Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients

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 when...

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Main Authors: James M. Mikula, Chiu-Bin Hsiao, Joshua R. Sawyer, Qing Ma, Gene D. Morse
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:AIDS Research and Treatment
Online Access:http://dx.doi.org/10.1155/2013/687176
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author James M. Mikula
Chiu-Bin Hsiao
Joshua R. Sawyer
Qing Ma
Gene D. Morse
author_facet James M. Mikula
Chiu-Bin Hsiao
Joshua R. Sawyer
Qing Ma
Gene D. Morse
author_sort James M. Mikula
collection DOAJ
description 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.
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spelling doaj-art-fda256a183484de58170a2f577b5e0972025-02-03T01:11:18ZengWileyAIDS Research and Treatment2090-12402090-12592013-01-01201310.1155/2013/687176687176Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced PatientsJames M. Mikula0Chiu-Bin Hsiao1Joshua R. Sawyer2Qing Ma3Gene D. Morse4Immunodeficiency Services, Erie County Medical Center, 462 Grider Street, Buffalo, NY 14215, USAImmunodeficiency Services, Erie County Medical Center, 462 Grider Street, Buffalo, NY 14215, USAImmunodeficiency Services, Erie County Medical Center, 462 Grider Street, Buffalo, NY 14215, USADepartment of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, 285 Kapoor Hall, Buffalo, NY 14214, USADepartment of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, 285 Kapoor Hall, Buffalo, NY 14214, USABackground. 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.http://dx.doi.org/10.1155/2013/687176
spellingShingle James M. Mikula
Chiu-Bin Hsiao
Joshua R. Sawyer
Qing Ma
Gene D. Morse
Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients
AIDS Research and Treatment
title Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients
title_full Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients
title_fullStr Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients
title_full_unstemmed Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients
title_short Comparative Effectiveness of Darunavir 1,200 mg Daily and Approved Dosing Strategies for Protease Inhibitor-Experienced Patients
title_sort comparative effectiveness of darunavir 1 200 mg daily and approved dosing strategies for protease inhibitor experienced patients
url http://dx.doi.org/10.1155/2013/687176
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