Background The new treatment regimens for hepatitis C virus infection have radically changed the care of patients. Recently introduced commercial products are subjected to intensive monitoring by the AIFA with the aim of evaluating both the effectiveness and safety in clinical practice. The purpose of this retrospective observational study was analysis of the incidence and severity of adverse reactions (ADRs) reported in the region of Calabria with regimens containing direct antiviral agents (DAAs), as well as evaluation of their effectiveness.
Material and Methods All ADR reporting forms for the new DAAs present in the Pharmacovigilance National Network of the Calabria region were extracted and analysed from March 2015 to May 2016. From the AIFA monitoring register data were extrapolated on treatment started and the sociodemographic characteristics of the patients. For polypharmacy patients, we analysed possible interactions.
Results 1457 new DAA regimens were started in Calabria. Patients were mostly men (52%). The most represented age group was 70–79 years (34%). 59.2% of the analysed treatments were successfully completed second therapeutic programme. In 1.1% of treatments ADRs were recorded and the report forms forwarded. Analysis of the forms showed: mean age 64.86 years (range 35–77), 60% men, associated with RBV treatment regimen (50%). Sovaldi + Olysio, Harvoni, Daklinza, Sovaldi and Viekirax regimens were associated with ADRs in 37.5%, 31.2%, 12.5%, 6.5% and 6.25% of cases. Comparing ADRs with the respective treatments started showed that they had an equally important place in treatments with Sovaldi + Olysio (1.46%) and Harvoni (0.90%). 12.5% of reported ADRs against Harvoni were considered serious for the occurrence of urosepsis and pneumonia. 87.5% were considered not serious. In other regimens ADRs reported were: fatigue, insomnia, hives, cough and dermatitis. Anaemia was the ADR reported more for therapeutic regimens associated with the use of RBV (58%). 25% of ADR cases occurred in patients who were administered polypharmacy; the analysis did not detect any possible interaction to account for the ADR.
Conclusions Our data provide an overview of the safety of new DAAs. The presence of ADRs in the elderly and those receiving polypharmacy requires activation of careful monitoring of the appropriateness of the prescriptions and interactions of therapies. This can only be implemented by management by a multidisciplinary team.
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