Poster Presentations

Session Title: Category 5g. VIRAL HEPATITIS: g. HEPATITIS C - CLINICAL (THERAPY)
Presentation Date: Apr 15, 2010

ASSESSMENT OF PAROXETINE IN THE PREVENTION OF DEPRESSION IN PATIENTS WITH CHRONIC HEPATITIS C TREATED BY PEG-INTERFERON-RIBAVIRIN.: A DOUBLE-BLINDED, RANDOMIZED STUDY. ANRS HC18 PAROPEG

J.-P. Bronowicki¹*, V. Canva², A. Tran³, M.-N. Hilleret⁴, S. Pol⁵, M. Mainard⁶, M. Bourlière⁷, V. de Ledinghen⁸, A. Abergel⁹, K. Barange¹⁰, N. Ganne¹¹, P. Cales¹², V. Di Martino¹³, O. Goria¹⁴, J.-M. Molina¹⁵, L. Alric¹⁰, J.-J. Raabe^16
1CHU de Nancy, Vandoeuvre-lès-Nancy, ²CHU de Lille, Lille, ³CHU de Nice, Nice, ⁴CHU de Grenoble, Grenoble, ⁵Hopital Cochin, Paris, ⁶CHU de Lyon, Lyon, ⁷Hopital Saint Joseph, Marseille, ⁸CHU de Bordeaux - Hopital Pellegrin, Bordeaux, ⁹CHU de Clermont Ferrand, Clermont Ferrand, ¹⁰CHU de Toulouse, Toulouse, ¹¹Hopital Jean Verdier, Bondy, ¹²CHU Angers, Angers, ¹³CHU de Besançon, Besançon, ¹⁴CHU de Rouen, Rouen, ¹⁵Hopital Saint-Louis, Paris, ¹⁶CHR Metz, Metz, France. *jp.bronowicki@chu-nancy.fr

Background/aim: Treatment with PEG-interferon (PEG-IFN) for chronic hepatitis C (CHC) is associated with depression. The aim of the study was to determine the efficacy of paroxetine for preventing depression induced by PEG-IFN in CHC patients.
Methods: We designed a prospective, multicenter, double-blind, placebo-controlled trial of the antidepressant paroxetine in CHC adult patients who were eligible for therapy with PEG-IFN-alpha 2a or 2b and ribavirin [NCT00196664]. Patients with symptomatic mental disorders at baseline were excluded, as well as those with HBV or HIV coinfection. The study was conducted in 17 French hospitals. Patients were randomly assigned to receive paroxetine (20 mg/day, n= 73) or placebo (n=76). Stratification was done on: PEG-IFN (2a vs 2b), history of previous antiviral treatment (no vs yes), HCV genotype (1/4/5 vs 2/3). Treatment was begun 2 weeks before PEG-IFN and continued until 2 weeks after the end of the antiviral therapy. Patients were evaluated every month until the end of PEG-IFN. Main variables were the presence of a major depression evaluated by the Mini International Neuropsychiatric Interview (MINI) and a Montgomery-Asberg Depression Rating Scale (MADRS)> 15. We hypothesized a 20 % decrease of depression incidence with paroxetine. Chi-square test and Student's T test were used for categorical and continuous variables respectively.
Results: The characteristics of the 159 included patients were as follow: male: 58 %, age: 50 years, history of psychiatric disorders: 30 %, history of drug use: 32 %, METAVIR F3-F4: 48 %, genotype 1/4/5: 58 %. 64 % patients were naïve of treatment and 52 % received PEG-IFN 2a. The 2 arms were well matched. The incidence of depression was not statistically different between the 2 arms according to the MINI (paroxetine: 4 % vs 11 %) and the MADRS (paroxetine: 18 vs 28 %). There was no difference in terms of antiviral dose reduction (34% vs 36 %) and serious adverse events (22% vs 14%). The SVR rates were also comparable (46 vs 54 %).
Conclusion: Our results do not support the systematic use of paroxetine in the prevention of the depression induced by PEG-IFN in the treatment of CHC.