Brelovitug for Chronic Hepatitis D: Phase 3 AZURE-1 Results

Brelovitug, an investigational monoclonal antibody targeting hepatitis B surface antigen (HBsAg), met the primary end point in adults with chronic hepatitis D, according to late-breaking phase 3 AZURE-1 data presented by Tatyana Kushner, MD, MSCE, at The Liver Meeting 2026 in Denver, Colorado.

“It was actually quite safe and very well tolerated,” Kushner, associate professor of medicine in the Department of Gastroenterology at Weill Cornell Medicine in New York, New York, told HCPLive.

Hepatitis delta virus (HDV) relies on HBsAg to infect liver cells and causes the most aggressive form of viral hepatitis.1 Bulevirtide (Hepcludex) received FDA accelerated approval in May 2026 as the first US treatment, ending reliance on off-label pegylated interferon.2

What Did AZURE-1 Show?

AZURE-1 randomized 153 participants to brelovitug 300 mg weekly self-administered at home, 900 mg every 4 weeks in clinic, or delayed treatment. At week 24, the combined virologic and ALT response end point was achieved by 56% of participants in the weekly group and 45% in the monthly group, compared with 0% with delayed treatment (both P < .0001). HDV RNA fell by a mean 3.4 log10 IU/mL in both active arms.1

There were no treatment-related serious adverse events, grade 3 or higher adverse events, or discontinuations due to adverse events. Injection site reactions and flu-like illness were the most common events.1

Who Could Benefit?

Notably, 41% of participants had cirrhosis, 20% had at least probable clinically significant portal hypertension, and HIV coinfection was permitted.1 “Having this type of patient population really helps us have comfort in being able to prescribe this regimen to a patient population that we see in our practice,” Kushner said.

Watch the full interview to hear Kushner discuss how weekly vs monthly dosing may fit patient preferences, what week 96 follow-up must answer, and the outcomes that matter most beyond viral load.

References

1. Kushner T, Yardeni D, Dobryanska M, et al. Efficacy and safety of brelovitug monotherapy for chronic hepatitis D: primary 24-week results from the phase 3 AZURE-1 study. Late-breaking abstract presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO.
2. Campbell P. Bulevirtide receives historic first FDA approval for chronic hepatitis delta. HCPLive. May 22, 2026. Accessed November 11, 2026. https://www.hcplive.com/view/bulevirtide-historic-first-fda-approval-chronic-hepatitis-delta