Abstract
Randomized controlled comparative open trials were conducted for bulevirtide, a first-in-class HBV and HDV entry inhibitor. Objective. To evaluate the efficacy and safety of bulevirtide (monotherapy and combination therapy with pegylated interferon alpha (pegIFN)) in chronic hepatitis D (CHD) patients. Trials results in 48 weeks of treatment demonstrated high rates of virologic response with monotherapy (60%, median HDV RNA decline 2.84 log10 IU/mL) and with combination therapy (100%, median HDV RNA decline 5.21 log10 IU/mL, HDV RNA negativation in 80% patients, maintained virologic response in 24 weeks after treatment completion – in 73% patients); biochemical response with monotherapy (ALT normalization in 73% patients); serological response with combination therapy (HBsAg clearance rate 47%, HBsAg negativation – 20% HBsAg-seroconversion – 13%); bulevirtide superiority over peginterferon alpha in terms of efficacy; good safety profile and tolerability of bulevirtide, lack of drug discontinuation due to adverse events (AEs), serious drug-related AEs, high adherence to treatment. Bulevirtide is recommended as a first-line treatment for CHD as a part of combination therapy with pegIFN and as monotherapy (in patients with contraindications to PegIFN or PegIFN intolerability). Key words: chronic hepatitis D, bulevirtide, combination therapy with pegylated interferon
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