A Pharmacokinetic Study of the Proteus Ingestible Sensor Paves the Way for Clinical Trials of Anti-HIV Drugs



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The Proteus Digital Health Approach to Monitoring the Use of Sensor Pills Found Another Audience in the HIV Prevention Community

Among the data presented at of this week's International AIDS Conference in Amsterdam. trial that equipped Truvada (tenofovir / emtricitabine) Gilead Sciences HIV preventive drug with tracking technology. Here, researchers found that the drug equipped with a sensor was well received by most users and pharmacokinetically equivalent to Truvada alone, which paves the way for its potential use in clinical practice.

] means, yes, we can use [sensor-equipped Truvada] clinically, and we can use it in clinical trials, "Dr. Sara H. Browne, associate professor of clinical medicine at the University of California, Division of Infectious Diseases of the San Diego Department of Medicine, said at a press conference. "The results we present [are] are an example of how this technology can take longitudinal drug regimens, and you will be able to see the profile of a patient who takes his medication very regularly – that clearly does not need much support – and one whose medication pattern is much more chaotic and needs more support. "

Truvada is an oral pre-exposure prophylaxis (PrEP) treatment that is recommended to be taken daily for the prevention of HIV transmission.Although clinically effective, the performance of preventive therapy has varied when it is used. it is used in real-world scenarios primarily because of inconsistent adherence.In addition, it is particularly difficult to ensure the population's adherence to HIV / AIDS. AIDS due to treatment costs, comorbidities, risk perception and cultural stigma.

A tool like Proteus can help caregivers to confirm if they have ingested According to Browne, their oral PrEP prescriptions could be a substantial contribution to prevention efforts.

"There are a number of problems in [HIV prevention treatment adherence]. We really need reliable measurements that are based on the ingestion of drugs, "said Browne." Currently, clinical practice still relies heavily on self-reporting, which is patient recall. We must be able to have ways for health care workers to distinguish between those who need support and those who do not, so that we can distribute resources appropriately. [And] When we get that support, we really need support that comes in near real time. "

The first step in exploring this possibility is to determine whether the combination of the company's sensor and Truvada in a single body's ability to absorb treatment, explained Browne. In doing so, she and her colleagues enrolled 60 participants in PrEP research as part of a prospective single-arm trial, including 12 participants who had received treatment with Sensors underwent pharmacokinetic sampling at various times during their fourteenth day of treatment, as well as a similar sampling a day later after native PrEP.

Among these participants, Browne and his team found that the average concentration of Truvada's two ingredients was equivalent regardless of whether or not Proteus sensors were included in the pill.The researchers also noted that these values ​​were also in line with average concentration levels recorded in other medical documents. Finally, the digital treatment of PrEP was well received by the study participants, with 92% of them reporting a "positive experience" with the pill, the patch and the phone system.

These results open the door to a future investigation Browne noting that such an essay is already underway.

"Digital PrEP is available, and digital PrEP will allow real-time remote capture of medications for clinical use," she said. "This technology can provide longitudinal patterns of medication that can be used to facilitate differentiated care – and differentiated care, putting resources in the right place, will be crucial as we elevate PrEP."

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