Impact of a digital medicine programme on hepatitis C treatment adherence and efficacy in adults at high risk for non‐adherence

Summary Background Direct‐acting anti‐virals (DAA) are highly effective for hepatitis C virus (HCV) treatment, but perceived risks of medication non‐adherence may restrict access to care. Digital medicine programme (DMP) has improved adherence and outcomes for some conditions. Aims To conduct a prospective, single‐arm, open‐label study across the United States to assess the impact of DMP on adherence and efficacy in adults with chronic HCV infection at high risk for non‐adherence. Methods Eligible participants were placed on the DMP to evaluate real‐time adherence; primary outcome was sustained virological response (SVR) at ≥10 weeks post‐treatment. Results Between August 2017 and April 2019, 288 participants (Medicaid, 64.9%; psychiatric disorders, 61.1%; homeless, 9.4%) received DAAs for 8‐12 weeks (sofosbuvir/velpatasvir or ledipasvir, 45%; glecaprevir/pibrentasvir, 55%). SVR was achieved in 99.1% of 218 participants who had HCV RNA assessed at ≥10 weeks post‐treatment; of the 70 participants who did not have SVR assessed, 17 had SVR4 with HCV RNA assessed at a median (IQR; interquartile range) 5.6 weeks (4.1, 7.9) post‐treatment; one completed treatment but did not have HCV RNA assessed, and 52 discontinued treatment early without assessment. Overall, the primary analysed participants (n = 218) actively used the DMP for median (range) 92.9% (12.5%, 100%) of their prescribed treatment time, and overall pill‐taking adherence was 95.0% (57.1%, 100%). Participants reported the programme was useful and easy to use through satisfaction surveys. Conclusions HCV treatment with DMP was accepted by patients and clinicians and may support HCV treatment outcomes among patients at high risk for treatment non‐adherence (Clinical trials.gov NCT03164902).