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news.Tibotec Therapeutics said the US Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of Prezista (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMs).
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The revised dosing recommendation extends the same dosing already approved for treatment-naive patients – Prezista, co-administered with ritonavir in combination with other antiretroviral agents and with food, once-daily (800/100mg) – to treatment-experienced patients with no DRV RAMs.
The previously approved dosing recommendation for Prezista/ritonavir in treatment-experienced patients (patients who have taken HIV medications in the past) was Prezista/ritonavir 600/100 mg twice daily.
The approval of this revision is based on 48-week data from the ODIN (Once-daily Darunavir In treatment-experieNced patients) study.
ODIN evaluated the efficacy and safety of Prezista/ritonavir once daily vs. Prezista/ritonavir twice daily for the treatment of HIV-1 in treatment-experienced adult patients with no DRV RAMs (i.e., V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, or L89V).
Tibotec president Glenn Mattes said with this once-daily dosing recommendation, boosted Prezista is now a viable option for more treatment-experienced patients.