Ultra-long-acting removable drug delivery system for HIV treatment and prevention

Martina Kovarova (), S. Rahima Benhabbour, Ivana Massud, Rae Ann Spagnuolo, Brianna Skinner, Caroline E. Baker, Craig Sykes, Katie R. Mollan, Angela D. M. Kashuba, J. Gerardo García-Lerma, Russell J. Mumper and J. Victor Garcia ()
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Martina Kovarova: Center for AIDS Research, Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill
S. Rahima Benhabbour: UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
Ivana Massud: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention
Rae Ann Spagnuolo: Center for AIDS Research, Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill
Brianna Skinner: National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention
Caroline E. Baker: Center for AIDS Research, Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill
Craig Sykes: University of North Carolina at Chapel Hill
Katie R. Mollan: The University of North Carolina Center for AIDS Research
Angela D. M. Kashuba: University of North Carolina at Chapel Hill
J. Gerardo García-Lerma: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention
Russell J. Mumper: UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
J. Victor Garcia: Center for AIDS Research, Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill

Nature Communications, 2018, vol. 9, issue 1, 1-11

Abstract: Abstract Non-adherence to medication is an important health care problem, especially in the treatment of chronic conditions. Injectable long-acting (LA) formulations of antiretrovirals (ARVs) represent a viable alternative to improve adherence to HIV/AIDS treatment and prevention. However, the LA-ARV formulations currently in clinical trials cannot be removed after administration even if adverse events occur. Here we show an ultra-LA removable system that delivers drug for up to 9 months and can be safely removed to stop drug delivery. We use two pre-clinical models for HIV transmission and treatment, non-human primates (NHP) and humanized BLT (bone marrow/liver/thymus) mice and show a single dose of subcutaneously administered ultra-LA dolutegravir effectively delivers the drug in both models and show suppression of viremia and protection from multiple high-dose vaginal HIV challenges in BLT mice. This approach represents a potentially effective strategy for the ultra-LA drug delivery with multiple possible therapeutic applications.

Date: 2018
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DOI: 10.1038/s41467-018-06490-w

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