Aa
sRNAI VIR-2218 with monoclonal antibody VIR-3434: Phase 2 MARCH trial
Please see the full report for details. Here are Summary of Results:
-The combination of VIR-2218 plus low-dose VIR-3434 was generally well tolerated; reported adverse events were generally mild with no discontinuations from treatment
-When co-administered for 5 or 12 weeks, VIR-2218 and VIR-3434 were associated with a 2.7 to 3.1 log10 IU/mL reduction in HBsAg, with 90% of participants achieving HBsAg < 10 IU/mL by end of treatment
-HBsAg rebounded after treatment but remained almost 1 log10 IU/mL below baseline at 48 weeks after the end of treatment
-Among a small subset of participants who discontinued NRTI therapy, most remain off-treatment
Key Takeaways
- Part A of the MARCH study successfully established proof-of-concept for the combination of VIR-2218 plus VIR-3434: low-dose, short-duration regiments were well tolerated and resulted in addictive antiviral activity
-These data, together with VIR-2218 plus PEG-IFNalpha data showing 31% HBsAg seroclearance at end of treatment, support the evaluation of longer durations of VIR-2218 plus VIR-3434 with and without PEG-IFNalpha in Part B of the MARCH study
-The combination of VIR-2218 plus low-dose VIR-3434 was generally well tolerated; reported adverse events were generally mild with no discontinuations from treatment
-When co-administered for 5 or 12 weeks, VIR-2218 and VIR-3434 were associated with a 2.7 to 3.1 log10 IU/mL reduction in HBsAg, with 90% of participants achieving HBsAg < 10 IU/mL by end of treatment
-HBsAg rebounded after treatment but remained almost 1 log10 IU/mL below baseline at 48 weeks after the end of treatment
-Among a small subset of participants who discontinued NRTI therapy, most remain off-treatment
Key Takeaways
- Part A of the MARCH study successfully established proof-of-concept for the combination of VIR-2218 plus VIR-3434: low-dose, short-duration regiments were well tolerated and resulted in addictive antiviral activity
-These data, together with VIR-2218 plus PEG-IFNalpha data showing 31% HBsAg seroclearance at end of treatment, support the evaluation of longer durations of VIR-2218 plus VIR-3434 with and without PEG-IFNalpha in Part B of the MARCH study
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