OBJECTIVES: Centro Hospitalar e Universitário de Coimbra (CHUC) has developed a fully integrated clinical trials like system (CTLIKE) to cover and monitoring patients entering the universal access policy to direct-acting antivirals (DAA), starting in February 2015 in Portugal. The objective of this study is to assess this system effectiveness in terms of patients persistence on DAA therapy for hepatitis C in CHUC.

METHODS: This was an observational retrospective study covering the period Jan/2015-May/2018. CTLIKE is based on a set of day-to-day routines and protocols, supported by a dedicated software with the aim of controlling DAA dispensing and refiling and also therapy and patient outcomes monitoring, with the ultimate goal of capturing full benefit from Hepatitis C treatment for all stakeholders involved. CTLIKE is managed by the hospital pharmacy of CHUC. Efficiency of CTLIKE was assessed by measuring persistence, defined as remaining in therapy and not discontinuing (end of treatment). The Kaplan-Meier method was used for crude survival calculations. The risk of DAA treatment discontinuation was estimated by Cox proportional hazard models. Adherence was a second exploratory endpoint calculated by the pill count method.

RESULTS: The population included 721 patients with mean(SD) age 49.9(10.8) years and 76.0% male: Genotype 1 (70.8%); metavirF1 (33.3%); treatment naïve (69.5%). Sofosbuvir based regimens accounted for 94.7% of treatments. Planned treatment duration was: 12 weeks (73.6%); 24 weeks (26.4%). Premature treatment discontinuation before planned 12 and 24 weeks was estimated at 9.5% (95%CI: 6.9%-12.1%) and 20.4% (95%CI: 14.4%-26.0%), respectively. Men (HR discontinuation=0.85, 95%CI: 0.69-1.04) and non-cirrhotic patients (HR=0.73, 95%CI: 0.57-0.95) were more likely to persist on treatment. Adherence level ≥95% to DAA treatment occurred in 97.8% and 98.9% of 12 weeks and 24 weeks subgroups, respectively.

CONCLUSIONS: Very high persistence and adherence rates to DAA for hepatitis C treatment is confirmed by this real-world study.