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- W4313353609 abstract "Abstract The impact of pre-exposure prophylaxis (PrEP) on slowing the global human immunodeficiency virus (HIV) epidemic hinges on effective drugs and delivery platforms. Oral regimens have represented the pillar of HIV PrEP for years. However, variable adherence has spurred development of long-acting delivery systems, which also aim at increasing PrEP access, uptake and persistence. Here we present an ultra-long-acting and transcutaneously refillable subcutaneous nanofluidic implant for constant and sustained release of islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, for HIV PrEP. In rhesus macaques, the ISL-eluting implants (nISL) achieved constant plasma ISL levels (median 3.14 nM) and peripheral blood mononuclear cells (PBMCs) ISL-triphosphate levels (ISL-TP) (median 0.16 pmol/10 6 cells) for over 20 months uninterrupted. These drug concentrations are above the established PrEP protection threshold. In two non-blinded, placebo-controlled studies with repeated low-dose rectal and vaginal SHIV SF162P3 challenges in male and female rhesus macaques, respectively, nISL implants conferred 100% protection against infection ( p =0.0005 and 0.0009, respectively between nISL and placebo control groups). The nISL implants were well tolerated with mild local tissue inflammation and no signs of systemic toxicity over the 20-month period. Overall, our refillable nISL implant is a promising ultra-long-acting delivery technology for HIV PrEP. One Sentence Summary An ultra-long-acting and subcutaneous refillable nanofluidic implant achieved preventive levels of islatravir in non-human primates for 20 months without refilling and conferred 100% protection against rectal and vaginal SHIV transmission." @default.
- W4313353609 created "2023-01-06" @default.
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- W4313353609 date "2022-12-17" @default.
- W4313353609 modified "2023-10-16" @default.
- W4313353609 title "Ultra-long-acting refillable nanofluidic implant confers full protection against SHIV infection in non-human primates" @default.
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- W4313353609 doi "https://doi.org/10.1101/2022.12.15.520646" @default.
- W4313353609 hasPublicationYear "2022" @default.
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