The Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir; Viiv Healthcare) tablets for oral suspension, for the treatment of HIV-1 infection in treatment-naïve or -experienced but integrase inhibitor-naïve pediatric patients aged ≥4 weeks and weighing at least 3kg, in combination with other antiretroviral agents. 

The approval also expanded the use of the already approved Tivicay film-coated tablets for children weighing ≥14kg. The 50mg tablet is limited to children weighing ≥20mg. 

The FDA approval was based on data from 2 ongoing studies in children aged 4 weeks to 18 years; IMPAACT P1093 (NCT03016533), a multicenter safety, tolerability and dose-finding trial, and ODYSSEY [PENTA20] (NCT02259127), a randomized, multicenter, control efficacy trial in first- and second-line treatment. 

The IMPAACT P1093 study included 75 infants, children, and adolescents aged at least 4 weeks to 18 years (median age: 27 months) with HIV-1. Patients received the recommended dose of Tivicay or Tivicay PD as determined by weight and age. Results showed that at week 24, 62% of patients achieved HIV-1 RNA <50 copies/mL and 86% achieved HIV-1 RNA <400 copies/mL. At week 48, 69% of patients achieved HIV-1 RNA <50 copies/mL and 79% achieved HIV-1 RNA <400 copies/mL. The median CD4+ cell count increase from baseline to week 24 and 48 was 105 cells/mm3 and 141 cells/mm3, respectively.  

Tivicay PD is the first integrase inhibitor formulated as a dispersible tablet for oral suspension. Tivicay is also available in 10mg, 25mg, and 50mg tablets. The film-coated tablets and dispersible tablets for oral suspension are not interchangeable on a milligram per milligram basis due to differing pharmacokinetic profiles. 

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Tivicay PD will be supplied as a 5mg dispersible tablet in a strawberry cream flavor. Each bottle of Tivicay PD contains 60 tablets and is packaged with a 30mL dosing cup and a 10mL oral dosing syringe. The tablets should be dispersed in the supplied cup and should be administered within 30 minutes of mixing.

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