PIN6 CLINICAL BENEFITS AND COST SAVINGS FROM IMPLEMENTING A SIMPLIFIED STRATEGY FOR GLECAPREVIR/PIBRENTASVIR (G/P) 8-WEEK TREATMENT IN NON-CIRRHOTIC NAÃVE PATIENTS WITH HEPATITIS C. THE JUST SIMPLE STUDY (REAL CLINICAL PRACTICE IN SPAIN).

Abstract

To assess real non-pharmacological direct costs associated with a simplified strategy (combining one-step diagnosis and low monitoring), to describe patient's profile, and to assess the effectiveness and safety of the direct-acting antivirals combination of G/P for Chronic Hepatitis-C (HCV) treatment in real life. Multicenter, retrospective study conducted in 12 hospitals. Adult naïve patients, without cirrhosis, GT 1-6, were HCV diagnosed in one-step and prescribed G/P 8-weeks between April and November 2018 with a plan of low monitoring (basal and 12 post-treatment visits) were included Individual costs were obtained from public databases and cost studies. 70 patients were included in the study. 48.6% were women with an average age of 53, 12.9% were GT3, the median score of fibrosis was 5.6 Kpa and median of FIB 4 was 1.23. The effectiveness of G/P was 100% (66/66) (ITTm) and 94.3% (66/70) (ITT). One patient prematurely discontinued treatment and no follow-up data were obtained in 3 patients. There were no discontinuations for G/P safety reasons, no serious adverse events, and no reported Grade 3 laboratory abnormalities. The estimated non-pharmacological direct costs of a traditional 8-weeks treatment strategy are 1,722-2,152 € (traditional diagnosis and 1 to 2 extra visits during the monitoring) and for a 12-weeks treatment between 2,152-2,582 € (traditional diagnosis and 2 to 3 extra visits). The actual average cost per patient treated was 1,146.51 € (± 151,44). 7.1% (5/70) used additional health resources to this strategy. In 68.5% of cases G/P medication was dispensed at more than one pharmacy visit. The treatment of hepatitis C with G/P 8 weeks allows to implement a simplified strategy in the patient evaluation and monitoring of the patient that leads to, among other benefits, substantial cost savings without affecting the effectiveness and safety observed with traditional strategies in other real-life studies.