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Dolutegravir (Tivicay)
National Drug Monograph
May 2014
VA Pharmacy Benefits Management Services,
Medical Advisory Panel, VISN Pharmacist Executives, and Office of Public Health
The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current.
Executive Summary:1-3
• Dolutegravir is an HIV integrase strand transfer inhibitor (INSTI). It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children ≥12 years old.
• The recommended dose in adults is 50mg once daily (for treatment-naïve or treatment-experienced patients who have never received an INSTI) or 50mg twice daily (for INSTI-experienced patients with certain INSTI-associated resistance substitutions or when coadministered with certain UGT1A/CY3A inducers in treatment-naïve or treatment-experienced INSTI-naïve).
• In a Phase 3 study, doultegravir based regimen was shown to be non-inferior to raltegravir based regimen in the proportion of treatment-naive patients achieving a HIV RNA ................
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