Safety, Tolerability and Antiviral Activity of GST-HG131 in Chronic Hepatitis B: A Randomized, Double-Blind Phase IIa Study.
Yuming Guo, Zhe Xu, Yuanyuan Li et al.
✦ AI-curated · Sources linked
In 30 seconds
This randomized, double-blind, placebo-controlled Phase IIa trial assessed oral GST-HG131 in 45 adults with chronic hepatitis B receiving nucleos(t)ide analogue monotherapy. Participants received GST-HG131 at 30 or 60 mg twice daily for 28 days, or 30 mg twice daily for 12 weeks, with placebo controls. The 12-week 30 mg group had a greater HBsAg reduction than placebo at treatment end (-0.89 log 10 IU/mL; p < 0.001). HBsAg rebounded after treatment stopped. GST-HG131 was reported as well tolerated, with no emerging safety concerns.
Key findings
- After 12 weeks of 30 mg twice-daily GST-HG131, HBsAg fell by -0.89 log 10 IU/mL versus placebo (p < 0.001).
- At Day 28, HBsAg reductions were -0.65 log 10 IU/mL with 30 mg twice daily and -0.53 log 10 IU/mL with 60 mg twice daily.
- Two-thirds of treated patients had an HBsAg reduction greater than 50%; the maximum decrease was 1.64 log 10 IU/mL.
- HBsAg rebounded after treatment discontinuation; no dose-related toxicity or emerging safety concerns were reported.
Why it matters
Reducing HBsAg is relevant to strategies seeking functional cure in chronic hepatitis B, where existing therapies often do not clear the antigen. These early trial results indicate antiviral activity when GST-HG131 is added to ongoing nucleos(t)ide analogue therapy, while also showing that the reduction was not maintained after treatment stopped. Further study is needed to establish its role in care.
What to keep in mind
This was a small Phase IIa study with short treatment periods; the abstract does not report longer-term outcomes after treatment discontinuation.