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Abstract

Introduction Tacrolimus-based drugs are of the mostly used immunosuppressants after liver transplantation (LT). Therapy adherence and dose adjustment play a key role in achieving the desired blood level and therefore treatment success. This is the first study which prospectively evaluates the patients’ therapy adherence as well as the need for adjustment of therapeutic doses of Tacrolimus after LT. Methods This is a pilot, prospective, exploratory, monocentric, noninterventional, and non-randomized investigator-initiated study (ClinicalTrials.gov: NCT04444817). Fifty consecutive patients receiving de novo LT who treated with oral Tacrolimus-based immunosuppressants were included. Patients’ therapy adherence, number of required dose adjustments for achieving the target trough level, and efficacy and safety data were evaluated. Results Thirty patients received once daily Tacrolimus (Envarsus®), and in 20 patients, twice daily Tacrolimus (Prograf®). The mean age of the patients was 54±9.9 years, and 24 patients (48%) were males. The mean number of dose adjustments per patient was 5 times in both groups. Six-months after LT, the mean Tacrolimus trough level in Prograf® group (7.5±7 µg/l) was 1.5- fold higher than the upper limit, whereas the mean Tacrolimus trough level in patients receiving Envarsus® (5.1±2 µg/l) was slightly higher than the therapeutic range. The rate of 8 treatment conversion to cyclosporine (4 patients (13.3%) in Envarsus group and 2 patients (10%) in Prograf group) was not significantly different between two treatment regimens (p-value=0.30). Except for serum levels of bilirubin, other markers including transaminases, liver function test, and renal function test did not differ between the two types of tacrolimus. During the study, there were no complaints or difficulties regarding adherence in either patient group and all patients adhered to immunosuppressant therapy. No significant difference was seen between two groups treated with Envarsus® (two deaths (4.5%)) and Prograf® (no death, p-value>0.05) regarding mortality. Conclusion There are no significant differences in patient adherence, number of dose adjunstments and safety between once-daily or twice-daily Tacrolimus administration.