JMIR Publications

ABSTRACT

Background:

A fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) is efficacious in treating chronic hepatitis C virus (HCV); however, objective adherence to prescribed regimens in real-world clinical settings has not been well-studied.

Objective:

The aim of the study was to evaluate adherence and virologic outcomes in chronically infected HCV patients treated with SOF/LDV and using a novel digital medicine program (DMP) that directly measures drug ingestion adherence.

Methods:

This prospective, observational, open-label, single-arm pilot study was conducted in two clinical research sites and followed HCV-infected patients who were prescribed sofosbuvir/ledipasvir along with the ingestible sensor. Patients were treated for 8 or 12 weeks. Main outcomes were ingestion adherence, medical interventions, virologic response, safety, and patient satisfaction.

Results:

All 28 patients (mean age ± SD: 59 ± 7 years, 61% male, 57% Non-Caucasians, 93% treatment-naïve) had genotype 1 HCV; 27 completed 8- or 12- weeks treatment. Patients used the DMP for 92% of expected days; overall mean adherence was 97%. Providers used the DMP data for same-day medication therapy management in 39% of patients. End-of-treatment response was achieved in all of the available 21 of 28 patients. Sustained virologic response at 12+ weeks was achieved in 26 of 28 patients; of the 2 who relapsed, one had <90% adherence and the other was ≥95% adherent, lending insights to reasons for treatment failure. Four subjects reported non-serious adverse events which were promptly resolved.

Conclusions:

These findings suggest that Digital Medicines can be used for wirelessly observed therapy to support adherence to anti-viral HCV therapy, reduce unnecessary medication wastage, retreatment costs, and potentially optimize SVR rates, especially in specific populations.