Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection

Nucleos(t)ide reverse transcriptase inhibitors do not completely suppress HBV DNA in chronic HBV infection (cHBV). Vebicorvir (VBR) is an investigational core inhibitor that interferes with multiple aspects of HBV replication. This phase II trial evaluated the safety and efficacy of VBR in combinati...

Full description

Saved in:
Bibliographic Details
Published in:Journal of hepatology 2022-11, Vol.77 (5), p.1265-1275
Main Authors: Sulkowski, Mark S., Agarwal, Kosh, Ma, Xiaoli, Nguyen, Tuan T., Schiff, Eugene R., Hann, Hie-Won L., Dieterich, Douglas T., Nahass, Ronald G., Park, James S., Chan, Sing, Han, Steven-Huy B., Gane, Edward J., Bennett, Michael, Alves, Katia, Evanchik, Marc, Yan, Ran, Huang, Qi, Lopatin, Uri, Colonno, Richard, Ma, Julie, Knox, Steven J., Stamm, Luisa M., Bonacini, Maurizio, Jacobson, Ira M., Ayoub, Walid S., Weilert, Frank, Ravendhran, Natarajan, Ramji, Alnoor, Kwo, Paul Yien, Elkhashab, Magdy, Hassanein, Tarek, Bae, Ho S., Lalezari, Jacob P., Fung, Scott K., Yuen, Man-Fung
Format: Article
Language:English
Subjects:
ABI-H0731
chronic hepatitis B virus
core inhibitor
entecavir
nucleos(t)ide reverse transcriptase inhibitor
phase 2
treatment-naïve
Vebicorvir
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Nucleos(t)ide reverse transcriptase inhibitors do not completely suppress HBV DNA in chronic HBV infection (cHBV). Vebicorvir (VBR) is an investigational core inhibitor that interferes with multiple aspects of HBV replication. This phase II trial evaluated the safety and efficacy of VBR in combination with entecavir (ETV) in treatment-naïve patients with cHBV. HBeAg-positive, treatment-naïve patients without cirrhosis were randomised 1:1 in a double-blind manner to once-daily VBR 300 mg+ETV 0.5 mg or placebo (PBO)+ETV 0.5 mg for 24 weeks. The primary endpoint was change in mean log10 HBV DNA from Baseline to Week 12 and 24. All patients in both treatment groups (PBO+ETV: 12/12; VBR+ETV: 13/13) completed the study. At Week 12, VBR+ETV led to a greater mean (SD) reduction from Baseline in log10 IU/ml HBV DNA (–4.45 [1.03]) vs. PBO+ETV (–3.30 [1.18]; p = 0.0077). At Week 24, VBR+ETV led to a greater reduction from Baseline in log10 IU/ml HBV DNA (–5.33 [1.59]) vs. PBO+ETV (–4.20 [0.98]; p = 0.0084). Greater mean reductions in pregenomic RNA were observed at Week 12 and 24 in patients receiving VBR+ETV vs. PBO+ETV (p
ISSN:0168-8278
1600-0641
DOI:10.1016/j.jhep.2022.05.027