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

Abstract

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). | 1385 SULKOWSKI et aL.

Ingestible electronic sensors to measure instantaneous medication adherence: A narrative review

“…Of the 18 clinical trials that reported on the deployment of a DPS in human subjects, most were single-arm pilot studies ( n = 16). 22 , 24 – 30 , 32 , 34 – 39 , 43 Two were cluster-randomized pilot clinical trials among individuals with uncontrolled hypertension and diabetes. 31 , 33 All 18 investigations deployed the DPS with a primary endpoint of demonstrating the feasibility of their use in select patient populations where medication adherence is important.…”

“…While most of the pilot studies reviewed sought to define the feasibility of using a DPS in an indicated disease state, four focused on biological outcomes. 31 , 34 , 37 , 43 Two pilot investigations were conducted among individuals with hepatitis C, who used the DPS with either ledipasvir/sofosbuvir or glecaprevir/pibrentasvir or fosbuvir/velpatasvir. In the first study, all participants had preexisting risk factors for medication non-adherence.…”

“…The median rate of adherence to the DPS was 95%. 37 The primary outcome in the second study was the percentage of participants with greater than or equal to 95% medication ingestion adherence; a reported 89% ( n = 25) of participants achieved this benchmark. As a secondary outcome, the researchers also considered sustained virological response (SVR) and cure at 8 or 12 weeks, depending on each participant's treatment plan.…”

“…The majority additionally noted that the DPS was easy to operate on a daily basis and integrate into their existing routines. 27 , 31 , 32 , 34 , 35 , 37 , 38 , 43 Regarding the digital pills themselves, participants reported that the over encapsulation of their medications with a digital pill did not change the palatability of the pills nor prevent them from ingesting their medications as directed. 26 No studies reported DPS-related adverse events, except those using a cutaneous adherent patch as a receiver device 25 , 26 ; in these studies, investigators reported cases of minor skin reactions from the adhesive, which was described as superficial dermal irritation or a self-resolving rash.…”

“…in the context of antihypertensives), or help them to make individualized recommendations for their patients. 31 , 34 , 37 , 43 Qualitative studies have also demonstrated that healthcare providers are receptive to, and trusting of, data collected by DPS. 42 Despite this, it remains unclear how best to integrate DPS data into the arc of clinical care, including who should be primarily responsible for receiving and monitoring patients’ adherence data, as well as how best to respond to nonadherence events detected by DPS.…”