Pharmacokinetic study of Proteus' ingestible sensor paves way for clinical trials of HIV prevention drug

By Dave Muoio
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Proteus Digital Health’ pitch to track adherence using sensor-equipped pills has found another audience in the HIV prevention community.

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

“What this [study] means is, 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 in the University of California, San Diego Department of Medicine’s infectious disease division, said during a press conference. “The results we’re presenting [are] an example of how this technology can take longitudinal medication-taking patterns, and you’ll be able to see the pattern of a patient that takes their medication very regularly — who clearly doesn’t need a lot of support — and one whose medication-taking pattern is much more chaotic and would need more support.”

Truvada is an oral pre-exposure prophylaxis (PrEP) treatment that is recommended to be taken daily for the prevention of HIV transmission. While clinically effective, the preventive treatment’s performance has varied when used in real-world scenarios, primarily due to inconsistent adherence. Further, ensuring adherence among the HIV/AIDS population has proven especially difficult due to issues of treatment costs, comorbidities, perception of risk, and cultural stigma.

A tool like Proteus’ that can help caregivers confirm whether or not patients have ingested their oral PrEP prescriptions could prove a substantial boon to prevention efforts, Browne said.

“There are a number of problems in [HIV prevention treatment adherence]. We really need reliable measures that are based on medication ingestion,” Browne said. “Currently, clinical practice still relies mostly on self report, which is patient recall. We need to be able to have ways for healthcare workers to distinguish who needs support and who doesn’t 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 measuring whether combining the company’s sensor and Truvada in a single pill has any effect on the body’s ability to absorb the treatment, Browne explained. To do so, she and her colleagues enrolled 60 participants seeking PrEP into a prospective single-arm open-label trial. Of these, 12 participants who had received the sensor-equipped treatment underwent pharmacokinetic sampling at various time points on their fourteenth day of treatment, as well as similar sampling one day later after taking native PrEP.

Among these participants, Browne and her team found the average concentration of both Truvada’s ingredients to be equivalent regardless of whether Proteus’ sensors was or was not included in the pill. The researchers also noted that these values were also in line with mean concentration values recording in other medical literature. Finally, the digital PrEP treatment was well received by the study’s participants, with 92 percent reporting a “positive experience” with the pill, patch, and phone system.

These results open the door for future investigation of how sensor-equipped PrEP could impact outcomes among high-risk patients, with Browne noting that such a trial is already underway.

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