Methods: This was a single-arm, prospective, open-label, pilot study at 2 sites. SOF/LDV tablets co-encapsulated with ingestible sensors allowed the DMP to record ingestion adherence rates (number of ingestions detected/number of expected ingestions). Other outcomes were medical interventions, SVR 12+ weeks after end of treatment, patient satisfaction, and safety.
Results: All 28 subjects (age 59 ± 7 years [mean ± SD], 61% male, 39% Caucasian, 93% treatment-naïve) had HCV genotype 1; 27 completed treatment. Most (82%) had <$25,000 income/year, 46% had psychiatric comorbidities, and 32% had a history of drug abuse. The DMP was used for 92% of expected days; mean ingestion adherence was 94%. Providers used the DMP data for same-day adherence interventions in 39% of patients. SVR was achieved in 26 of 28 subjects (2 had failed prior therapy). One subject who did not achieve SVR had high adherence (≥95%), suggesting viral resistance; the other was non-adherent (<90%). Most (92%) agreed the DMP helped them feel more involved in managing their healthcare and easy to use in their daily routine; 85% agreed the DMP helped them understand the importance of taking medications regularly. Four subjects reported 4 non-serious adverse events of rash/pruritus, which resolved and were consistent with use of adhesives.
Conclusion: These data suggest that the DMP may be used to support adherence to therapy through targeted, same-day adherence interventions, and optimize SVR rates, including in those with risk factors for nonadherence and in those who previously failed treatment.
Proteus Digital Health:
C. Pitney, Proteus Digital Health: Research Contractor , Research support .
L. McKoin, Proteus Digital Health: Research Contractor , Research support .
M. Tran, Proteus Digital Health: Employee , Salary .
C. Landis, Proteus Digital Health: Investigator , Research support .