Abstract

Objective. To analyze the results of antiviral therapy of patients with chronic hepatitis D (CHD) in the Republic of Sakha (Yakutia). Patients and Methods. Interim treatment outcomes over 48 weeks were studied in 36 patients receiving bulevirtide monotherapy (30 patients) and in combination with peginterferon alfa (6 patients); 11 of these patients were followed for more than 48 weeks, up to 54–118 weeks (5 and 6 patients, respectively). Results. After 48 weeks of treatment, there was a decrease in the median HDV RNA level from 7.1 log10 to 4.6 log10, with a median reduction of 2.2 log10 ( p < 0.001) (2.1 log10 with monotherapy (p < 0.001), 4.1 log10 with combination therapy), a virologic response rate of 64% (53% and 100%, respectively); and an aviremia rate of 18% (2 patients in each group). The median ALT level decreased from 63.0 to 33.0 U/L, the frequency of detection of normal ALT level increased from 24 to 67% (in the monotherapy group – from 18 to 69%). When treatment was continued for more than 48 weeks (up to 54–118 weeks), maintenance and/or improvement of virologic and biochemical response was observed in the majority of patients. The treatment was characterized by good tolerability, absence of serious adverse events, cases of treatment withdrawal, worsening of liver function indices in cirrhosis. Conclusion. Analysis of interim results of bulevirtide application in real practice demonstrated efficacy, safety and good tolerability of treatment, both in combination therapy and monotherapy, including in compensated liver cirrhosis. Further accumulation of treatment experience is necessary in order to develop an optimal treatment algorithm. Key words: bulevirtide, chronic hepatitis D, combined therapy, cirrhosis, monotherapy

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