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Prezista (darunavir) tablets have received an approval from the European Commission for treatment in combination with ritonavir of certain patients with human immunodeficiency virus (HIV-1).
Tibotec Pharmaceuticals announced that the EU has given the go-ahead for using the combination in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMS) who meet other criteria.
The revised dosing recommendation extends the same dosing already approved for treatment-naïve patients – darunavir, co-administered with ritonavir in combination with other antiretrovirals agents and with food, once-daily (800/100mg) – to treatment-experienced adult patients with no DRV RAMs and who meet other criteria.
Genotype testing should guide the use of darunavir in such treatment experienced adults.
“Tibotec and Janssen are committed to providing optimised dosing regimens for people living with HIV,” said Brian Woodfall MD, Vice President of Global Clinical Development at Tibotec.
“The extension of a once-daily dosing recommendation for darunavir to treatment-experienced patients will provide another viable option for this group.”
The approval of this revision is based on 48-week data from the ODIN (Once-daily Darunavir In treatment-experieNced patients) trial which evaluated the efficacy and safety of
800/100mg darunavir/ritonavir once-daily versus 600/100mg darunavir/ritonavir twice daily for the treatment of HIV-1 in treatment-experienced adult patients with no DRV RAMs.
Data from the Phase 3b ODIN trial were first presented at the 17th Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco in 2010.
The study achieved its primary objective of demonstrating non-inferiority of darunavir/ritonavir once-daily compared with twice-daily.
In December 2010, the U.S. Food and Drug Administration (FDA) approved this indication for use in the US.
Darunavir, a protease inhibitor, was developed by Tibotec Pharmaceuticals, an affiliate of Janssen one of the pharmaceutical companies of Johnson and Johnson, and the company responsible for marketing darunavir in Europe.