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CORRECTION - Janssen R&D Ireland: European Commission Approves PREZISTA® (darunavir) 800 Mg Tablet Once A Day Reducing The Number Of Pills Taken By People Living With HIV

i. ART-experienced adults with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10 6/l.

It is estimated that currently there are 34.5 million people living with HIV globally, with 2.5 million people becoming newly infected each year. [3]Thanks to significant advances in treatment for HIV over the past 30 years a diagnosis for these people is no longer a death sentence. Yet, data shows that after 8 months of treatment only 65% of patients will achieve 100% compliance. [4] Missing doses can allow drug levels in the blood to fall which could allow viral replication to occur and greatly increase the risk of resistance emerging. [5]

About PREZISTA® (darunavir)

Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients as well as antiretroviral therapy (ART) experienced paediatric patients from the age of 3 years and at least 15 kg body weight.

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) [ii] 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.

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