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New research · Infectious Disease
Hepatology communications · 23h
StudyHepatology communications · 2026

Safety and efficacy of libevitug in patients with chronic hepatitis B and D virus coinfection: A single-center, open-label, phase IIa trial in China.

Xinrui Wang, Xiumei Chi, Yingyu Zhang … Junqi Niu
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Infectious DiseaseStudy

Libevitug achieved virological response in most patients with hepatitis D.

Safety and efficacy of libevitug in patients with chronic hepatitis B and D virus coinfection: A single-center, open-label, phase IIa trial in China.

Xinrui Wang et al. · Hepatology communications · 2026
Background

Chronic HBV and HDV coinfection represents the most severe form of viral hepatitis.

Purpose

This study aimed to assess the safety and efficacy of libevitug (HH-003), a novel human monoclonal antibody targeting the PreS1 domain of the HBV large envelope protein, in patients with chronic HBV and HDV coinfection.

Methods

This single-center, open-label, proof-of-concept phase IIa clinical trial enrolled 9 participants who received i.v. infusion of 20 mg/kg libevitug every 2 weeks for 24 weeks, followed by a 24-week follow-up period.

n = 9 participants
77.8%
Results
77.8% of patients achieved a strong reduction in hepatitis D virus RNA.
n = 9 participants
More results

At week 24, 8 participants (88.9%) exhibited a reduction in HDV RNA ≥1 log10 from baseline, with 4 (44.4%) achieving undetectable levels.

Among the 5 participants with elevated baseline ALT, 3 (60.0%) achieved a combined virological and biochemical response (ALT normalization).

More results

At week 48, 6 participants (66.7%) maintained the virological response achieved at the end of treatment (week 24), with 3 (33.3%) maintaining undetectable HDV RNA levels.

Among the 7 participants with quantifiable HBV DNA at baseline, 2 (28.6%) achieved undetectable HBV DNA or ≥1 log10 reduction at week 24.

“
Conclusion

Libevitug demonstrated promising antiviral activity, achieving substantial HDV RNA reduction, a high rate of ALT normalization, and favorable safety and tolerability in participants with chronic HBV and HDV coinfection.

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