In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children and adolescents ≥20kg utilized a population pharmacokinetic (POP PK) model-based approach to achieve similar adult TMR exposures following FTR 600mg BID administration with combination therapy that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.
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Occurrence of the following events through Week 24
Timeframe: 24 weeks
AUC(0-tau)
Timeframe: at week 1, 4, 12, 24, 48
Cmax
Timeframe: at week 1, 4, 12, 24, 48
Ctau of temsavir across weight bands
Timeframe: at week 1, 4, 12, 24, 48