological distress as a secondary outcome of integrated HCV treatment, measured by Hopkins-symptom-checklist-10 (SCL-10) prior to the initiation of treatment and 12 weeks after completion. Designed to measure symptoms of mental health disorders and psychological distress, each SCL-10 item is scored on 4 dimensions from “not bothered at all” (item score = 1) to “extremely bothered” (item score = 4).1
Participants in the integrated treatment arm had a sustained virologic response of 93% compared to 73% for those in the standard treatment arm. Upon analysis, achieving SVR did not significantly reduce patients’ SCL-10 score 12 weeks after DAA treatment compared to those not achieving SVR.1
The mean SCL-10 score prior to HCV treatment was 2.2 (standard deviation [SD], 0.7) for patients receiving integrated HCV treatment and 2.2 (SD, 0.8) for those receiving standard HCV treatment, indicating substantial symptom burden across both groups. Of note, integrated HCV treatment did not significantly reduce the mean SCL-10 score from baseline to the end of 12 weeks of treatment compared with standard HCV treatment (ΔSCL-10 mean score, -0.1; 95% confidence interval [CI], -0.3 to 0.0; P = .091). Thus, psychological distress did not substantially change during the treatment period and was not significantly different between the treatment arms.1
“This randomized controlled trial showed that integrated HCV treatment is unlikely to have substantial co-benefits related to psychological distress within a 12-week timeframe of the study,” investigators concluded, noting certain subgroups may still benefit from an integrated care approach and emphasizing the importance of integrated treatment approaches in people with substance use disorders.1