A novel edible sensor system to characterize antiretroviral therapy adherence

DESCRIPTION (provided by applicant): As many as 1.1 million Americans have been estimated to be living with HIV/AIDS1. Globally, the HIV pandemic is of immense proportions with 33 million people infected2. In the last decade, enormous advances have taken place with the institution of antiretroviral therapy (ART); HIV infection has been transformed from a terminal illness into a chronic disease for those successful in adherence to chronic ART. As with any chronic disease, adherence falls with time, and mayresult in virologic failure with resultant drug resistance. To date, an adequate monitoring tool for adherence is missing and clinicians are not able to define, a priori, which patients will be non-adherent until therapy fails and subsequent options are more limited. Although there are many methods used currently to confirm adherence to a medication, there is no gold standard other than Directly Observed Therapy (i.e., watching a patient swallow each dose of medication), which is too resource intensive,time consuming, and costly for broad use. Thus there remains an unmet need for a reliable tool that can accurately characterize and manage medication adherence. WORK TO DATE: The RaisinTM system, currently under development by Proteus Biomedical, Inc., is being designed to electronically confirm and promote adherence to pharmacologic therapy, in addition to tracking fundamental behaviors, such as sleep and exercise, and physiological parameters. The RaisinTM system consists of edible sensors made from minerals and metals in the human food chain, attached to a medication, and activated by the gastric fluids after swallowing. Once energized, the sensor communicates with a small wearable detector on the torso. The detector then wirelessly uploads its data toa computing device (i.e. a mobile phone or a computer) and subsequently a secure server, where it can be accessed by patients and patient-designated physicians, family members and/or caregivers. RESEARCH OBJECTIVES: In this proposal, the objectives areto successfully integrate the RaisinTM edible sensor with anti-retroviral medication (Atripla(R)) using an edible, pressure-sensitive adhesive and an edible ultrathin protective layer of film, demonstrate that the dissolution properties of RaisinTM sensor-enabled Atripla(R) tablets are not significantly impacted clinically when compared to standard Atripla(R) tablets, and demonstrate that the sensors exhibit similar activation metrics as previously validated form factors. Phase II studies will be designed to evaluate the feasibility of the RaisinTM system to characterize medication taking behavior and persistence in antiretroviral naove patients with HIV infection. Successful integration of the RaisinTM edible sensor with anti-retroviral medication will advance the development of the overall RaisinTM system that is intended ultimately to: integrate adherence, physiological metrics, laboratory data and subjective user input, allow patients to access and to share data with physicians, family membersand/or caregivers, for ready feedback to patients about medical adherence and for providing tailored management PUBLIC HEALTH RELEVANCE: The RaisinTM system, currently under development by Proteus Biomedical, Inc., is being designed to electronically confirm and promote adherence to pharmacologic therapy, in addition to tracking fundamental behaviors, such as sleep and exercise, and physiological parameters. By date- and time-stamping actual ingestions of oral medications instead of surrogate measures of ingestion, the RaisinTM system may afford patients and their healthcare providers the opportunity to assess actual responses to medications and adjust them based on real-time information. The RaisinTM system has the potential to be widely used indisease populations that require resource-intensive therapies, such as HIV treatment, to identify non- adherent patients and to allocate resources and interventions accordingly.