Open AccessEfficacy and safety of bulevirtide in patients with chronic hepatitis D and compensated cirrhosis
Author(s) -
Pavel Bogomolov,
Ivashkin Vt,
А. О. Буеверов,
И. В. Маев,
Olga Sagalova,
S.S. Sleptsovа,
N.D. Yushchuk,
Д. А. Гусев,
К. В. Жданов,
Vladimir Chulanov
Publication year - 2021
Publication title -
terapevtičeskij arhiv
Language(s) - English
Resource type - Journals
eISSN - 2309-5342
pISSN - 0040-3660
DOI - 10.26442/00403660.2021.11.201163
Subject(s) - medicine , cirrhosis , gastroenterology , tolerability , pegylated interferon , adverse effect , combination therapy , chronic hepatitis , ribavirin , immunology , virus
Aim. To study the efficacy and safety of bulevirtide, the HBV and HDV entry inhibitor.
Materials and methods. Analysis of the results of using bulevirtide in randomized controlled open-label comparative studies MYR202 and MYR203 in 56 patients with chronic hepatitis D and compensated cirrhosis, in monotherapy and combination with pegylated interferon alpha-2a (PEG-IFN).
Results. Monotherapy with bulevirtide for 24 weeks in the MYR202 study in 46 patients with compensated liver cirrhosis demonstrated: 1) a high rate of virological (100%) and biochemical response (alanine aminotransferase normalization rate 45.7%), 2) superiority of bulevirtide in efficacy over the control group (tenofovir), 3) comparability of treatment efficacy in patients with and without cirrhosis, 4) no progression of liver fibrosis with elastometry in most patients.
Treatment with bulevirtide in monotherapy and combination with PEG-IFN for 48 weeks in 10 patients with compensated liver cirrhosis in the MYR203 study was accompanied by a high rate of virological response (80%) and normalization of alanine aminotransferase (70%).
Bulevirtide was well tolerated, there was no deterioration in tolerability compared with patients without cirrhosis, there were no serious adverse events and cases of treatment cancellation due to adverse events.
Conclusion. Bulevirtide is recommended as the first line of treatment for chronic hepatitis D in patients with compensated cirrhosis in monotherapy and combination with PEG-IFN.