Efficacy And Safety Of Pegylated-Interferon Alpha Therapy In Patients With Chronic Hepatitis B In Recource-Limited Settings: A Serbian Single-Center Experience

Background/Aim. In Serbia, pegylated interferon (PEG-IFN) alpha-2a has been registered since 2013 for the treatment of patients with chronic hepatitis B (CHB). Numerous advantages, new experiences during the past five years and lack of any published data in our specific population, have initiated this study, with the aim to examine efficacy and safety of PEG-IFN in patients in a Serbian referral center. Methods. This prospective study included 36 patients with CHB who were treated in the Hepatology Department of the Clinic for Infectious and Tropical Diseases, Clinical Center of Serbia in Belgrade, during 2012-2017. Patients had a standard 48-week treatment protocol with PEG-IFN, with measurements of liver enzymes, serology and viraemia before, during, at the end of the treatment and follow-up 6 months afterwards. Treatment outcome was determined using serology (clearance of HBeAg), biochemical [normalization of alanine aminotransferase (ALT)] and virological response [hepatitis B virus (HBV) DNA < 2,000 IU/mL]. Results. Virological success in patients with HBeAg positive CHB was achieved in 50% of patients, HBeAg clearance in 62.5%, and normalization of ALT in 37.5% of patients. In patients with HBeAg negative CHB, 38% of the patients achieved virologic success, biochemical success was obtained in 47.6% of the patients and only one (4.7%) patient had HBsAg clearance. Conclusion. PEG-IFN is important for treatment of patients with CHB in well-defined situations, and in our population success rates are similar to other published studies. Although safety and tolerability are satisfactory, there is a possibility of more serious side-effects so it is necessary to monitor patients regularly during the treatment.