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Safety and efficacy of a biodegradable implant releasing tenofovir alafenamide for vaginal protection in a macaque model.

I MassudA KroviK NishiuraS RuoneL LiA HolderJ GaryP MillsJ MitchellG KhalilY PanE LueckeG GattoW HeneineJ G Garcίa-LermaL JohnsonA van der StratenCharles W Dobard
Published in: The Journal of antimicrobial chemotherapy (2022)
We demonstrated complete protection against vaginal SHIV infection with two implants releasing a total of 0.7 mg of tenofovir alafenamide per day. We also identified tenofovir diphosphate concentrations in PBMCs associated with complete vaginal protection. Consistent with previous findings, we observed adverse local toxicity and necrosis near the tenofovir alafenamide implant site. Improved tenofovir alafenamide implants that are safe and maintain high efficacy have the potential to provide long-lasting protection against vaginal HIV infection.
Keyphrases
  • antiretroviral therapy
  • soft tissue
  • drug delivery
  • oxidative stress
  • emergency department
  • risk assessment