XV-122 Provides Ultra-long acting Dolutegravir Exposure in Rhesus Macaques

Arpan Acharya – Asst Professor, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center; Debapriya Sutar – Graduate Research Asst, University of Nebraska Medical Center; Brady Sillman – Asst Professor, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center; Samiksha Raut – Graduate Research Asst, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center; Nam Thai Hoang Le – Research Coordinator, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center; Brandon Hanson – Research Technologist II, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center; Brian Kearney – Chief Scientific and Development Officer, Exavir Therapeutics Inc.; Alborz Yazdi – Chief Executive Officer, Exavir Therapeutics Inc.; Siddappa Byrareddy – Professor, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center; Howard Gendelman – Professor, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center; Benson Edagwa – Professor, Pharmacology & Experimental Neuroscience, University of Nebraska Medical Center

Introduction:

Long-acting (LA) antiretroviral therapies (ART) have improved patient outcomes in HIV prevention and treatment. Ultra-long acting (ULA) ART offers less frequent dosing and greater convenience. A prodrug nanosuspension (XV-122) of homodimeric dolutegravir (DTG) was developed to meet next-generation needs. DTG is a potent integrase inhibitor with a high resistance barrier. In rodents, XV-122 maintained therapeutic levels for up to four months after a single IM or SC injection. This study demonstrates the ULA PK profile of XV-122 in rhesus macaques.