The aim of the study was an assessment of the incidence and types of neuropsychiatric serious adverse events (NSAE) in patients with compensated chronic hepatitis C (CHC) treated with recombinant or pegylated interferon-alpha (IFN-alpha) plus ribavirin (RBV).
Method: NSAE were defined as neuropsychiatric consequences of IFN-alpha+RBV therapy that resulted in discontinuation therapy or initiation of disorders requiring hospitalization or chronic neuropsychiatric treatment. A group of 273 patients (144 males and 129 females, mean age 41) without significant past psychiatric and neurological disorders was prospectively observed. Of them 89 patients were treated with recombinant IFN-alpha+RBV. Both subgroups did not differ with regard to demographic or hepatological parameters.
Results: Overall NSAE were present in 13 patients (4.8% of the sample): psychiatric SAE emerged in 10 patients and 3 patients suffered from neurological SAE. NSAE emerged in nine patients treated with recombinant IFN-alpha and in four patients treated with pegylated IFN-alpha (p=0.03).
Conclusions: NSAE in CHC patients during IFN-alpha+RBV therapy occur rarely. However, potentially severe neuropsychiatric consequences of the treatment in some patients indicate the need for neuropsychiatric monitoring during the therapy. Treatment with pegylated IFN-alpha may be associated with less neuropsychiatric SAE than treatment with recombinant IFN-alpha in patients with compensated CHC.