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PREZISTA(R)(darunavir) Oral Suspension Receives European Commission Approval For Young Children With HIV-1 Infection

Darunavir oral bioavailability

The EC approval for the oral suspension was also based on TMC114-C169: a Phase I open label randomized crossover trial in healthy subjects to compare the oral bioavailability, to that of the 300mg tablet formulation in presence of low dose ritonavir under fasted and fed conditions.

About PREZISTA® (darunavir)

Darunavir is currently indicated for use in HIV-1 infected treatment-experienced children aged 6 to 18 years old and at least 20kg in body weight in combination with ritonavir and other ARTs. The licensed dosing is dependent on body weight and should not exceed 600 mg twice daily.

Since its initial approval in 2007, darunavir has also been indicated for use in HIV-1 infected treatment-naïve and treatment-experienced adult patients, including those who have been highly pre-treated, in combination with ritonavir and other ARTs. For treatment-experienced adult patients, the licensed dosing for darunavir (DVR) is 600 mg taken with 100 mg ritonavir twice daily with food or 800 mg taken with 100 mg ritonavir once daily with food for patients with no DRV Resistance Associated Mutations (RAMs) [i] and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10 6/L. For treatment-naive adult patients, the licensed dosing for darunavir is 800 mg taken with 100 mg ritonavir once daily with food.

-------------------------------------------------- i. V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V

 

Important Safety Information

In the registrational studies, darunavir was generally well tolerated. The majority of the adverse reactions reported in patients who initiated therapy with darunavir co-administered with 100 mg ritonavir were mild to moderate in severity. The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, immune reconstitution syndrome, nausea, pyrexia and rash. The most frequent serious reactions are diarrhoea, hepatitis, immune reconstitution syndrome, pyrexia and rash. Please see the Summary of Product Characteristics for a complete list of all possible side effects.

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