PREZISTA

The Actual Benefit is substantial in the Marketing Authorisation indications.

PREZISTA 100 mg/ml, oral suspension
In view of the small number of alternative treatments, the Committee considers
that the proprietary medicinal product PREZISTA oral solution, co-administered
with a low dose of ritonavir and other antiretroviral preparations, constitutes an improvement in actual benefit (IAB III) in the treatment of human
immunodeficiency virus (HIV-1) infection in ART-experienced children aged
3 to 6 years and weighing at least 15 kg.
In the management of HIV-1 infection in children from the age of 6 years,
previously-treated adolescents and adults
The Committee considers that the proprietary medicinal product PREZISTA
oral solution, co-administered with a low-dose of ritonavir and other
antiretroviral agents is an addition to the range and does not therefore offer
any improvement in actual benefit: IAB V (non-existent) in the treatment of
human immunodeficiencyvirus in treatment-experienced children and
adolescents from the age of 6 years and in adults.
PREZISTA 75 mg, 150 mg, 300 mg and 600 mg, film-coated tablet
In the extension of indication for the tablet forms in the previously-treated
paediatric population aged from 3 to 6 years weighing between 15 and 20 kg,
the Committee considers that the medicinal product PREZISTA, co-
administered with a low dose of ritonavir and other antiretroviral agents,
constitutes a moderate improvement in actual benefit (IAB III) in the treatment
of human immunodeficiency virus (HIV-1) infection.