Direct-acting antiviral treatment in real world patients with hepatitis C not associated with psychiatric side effects: a prospective observational study

Abstract

BackgroundTreatment 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.MethodsConsecutive 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.ResultsAt 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%.ConclusionsDespite 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.

Hepatitis C virus infection in Australian psychiatric inpatients: A multicenter study of seroprevalence, risk factors and treatment experience

“…Despite this, they appear to be underserved with reported low rates of screening, at least in part due to neuropsychiatric adverse effects of interferon. However, the lack of adverse side effects with the new directly acting antiviral HCV drugs (DAAs) must be utilised, and these patients prioritised for HCV screening and treatment . Australia is a world leader in HCV eradication with its unrestricted access to DAA therapy.…”

“…screening and treatment. 3 Australia is a world leader in HCV eradication with its unrestricted access to DAA therapy. Identification of previously neglected opportunities for treatment by screening high risk but marginalised populations such as patients with psychiatric comorbidities is a crucial step in its march towards HCV eradication.…”

Improving hepatitis C direct‐acting antiviral access and uptake: A role for patient‐reported outcomes and lived experience

“…54 Patients reported experiencing significantly fewer depressive symptoms at 12 weeks post treatment compared to baseline (as measured by the Montgomery Åsberg Depression Rating Scale). 54 Other studies have highlighted significant improvements in cirrhotic symptoms (Cirrhosis-Related Symptom Score), psychological distress (Kessler-6 Score), sleep quality (Pittsburgh Sleep Quality Index) and cognitive function post DAA treatment compared to baseline. 55,56 Recent data from placebo-controlled clinical trials underscores the association between viral clearance and improvements in patient-reported outcomes.…”

“…Despite the abundance of clinical trial data, there is minimal “real‐world” data on more specific patient‐reported outcomes and DAA treatment . A recent real‐world study focused on psychiatric specific in a sample of people living with hepatitis C with frequent substance dependence (65%) or history of psychiatric disorder (88%) . Patients reported experiencing significantly fewer depressive symptoms at 12 weeks post treatment compared to baseline (as measured by the Montgomery Åsberg Depression Rating Scale) .…”

“…A recent real‐world study focused on psychiatric specific in a sample of people living with hepatitis C with frequent substance dependence (65%) or history of psychiatric disorder (88%) . Patients reported experiencing significantly fewer depressive symptoms at 12 weeks post treatment compared to baseline (as measured by the Montgomery Åsberg Depression Rating Scale) . Other studies have highlighted significant improvements in cirrhotic symptoms (Cirrhosis‐Related Symptom Score), psychological distress (Kessler‐6 Score), sleep quality (Pittsburgh Sleep Quality Index) and cognitive function post DAA treatment compared to baseline …”