title: Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients.
abstract: Background. HIV protease inhibitors exhibit concentration-dependent viral inhibition. Higher once daily doses of darunavir boosted with ritonavir (DRV/r) may achieve viral suppression in place of twice daily dosing. International antiretroviral adherence guidelines recommend once daily regimens whenever possible. We present data on virologic suppression achieved with DRV 1,200 mg and ritonavir 100 mg once daily compared to approved DRV regimens. Methods. This retrospective observational study included all patients treated with DRV after documented use of another protease inhibitor at an urban immunodeficiency clinic. Data collection from inception of DRV use in August 2006 through March 2012 included patient demographics, viral loads, CD4+ cell counts, and resistance test results. The primary outcome of virologic suppression was defined as <50 copies/mL at 24 weeks. Differences in baseline characteristics and virologic outcomes across dosing groups were analyzed via one-way analysis of variance. Results. One hundred and thirty-five patients were included in the ITT analysis. Most patients had no known DRV RAMs at baseline. Virologic suppression rate was not different among treatment groups: 53.6% of patients on 1,200 mg daily, 52.3% on 600 mg twice daily, and 42.9% on 800 mg daily (P = 0.568). Conclusions. Darunavir 1,200 mg daily should be investigated for use in protease inhibitor-experienced patients.
authors: Immunodeficiency Services, Erie County Medical Center, 462 Grider Street, Buffalo, NY 14215, USA ; Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, 285 Kapoor Hall, Buffalo, NY 14214, USA ; Translational Pharmacology Research Core, New York State Center of Excellence in Bioinformatics and Life Sciences, 701 Ellicott Street, Buffalo, NY 14023, USA.
authors: James M
authors: JM
authors: Mikula
authors: Chiu-Bin
authors: CB
authors: Hsiao
authors: Joshua R
authors: JR
authors: Sawyer
authors: Qing
authors: Q
authors: Ma
authors: Gene D
authors: GD
authors: Morse
references: Antivir Ther. 2009;14(6):859-64
references: 19812449
references: AIDS Res Hum Retroviruses. 2010 Dec;26(12):1279-85
references: 20961276
references: AIDS Res Hum Retroviruses. 2008 Mar;24(3):379-88
references: 18327986
references: Clin Infect Dis. 2009 Nov 1;49(9):1441-9
references: 19814627
references: Ann Intern Med. 2012 Jun 5;156(11):817-33, W-284, W-285, W-286, W-287, W-288, W-289, W-290, W-291,
references: 22393036
references: Lancet Infect Dis. 2006 Apr;6(4):215-25
references: 16554246
references: Clin Infect Dis. 2010 Mar 15;50(6):872-81
references: 20158400
references: JAMA. 1981 Oct 2;246(14):1575-8
references: 7277631
references: Antimicrob Agents Chemother. 2008 Nov;52(11):3928-32
references: 18725446
references: Nat Med. 2008 Jul;14(7):762-6
references: 18552857
references: Ther Drug Monit. 2012 Jun;34(3):237-41
references: 22549499
references: AIDS. 2012 Mar 13;26(5):649-51
references: 22233654
references: AIDS. 2012 Mar 27;26(6):776-8
references: 22436541