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• W4307816659 abstract "<h2>Abstract</h2><h3>Background & Aims</h3> Selgantolimod (GS-9688) is a toll-like receptor 8 (TLR8) agonist that suppresses hepatitis B virus (HBV) in vitro. In a Phase 2 study, we evaluated safety and efficacy of weekly selgantolimod treatment in virally suppressed chronic HBV patients taking oral antiviral treatment. <h3>Methods</h3> Forty-eight patients were randomized in 2 cohorts (hepatitis B e antigen [HBeAg]-positive and -negative [n=24 each]) to receive oral selgantolimod 3 mg, 1.5 mg, or placebo (2:2:1) once weekly for 24 weeks while maintaining oral antivirals. Primary efficacy endpoint was percentage of patients with ≥1 log10 IU/mL decline in hepatitis B surface antigen (HBsAg) from baseline to week 24. Post-treatment, patients continued oral antivirals for 24 weeks. <h3>Results</h3> The primary endpoint was reached by one participant, who was HBeAg-negative and received selgantolimod 1.5 mg. In contrast with placebo-treated patients (n=9), only selgantolimod-treated patients (n=39 total) had HBsAg declines greater than 0.1 log₁₀ IU/mL at weeks 24 (18%, 7/39) and 48 (26%, 10/39), HBsAg loss (5%, 2/39 through 48 weeks), or HBeAg loss (16%, 3/19 through 48 weeks). The most common adverse events in selgantolimod-treated groups were nausea (46%), upper respiratory tract infection (23%), and vomiting (23%). Gastrointestinal disorders were mostly mild and transient. Selgantolimod induced transient dose-dependent increases in serum cytokines, including IL-12p40, IFN-γ, and IL-1RA, as well as rapid redistribution of some circulating immune cell subsets. <h3>Conclusion</h3> Oral selgantolimod up to 3 mg once weekly for 24 weeks was generally safe and well tolerated and led to serologic changes associated with progression to durable cure in 2 individuals by week 48. <h3>Lay Summary</h3> Currently there are no cures for hepatitis B. The investigational drug selgantolimod is an immune stimulator that may have success with other agents to cure hepatitis B. Selgantolimod in combination with currently marketed antiviral treatment was followed by an immune response in a minority of persons with hepatitis B. <h3>ClinicalTrials.gov Identifier</h3> NCT03491553." @default.
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• W4307816659 date "2023-03-01" @default.
• W4307816659 modified "2023-10-13" @default.
• W4307816659 title "Safety and efficacy of the oral TLR8 agonist selgantolimod in individuals with chronic hepatitis B under viral suppression" @default.
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• W4307816659 doi "https://doi.org/10.1016/j.jhep.2022.09.027" @default.
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