May direct-acting antiviral regimens for chronic hepatitis C virus infections have neuropsychiatric adverse drug reactions? A pilot study conducted in patients receiving sofosbuvir-based regimens in the real-life setting

Abstract

Until 2011, the standard-of-care therapy for chronic hepatitis C virus (HCV) infections relied on pegylated interferon, whose psychiatric adverse drug reactions are well known to treating physicians. From 2014, direct-acting antivirals (DAAs) with fewer adverse drug reactions and not contraindicated in patients affected by psychiatric disorders have been used. The aim of the present study is to assess the development of psychiatric effects related to DAA regimens based on sofosbuvir in the real-life setting. A pilot retrospective study in the real-life setting, based on administration of a battery of anonymous assessment scales, including the Specific Level Of Functioning assessment and health physical inventory (SLOF) and the Structured Clinical Interview for DSM-IV Axis II disorders (SCID II), was conducted in a sample of 27 adult patients (13 males and 14 females) with chronic HCV infection and F3/F4 fibrosis who had completed a 3- or 6-month sofosbuvir-based DAA regimen. This schedule ended on January 1, 2016. Statistical analysis was performed using SPSS PASW-statistic 18.0. At the end of our study, 13 of the 27 enrolled patients (48.14%) reported having psychiatric symptoms during and/or after therapy, while the remaining 14 patients denied experiencing any symptoms. The most common symptoms were anxiety (40.7 and 29.6% psychic and somatic type, respectively), stress (46.2%), depressed mood (18.5%), hypochondria (18.5%), initial, middle and delayed insomnia (14.8% for each type), fear (14.8%), modification of the intellectual sphere (14.8%), and irritability (14.8%); no suicide attempt or depersonalization/de-realization disorder were reported. No patients withdrew from therapy due to psychiatric adverse drug reactions. This pilot study seems to indicate that the occurrence of the psychiatric effects seems to be more frequent than previously reported in the registration trials or the summary of product characteristics, which is likely due to different characteristics between the patients enrolled in the registration trials and the patients in daily clinical practice. Since the therapy can currently be offered to many patients with chronic HCV infection who in the past were excluded from treatment because of psychiatric or mental disorders, only a prospective trial in the real-life setting may assess the real impact of therapy with DAAs on the patients’ psychiatric sphere.