FDA Approves Once-Daily Darunavir for Certain Patients With HIV

Yael Waknine

December 15, 2010

December 15, 2010 — The US Food and Drug Administration (FDA) has approved once-daily dosing for darunavir (Prezista; Tibotec Pharmaceuticals, a division of Centocor Ortho Biotech Products, LP) boosted with ritonavir in treatment-experienced adult patients with HIV with no resistance to the protease inhibitor. Use of the darunavir/ritonavir 800 mg/100 mg once-daily regimen previously was restricted to treatment-naive patients.

"With this once-daily dosing recommendation, boosted Prezista is now a viable option for more treatment-experienced patients," said Glenn Mattes, president of Tibotec Therapeutics, in a company news release.

The new recommendation was based on 48-week data from the phase 3b Once-daily Darunavir In treatment-experieNced patients (ODIN) study of 590 patients with no darunavir resistance–associated mutations (V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, or L89V), a screening viral load of more than 1000 HIV-1 RNA copies/mL, and a CD4+ count higher than 50 cells/mm3.

Patients had been on highly active antiretroviral therapy for at least 12 weeks and were randomly assigned to receive darunavir once or twice daily with food and an optimized background regimen of 2 or more nucleoside reverse transcriptase inhibitors selected by investigators.

Results showed that darunavir/ritonavir 800 mg/100 mg once daily was similarly effective to the 600 mg/100 mg twice-daily regimen for achieving virologic response, defined as HIV-1 RNA levels lower than 50 copies/mL (69% for both). The mean increase from baseline in CD4+ cell count was likewise comparable between treatment groups (108 cells/mm3 vs 112 cells/mm3).

The FDA notes that patients with 1 or more darunavir resistance–associated mutation, and those for whom genotypic testing is not feasible, must continue taking darunavir/ritonavir 600 mg/100 mg twice daily.


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