Advances in Pharmacoepidemiology and Drug Safety

Abstract

Development of Psychiatric Symptoms during Antiviral Therapy for Chronic Hepatitis C

Vitale G, Simonetti G, Conti F, Taruschio G, Cursaro C, Scuteri A, Brodosi L, Vukotic R, Loggi E, Gamal N, Pirillo L, Cicero AF, Boncompagni G and Andreone P

Pegylated-interferon-α (Peg-IFN) are part of chronic hepatitis C (CHC) treatment. Among several side effects, it can induce psychiatric symptoms (PS) which could require discontinuation. The aim of this study was to evaluate the incidence, onset and risk factors of PS and antiviral treatment adherence in CHC patients treated with Peg-IFN plus ribavirin (RBV). All consecutive patients who received antiviral therapy between 2005 and 2011 were subjected to a psychiatric assessment before and during treatment. Of them, 49.2% reported PS especially during the first 4 weeks. Irritability was the predominant symptom recorded. The baseline factors associated with a higher risk of developing PS were: age ≤ 50 years (OR=1.67, 95% CI=1.15-2.43), living in Northern Italy (OR=1.88, 95% CI=1.31-2.70), genotype 1 (OR=1.82, 95% CI=1.28-2.60), previous antiviral treatment (OR=1.53, 95% CI=1.07-2.19) and history of mental disorders (MD) (OR=2.32, 95%CI=1.50-3.58). There was no difference in terms of sustained virologic response (SVR) between patients with and those without a history of MD (p=0.129). On the contrary, SVR was lower in patients who developed PS compared to other ones (p<0.001) due to the higher prevalence of difficult-to-treat patients. Only 1.7% of patients dropped-out for PS. In conclusion, most of patients receiving Peg-IFN develop PS, in particular irritability, especially during the first 4 weeks. Age ≤ 50, living in Northern Italy, genotype 1 infection, previous antiviral treatment and history of MD are associated with a higher chance of developing PS.