Tibotec Therapeutics, a division of Centocor
Ortho Biotech Products, L.P., has announced that the 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).
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 (800/100
mg) – 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.
For antiretroviral treatment-experienced patients, genotypic testing is
recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir
600/100 mg twice daily dosing is recommended.
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).
“With this once-daily dosing recommendation, boosted PREZISTA is now a viable
option for more treatment-experienced patients,” said Glenn Mattes, president, Tibotec Therapeutics. “This
approval reflects Tibotec’s ongoing commitment to optimizing dosing strategies
for HIV patients.”
Data from the Phase 3b ODIN study were presented earlier this year at CROI
2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco. The study achieved its primary objective
of demonstrating non-inferiority of PREZISTA/ritonavir once daily compared with