The multi-center, single-arm, open-label study recorded an overall medication adherence rate of 93% alongside strong treatment outcomes.

HCV patients at risk of nonadherence using Proteus' digital pill achieve sustained viral clearance

By Dave Muoio
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A new study suggests that Proteus Digital Health’s sensor-embedded pills can improve adherence among Hepatitis C (HCV) patients who are at a high risk for nonadherence.

The data — presented this week at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting — indicate a 93% overall rate of medication adherence, and a 99.5% rate of sustained virologic response recorded up to 14 weeks after the therapy.

“Results suggest the [digital medicine program] may be used to support adherence and optimize cure rates in difficult to treat HCV populations,” the researchers wrote in the abstract.

TOPLINE DATA

The single-arm, open-label study was conducted across 18 US clinics by academic researchers and Proteus staff from late 2017 to early 2019. It followed 288 HCV patients considered likely to be nonadherence due to various risk factors — for instance, 68.4% had a household income under $25,000, 9.4% self-reported as homeless, 61% had a psychiatric disorder or substance abuse and 19% had HIV co-infection.

Of these participants, sustained virologic response testing results within one to 12 weeks after treatment were available for 205, and testing data up to 14 weeks after treatment available for 217. All participants in this first pool recorded a successful sustained virologic response, while 99.5% of those in the latter did the same. Mean adherence to the treatment, as observed wirelessly by Proteus’ system, was 93% across 200 participants in the first group for whom these data were recorded, and 93% again among the 212 participants with recorded adherence data in the longer-term group.

HOW IT WAS DONE

Researchers sought HCV patients with nonadherence factors who had access to a phone, and were capable of using a provided tablet device. Each was provided with Proteus’ platform, which consisted of: ingestible sensors housed alongside the patient’s direct acting antiviral medication, a sensor patch that is adhered to the skin and a connected mobile app.

Meanwhile, providers received updates on their patients’ adherence through a provider web portal, and reached out to the patients if they missed a dose. The primary outcomes of interest were sustained virologic response at four and 12 weeks post-treatment, as well as daily adherence as determined by the system.

THE LARGER TREND

HCV is one of several conditions that require daily oral medication to manage, and just the latest in a continuous stream of use cases for the digital adherence platform. Since the FDA approval of Abilify MyCite in late 2017, the company has seen deployments and promising study data employing the technology for HIV patients, heart transplant recipients, cancer patients and most recently tuberculosis patients. Additionally, the time since that approval has also seen the digital health company expand its long-standing relationship with Otsuka Pharmaceutical via a five-year, $88 million development and commercialization partnership.

ON THE RECORD

“This is encouraging data showing how ‘DigiMeds’ can make a significant impact on curing patients at high risk of nonadherence,” Andrew Thompson, CEO of Proteus Digital Health, said in a statement. “As we pursue the use of DigiMeds across therapeutic areas, we believe we will continue to see improved patient outcomes.”