The evaluation of the effects of pegilated interferon /lamivudin treatment on auditory functions and other side effects in patients with chronic Hepatitis B

This study was conducted to evaluate the effects of use of pegileinterferon monotherapy and combined pegilated interferon+lamivudin treatment on hearing functions in patients with chronic hepatitis B (CHB) and determine the side effects that occurred during the treatment period.A total of 54 patients diagnosed with CHB infection was divided into 4 treatment groups: Pegilated interferon-alfa 2a was administered to patients in group 1, pegilated interferon-alfa 2a+lamivudin was given to group 2, group 3 patients received pegilated interferon-alfa 2b and group 4 had pegilated interferon-alfa 2b+lamivudin treatment. Patients were evaluated immediately before the start of the study and at 12th, 24th and 48th months after treatment for determining systemic side effects ( fever, flu-like syndrome, myalgia, fatigue, arthralgia, headache, anorexia, nausea, diarrhea, cough, concentration disorder, excessive sleep or insomnia, weight loss, loss of libido, hair loss, anxiety, delirium, suicidal ideation, epilepsy), hematological, biochemical and auditory side effects (otalgia, tinnitus, vertigo and dizziness).The most common systemic side effects found in all treated patients were flu-like syndrome, myalgia, fatigue, concentration disorder, weight loss, and hair loss. There was no significant difference between the groups in respect to the occurrence of individual side effects during the treatment period, however examining the groups independent of the total treatment time at 12th, 24th and 48th revealed no significantly increased detection of side effects except fever, anorexia, excessive sleep (p<0.05). The incidence of side effects had a tendency to decrease at 48th month when compared to 12th month follow up. There was no statistically significant difference between groups in respect to treatment responses evaluated by appropriate criteria. An average of 1-10 dB hearing threshold increase was determined at 12th, 24th and 48th months in all treatment groups when compared to levels measured at the begining of treatment. However, this rise for each group at the follow up was statistically not significant when compared to the hearing threshold measured at the begining. The maximum increases at hearing thresholds were found to be in the high frequencies ( 10000, 12000 and 16000 Hz). The most frequently encountered side effects due to treatment were tinnitus, vertigo and balance disorder, respectively.In conclusion, we did not find any superiority of pegileforms to each other and similarly, we found no advantage of combined treatment over monotherapy in respect to systemic and hematological side effects as well as treatment outcomes. Although there was no statistically significant difference, hematological side effects were slighlty more common in combined treatment group compared to monotherapy arm. We suggest that in all treatment groups slight increases in hearing threshold, (despite not statistically significant) implicated usefulness to monitor the auditory functions in patients using PEG-IFN.Key words: Chronic hepatitis B, Pegylated interferon, Hearing loss, Side effects.