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Current treatment modalities cannot cure hepatitis B virus (HBV) infection. There has been some hope that adding adjunctive therapies to available direct-acting antiviral agents could stimulate HBV-specific T-cell responses that could ultimately lead to cure.
In an industry-funded, phase II, open-label study, researchers evaluated the safety and efficacy of adding GS-4774, a yeast-based therapeutic vaccine that expresses HBV antigens, to tenofovir disoproxil fumarate (TDF) in treatment-naive HBV-infected patients. Patients with HBV DNA ≥2000 IU/mL were randomized in a 1:2:2:2 fashion to receive daily TDF 300 mg alone (n=27) or in combination with 2, 10, or 40 GS-4774 yeast units, given subcutaneously every 4 weeks until week 20 (n=168).
The p…