Efficacy and safety of bulevirtide in patients with chronic hepatitis D and compensated cirrhosis

Abstract

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.

HBV and HCV Infection Prophylaxis in Liver Transplant Recipients

“…Pegylated Interferon Alpha (PEG-IFN-alpha) has been used for decades to treat HDV infections and has shown a virologic response rate of up to 30%, with use limited by severe adverse effects that have compromised therapy and its use among patients with decompensated liver disease or in the post-transplant setting [51]. Recently, Bulevirtide, a lipopeptide that blocks the binding of HBsAgcoated particles to the sodium taurocholate cotransporter polypeptide (NTCP), which is the cellular entry receptor for both HBV and HDV, was approved by the EMA at a dose of 2 mg/day, subcutaneous injection, in patients with HDV coinfection [52]. Clinical studies have confirmed the efficacy and safety of Bulevirtide, even in patients with advanced-stage compensated cirrhosis [51].…”

“…More studies are needed to understand the mechanisms of virologic response, build models to predict therapeutic response, determine discontinuation criteria, and test drug efficacy and safety in special populations such as transplant patients [41]. Two investigational drugs, PEG-IFN and Lonafarnib, are currently in phase III, but these drugs, as well as Bulevirtide, are not been tested in transplant patients; specific prophylaxis for transplant patients for HBV/HDV co-infection is not yet available, but because HBV needs HBV to infect hepatocytes and replicate, the primary goal of post-transplant prophylaxis in patients with HDV co-infection is to prevent HBV relapse [52].…”