Antiviral therapy experience in patients with chronic hepatitis D and decompensated cirrhosis

Abstract

Objective. To evaluate the possibility of using bulevirtide, the HBV and HDV entry inhibitor, in patients with chronic hepatitis D (CHD) at the stage of decompensated cirrhosis. Patients and methods. The results of the use of bulevirtide 2 mg in 14 patients with CHD at the stage of cirrhosis with impaired liver function – class B (13 patients) and C (1 patient) according to Child–Pugh were analyzed; 12 patients received monotherapy with bulevirtide, 2 patients received combination therapy with bulevirtide and peginterferon. Results. The use of bulevirtide for 48 weeks demonstrated a reduction in HDV RNA levels from 6.1 log10 to 3.6 log10 (p = 0.006); the achievement of a virological response in 70% of patients, a decrease in the level of alanine aminotransferase (ALT) from 52 to 29 U/L (р = 0,04), an increase in the frequency of detection of normal ALT levels compared with the baseline (from 43 to 82%), a decrease in liver stiffness from 20.8 kPa to 18.6 kPa (p = 0.016) (with a median decrease of 10.1 kPa); safety and good tolerability (no serious adverse events (AEs), severe or moderate AEs, cases of discontinuation of treatment). Positive dynamics of liver function parameters was observed: a decrease in the severity of liver disease to the level of compensated cirrhosis (decline in Child–Pugh score by 2 points), the frequency of hepatic encephalopathy (from 86 to 9%), ascites (from 64 to 18%), bilirubin levels, increased levels of albumin, prothrombin. The dynamics of the number of leukocytes and platelets during treatment did not require treatment correction. Conclusion. The analysis of the first experience in Russia of antiviral therapy for CHD and decompensated cirrhosis allows us to recommend the use of bulevirtide in this category of patients. Further studies are needed to clarify the optimal treatment regimens, the impact of treatment on clinical outcomes, the risk of hepatic complications (decompensation, HCC, death from liver failure or transplantation) and patient survival. Key words: bulevirtide, chronic hepatitis D, decompensated cirrhosis, chronic liver failure