Experience of long-term bulevirtide monotherapy in patients with chronic hepatitis D in real-world practice

The objective is to study the efficacy and safety of long-term use of bulevirtide in monotherapy regimen of 2 mg/day in chronic hepatitis D in real practice. Patients and methods. The results of treatment for 144 weeks were studied in 41 patients, including compensated (15 patients) and decompensated (Child–Pugh class B, 6 patients) cirrhosis; 22 patients were followed up for more than 144 weeks (from 144 to 168 weeks). Results. After 144 weeks of treatment virological response was achieved in 70% of patients, aviremia – in 27%; median reduction of HDV RNA level from baseline was 3.2 log10 (from 6.4 to 3.1 log10) (p < 0.001); virological efficacy increased with increasing duration of treatment; normalization of ALT level was observed (decrease from 58.0 to 24.0 U/L, median decrease – 30 U/L (p < 0.001)), increase in the proportion of patients with normal ALT level from 29% initially to 89%, decrease in relative liver density at elastometry from 14.6 to 8.9 kPa (p = 0.02), fibrosis indices APRI (from 1.5 to 0.6) and FIB-4 (from 3.6 to 2.4) (p < 0.001). In patients treated for more than 144 weeks, the virologic response rate was 82%, the aviremia rate was 41%, and the achieved effect in terms of biochemical response and reduction in non-invasive markers of fibrosis was maintained. No serious adverse events (AEs), cases of treatment withdrawal due to AEs, deterioration of liver function were observed during treatment. All patients with Child-Pugh class B cirrhosis showed compensation within 24–48 weeks of treatment, with disappearance of hepatic encephalopathy (1 patient), ascites (6 patients). Conclusion. The analysis demonstrated the efficacy, safety and good tolerability of long-term monotherapy with bulevirtide, including in compensated and decompensated cirrhosis. Further study of the optimal duration of CHD treatment is needed to achieve its goals. Key words: bulevirtide, decompensated cirrhosis, compensated cirrhosis, monotherapy, chronic hepatitis D