Innovative delivery implant for long-term PrEP administration

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A nanochannel delivery implant (NDI) can deliver pre-exposure prophylaxis (PrEP) antiretroviral (ARV) drugs subcutaneously, according to study results.

PrEP with ARVs can prevent HIV transmission effectively; however, issues with poor adherence, low accessibility, and multiple routes of HIV exposure present challenges. To combat these issues, the researchers developed a novel drug delivery device.

The NDI is a subcutaneously implantable device that delivers sustained and constant doses of tenofovir alafenamide and emtricitabine for HIV PrEP. It uses a silicon nanochannel membrane to control drug diffusion from the reservoir. Although many existing drug delivery implants have a finite dosage, the NDI has ports that allow for transcutaneous refills once the current medication is depleted.

When the device was tested in rhesus macaques, the NDI achieved sustained release of both tenofovir alafenamide and emtricitabine for 83 days.

The researchers found that clinically relevant preventive levels of tenofovir diphosphate were present as early as 3 days after NDI implantation.

“Sustained release of ARVs via the NDI implant could eliminate PrEP drug adherence issues and tailor to the needs of populations with limited access to PrEP drugs, such as adolescents and people at risk of HIV infection living in low-income countries,” the researchers at the Houston Methodist Research Institute (HMRI), Houston, wrote.

Because the NDI device is compatible with a wide array of drugs, it presents a novel treatment option that can be tested for a variety of treatments.

Abstract
Pre-exposure prophylaxis (PrEP) with antiretroviral (ARV) drugs are effective at preventing human immunodeficiency virus (HIV) transmission. However, implementation of PrEP presents significant challenges due to poor user adherence, low accessibility to ARVs and multiple routes of HIV exposure. To address these challenges, we developed the nanochannel delivery implant (NDI), a subcutaneously implantable device for sustained and constant delivery of tenofovir alafenamide (TAF) and emtricitabine (FTC) for HIV PrEP. Unlike existing drug delivery platforms with finite depots, the NDI incorporates ports allowing for transcutaneous refilling upon drug exhaustion. NDI-mediated drug delivery in rhesus macaques resulted in sustained release of both TAF and FTC for 83 days, as indicated by concentrations of TAF, FTC and their respectively metabolites in plasma, PBMCs, rectal mononuclear cells and tissues associated with HIV transmission. Notably, clinically relevant preventative levels of tenofovir diphosphate were achieved as early as 3 days after NDI implantation. We also demonstrated the feasibility of transcutaneous drug refilling to extend the duration of PrEP drug delivery in NHPs. Overall, the NDI represents an innovative strategy for long-term HIV PrEP administration in both developed and developing countries.

Authors
Corrine Ying, Xuan Chua, Priva Jain, Andrea Ballerini, Giacomo Bruno, Lyle Hood, Manas Gupte, Song Gao, Nicola Di Trani, Antonia Susnjar, Kathryn Shelton, Lane R Bushman, Marco Folci, Carly S Filgueira, Mark A Marzinke, Peter L Anderson, Ming Hu, Pramod Nehete, Roberto C Arduino, Jagannadha K Sastry, Allessandro Grattoni

Infectious Disease Advisor material
Journal of Controlled Release abstract


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