Key result
Direct-acting antivirals linked to ~22% lower depression scores in HCV patients with psychiatric morbidity.
Why the study?
Do direct-acting antivirals cause psychiatric side effects in patients with Hepatitis C virus infection?
Observational (n=17)
Open-label
No
Do direct-acting antivirals cause psychiatric side effects in patients with Hepatitis C virus infection?
Absolute Event Rate: 8.3% vs 10.7%
p-value: p=0.01
Direct-acting antivirals for HCV are well-tolerated psychiatrically, even in patients with a high burden of baseline psychiatric morbidity and substance abuse.
Associated with reduced depressive symptoms in high-morbidity HCV patients; leaves open causal confirmation and practice change pending RCTs.
BACKGROUND: Treatment of Hepatitis C virus (HCV) infection has evolved from interferon (IFN)-based treatments to direct-acting antivirals (DAAs). Patients with HCV have an elevated psychiatric morbidity (including substance abuse) and patients with such comorbidity have often been excluded from treatment with IFN. To date, little is known about psychiatric adverse effects of DAA-based regimens. We therefore aimed to study the psychiatric side effects of new IFN-free treatment for HCV (including depressive symptoms and sleep) in real world patients also including those with a history of psychiatric diagnosis, substance abuse or drug dependence. METHODS: Consecutive patients were monitored during treatment with three of the latest DAA agents (sofosbuvir, simeprevir and daclatasvir). Repeated expert psychiatric assessments from baseline to 12 weeks post-treatment were performed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) clinical version and the self-report versions of the Montgomery Åsberg Depression Rating Scale (MADRS-S) and the Pittsburgh Sleep Quality Index (PSQI). Friedman's test was performed to calculate differences in the MADRS-S and PSQI over time. In a post-hoc analysis Wilcoxon's test was used to compare baseline depressive symptoms with those at post-treatment. Spearman's rank correlation test was conducted in another post-hoc analysis to evaluate the correlation between symptoms of depression and HCV viral load at baseline. RESULTS: At baseline, 15/17 patients (88%) had a history of any psychiatric diagnosis; 11 (65%) had a history of substance abuse or dependence; and 11 (65%) had previously been treated with IFN and six of those had experienced psychiatric side effects. There was no correlation between depressive symptoms and HCV viral load at baseline. Symptoms of depression did not increase during DAA treatment and were lower 12 weeks post-treatment compared with baseline: MADRS-S 10.7 vs. 8.3 (p = 0.01). This observation held when excluding patients taking antidepressant medication. Sleep quality did not significantly change during treatment. Adherence to treatment was estimated to 95% and sustained virological response was 88%. CONCLUSIONS: Despite high psychiatric morbidity, including previous substance abuse, patients successfully completed DAA treatment without increasing depressive symptoms or sleep disturbance. Symptoms of depression were significantly reduced 12 weeks after DAA treatment.
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Sundberg et al. (2018) conducted an observational in Hepatitis C virus (HCV) infection (n=17). Direct-acting antivirals (sofosbuvir, simeprevir, daclatasvir) vs. Baseline (pre-treatment) was evaluated on Depressive symptoms (MADRS-S score) at 12 weeks post-treatment compared to baseline (p=0.01). Direct-acting antiviral treatment in patients with Hepatitis C and high psychiatric morbidity significantly reduced depressive symptoms, with MADRS-S scores decreasing from 10.7 at baseline to 8.3 at 12 weeks post-treatment.
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