LB8. Microarray Patch Delivery of Long-Acting HIV PrEP and Contraception

BACKGROUND: The purpose of this research was to develop a microarray patch (MAP; also known as a microneedle patch) for delivery of long-acting cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) and co-delivery of long-acting CAB LA and a hormonal contraceptive to enable a future multi-purpose prevention technology. This abstract presents preclinical pharmacokinetic results of MAP delivery of CAB LA. METHODS: MAPs are an alternative delivery technology in clinical development for intradermal delivery of vaccines and pharmaceuticals. A MAP consists of an array of micron-scale projections (<1 mm in height) amassed on a baseplate and applied to the skin like a bandage. MAPs could provide a discreet delivery system that enables self-administration, which could be particularly important for HIV prevention and contraception for young women and girls in low-resource settings. The purpose of this 3-year, USAID-funded project is to develop a MAP for delivery of long-acting HIV PrEP through to the point of Phase I clinical readiness. Key attributes of the MAP for long-acting HIV PrEP, as defined by our target product profile, include patch size similar to commercially available transdermal patches (20 to 140 cm(2)), wear-time of less than 24 hours (ideally 20 minutes), weekly or monthly administration to achieve therapeutic efficacy, and ideally successful self-administration after reading simple product instructions. RESULTS: We successfully formulated and optimized MAP projection geometry to accommodate high drug-loading requirements of CAB LA (5.86 mg CAB LA per 1 cm(2) MAP), a hydrophobic drug. The MAPs are stable for 6 months under accelerated aging conditions in foil packaging, readily pierce the skin, and rapidly dissolve. In rats, plasma concentration levels of CAB LA were maintained above therapeutic targets of 4xPA-IC90 for 28 days; however, bioavailability was lower than IM or ID injection controls. Photos: QUB. MAPs dissolving over time in phosphate-buffered solution; MAP projections fully dissolved within 25 minutes. CONCLUSION: Additional development work is warranted, including optimizing bioavailability, evaluating MAPs as a maintenance dose in vivo, conducting cost of manufacturing and cost of delivery analyses, and assessing potential end-user acceptability. [Image: see text] [Image: see text] DISCLOSURES: Bill Spreen, PharmD, ViiV Healthcare (Employee), Trevor Scott, RPh, PhD, ViiV Healthcare (Employee). Others Authors: No reported disclosures.