Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct-acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence. Proteus is based in Redwood City, Calif. 

The high rate of adherence with the ingestible sensor-linked medication resulted in a 99% sustained virologic response in a study led by Mark Sulkowski, professor of medicine at Johns Hopkins University School of Medicine in Baltimore. The results were presented at the 2019 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in Boston. 

When a patient swallows the medication, the sensor sends a signal to a patch worn on the patient’s abdomen. The FDA-approved patch records the time the patient ingested the medication, as well as the individual’s heart rate, rest and activity patterns. All the captured information then is sent to an app on the patient’s mobile device that displays the person’s data to the health care team via a secure, web-based portal.  

“With the evidence from this study, our technology shows that Digimeds can be a useful tool to help facilitate greater adherence and therefore cure rates in the journey to eliminate HCV as a public health issue, especially for more vulnerable populations,” David Purdie, vice president of medical affairs and clinical development at Proteus, told BioWorld.  

About 2.4 million people in the U.S. have a diagnosis of HCV, with incidence rates tripling in the last decade as a result of the increase in use of injected drugs associated with the opioid epidemic, according to a recent study in JAMA Open Network. Another 1.2 million may be undiagnosed. While the infection will resolve on its own in up to 40% of cases, nearly half of those with chronic infection go on to develop progressive liver disease and face an increased risk of cirrhosis and hepatocellular carcinoma.  

Direct-acting antivirals (DAAs) produce sustained virological response (SVR) or cure the disease in more than 95% of adherent patients. The high cost of therapy, restrictions on providers who can oversee treatment, and limitations on patients who have demonstrated issues with adherence or substance use have limited treatment in the U.S. As a result, less than 37% of infected patients have been cured. 

The study 

The prospective, single-arm, open-label study enrolled 288 adults treated in 18 U.S. clinics with oral DAAs co-encapsulated with Digimeds.  

Eligible patients had at least one prespecified factor associated with increased risk of nonadherence, such as alcohol or substance use, hospitalization within the past two years for a psychiatric disorder, previous evidence on nonadherence, history of at least one missed clinic visit related to HCV management, or transportation barriers.  

Of the 61% who had a psychiatric disorder, 23% had serious mental illness and 52% had alcohol or substance use disorder. Most participants had household income below $25,000. 

The 95% adherence rate starkly contrasts to the 60% rate seen in similar populations in other studies. Patient satisfaction surveys indicated that four out of five respondents found the Digimeds system helped them keep track of their medication, feel connected to their care team, and remain motivated to achieve their treatment goals. 

“These patients are often perceived as being at risk for nonadherence, so in many cases, they are not even prescribed the curative HCV medications,” Purdie said. “By using digital medicines, patients were given access to these medications, were able to adhere to their regimen, and were ultimately cured.” 

The researchers obtained SVR outcome data on 235 participants. Of the 53 who had no serological outcomes available, 35 were lost to follow-up, 17 withdrew, and one had a phone follow-up without SVR assessment. 

“This lost to follow-up and withdrawal rate was not surprising, given that we enrolled a patient population that was already at high risk for not engaging with the health care system,” Purdie noted. 

By increasing adherence in difficult-to-treat populations, the Digimeds system may provide a way to reduce the overall burden of HCV. “When patients don’t receive access to medications or are not able to take their medications as prescribed, patients and health care systems are faced with unnecessary medical costs associated with worsening clinical outcome,” Purdie said. “Digimeds helps provide access, improve quality and outcomes of care, and reduce downstream medical expenses and total cost of care.”  

The Digimeds system has been used to treat colorectal cancer, hypertension, diabetes, high cholesterol, HIV and tuberculosis in clinical studies. 

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