Follow-Up of Adverse Drug Reactions from Peginterferon Alfa-2b—Ribavirin Therapy

In a prospective, observational pharmacovigilance study conducted at a French university hospital's gastroenterology department, 87 patients infected with the hepatitis C virus (HCV) were treated with peginterferon alfa-2b plus ribavirin. Of these, 51 patients started therapy, with one lost to follow-up. Serious adverse drug reactions (ADRs) occurred in 10 patients (20%), including one suicide, three hospitalizations, and six definitive discontinuations of the therapy. ADRs were the main or contributing factor for drug withdrawal in 8 patients (16%). Dosage reductions were necessary in 10 patients (20%), which was less frequent than in clinical trials. The study found a similar frequency of hair loss, a higher frequency of injection-site reactions, a lower frequency of depression or insomnia, and a higher frequency of endocrine ADRs or blurred vision compared to clinical trials. The study concluded that there are some differences in the frequencies of ADRs compared to clinical trial data and that longer monitoring and a medical staff member trained in pharmacovigilance are important for better understanding the ADRs of pegylated interferon.