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Semi-mechanistic PK/PD modeling and simulation of sequential siRNA and bepirovirsen treatment predicts added benefit in HBsAg response in support of Phase 2b dose selection
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AASLD 2024 | November 15-19, 2024 | San Diego, CA, US
Nadia Noormohamed1, Mohamed Ismail2, Mindy Magee1, Susan Dixon3, Maximilian Lee4, Melanie Paff4, Ahmed Nader1
1Clinical Pharmacology Modeling and Simulation, GSK, Collegeville, PA, USA; 2Enhanced Pharmacodynamics LLC, Buffalo, NY, USA; 3Development Clinical Sciences Hepatology/GI, GSK, Stevenage, Hertfordshire, UK; 4Development, GSK, Collegeville, PA, USA
GSK receives US FDA Fast Track designation
for bepirovirsen in chronic hepatitis B......https://www.natap.org/2024/HBV/081224_01.htm
Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection....https://www.natap.org/2022/HIV/111022_01.htm
Short-term treatment with RNA interference therapy, JNJ-3989, results in sustained hepatitis B surface antigen
suppression in patients with chronic hepatitis B receiving nucleos(t)ide analogue treatment .....https://www.natap.org/2020/EASL/EASL_28.htm
Efficacy and Safety of Finite 48-week Treatment With the siRNA JNJ-3989 and the Capsid
Assembly Modulator JNJ-6379
in HBeAg Negative Virologically Suppressed Chronic Hepatitis
B Patients: Results from the REEF-2 Study....https://www.natap.org/2022/EASL/EASL_35.htm
Efficacy, safety, tolerability, and immunogenicity of JNJ-0535 following a reduction of viral antigen levels through administration of siRNA JNJ-3989 in patients with chronic HBeAg negative hepatitis B - interim data of the OSPREY study....https://natap.org/2024/EASL/EASL_102.htm
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