Tibotec Therapeutics announced that Prezista (darunavir) has been approved for once-daily administration in combination with ritonavir for treating human immunodeficiency virus (HIV-1) in treatment-experienced adults with no darunavir resistance-associated mutations (DRV RAMs). Dosing recommendations now extend the same dosing already approved for treatment-naïve patients – Prezista/ritonavir 800/100mg once daily in combination with other antiretroviral agents – to treatment-experienced patients with no DRV RAMs. The previously approved dosing recommendation in treatment-experienced patients was Prezista/ritonavir 600/100mg twice daily.
This approval was based on data from ODIN, a Phase 3b randomized, open-label study which demonstrated that Prezista/ritonavir 800/100mg once daily was non-inferior to Prezista/ritonavir 600/100mg twice daily at week 48 in 590 treatment-experienced HIV-1-infected adult patients with no DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V).
For more information call (877) REACH-TT or visit www.prezista.com.