ViiV Healthcare announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Tivicay (dolutegravir) 10mg and 25mg strength tablets, lowering the weight limit from ≥40kg to ≥30kg in patients aged 6–<12 years old, for the treatment of HIV-1. 

The updated labeling now reflects the use of Tivicay for two pediatric groups: those weighing ≥30kg who are treatment-naive and who are treatment experienced, as long as they have not taken an integrase inhibitor. 

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The FDA approval was based on 24-week data from a Phase 1/2 multi-center, open-label, non-comparative, P1093 IMPAACT study that evaluated dolutegravir in combination regimens in HIV-1 infected infants, children, and adolescents. The primary objectives were to select a dolutegravir dose for chronic dosing; to determine the safety and tolerability of the dose, to evaluate the steady-state pharmacokinetics (PK) of dolutegravir in combination with other antiretrovirals, and to determine the dose of dolutegravir that achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in children and adolescents.

The data showed treatment with Tivicay + optimized background regimen (OBR) was well tolerated and effective through Week 24 in HIV-1 infected patients aged 6–12 years weighing ≥30kg. The adverse event profile in this study were consistent to that for adults. No Grade 3 or 4 drug-related adverse events were reported, and none led to discontinuation. 

Tivicay is an integrase strand transfer inhibitor (INSTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV. It is now available as 10mg, 25mg, and 50mg strength tablets in 30-count bottles.

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