Realworld Evidence For Improvement Of Clinical Symptoms And Wellbeing Of Ost Patients After Ifn-Free Sofosbuvir– Based Regimen Therapy: Dhc-R Data

Author: Stefan Christensen, Renate Heyne, Uwe Naumann, Rainer Günther, Karl-Georg Simon, Christoph Herold, Hjördis Möller, Ulrich Bohr, Mehtap Gündogdu, Jens Reimer

Theme: Clinical Research Year: 2017

Background: OST patients in Germany have a higher HCV prevalence compared to other risk groups. Since the introduction of new direct acting antivirals (DAAs) in 2014 the therapy of chronic HCV has evolved rapidly. Data from real world cohorts could confirm the high cure rates (SVR 12) achieved in clinical trials. However, only limited data are available showing the impact of DAA mediated SVR on wellbeing and clinical symptoms of OST patients. Aim of this analysis was to understand the impact of SVR12 on Patient-Reported-Outcomes (PRO, based on SF-36 questionnaires), and on clinical symptoms (e.g. fatigue, muscle pain) in patients with and without OST.
Methods: The DHC-R is a national, multicenter study in Germany. Patients are treated at physicians’ discretion and data is collected using a web based system. This analysis is based on data of 703 patients, treated with IFN-free SOF-based regimens between the period of February 1st 2014 and June 30 2016 and achieved SVR12. Only patients with available SF-36 and clinical symptoms at baseline (BL) and week 24 (w24) after end of DAA treatment (EOT) were considered for this analysis (OST: n=53, Non-OST: n= 650). SF-36 subscale raw data were transformed into”0-100 score” (best value 100, worst 0); resulting values were z-transformed using regression coefficient and summed up according to affiliation.
Results: Wellbeing of OST patients show strong improvements from BL to w24 after EOT. Beside clinical symptoms such as fatigue different PROs improved between baseline and w24 of the follow-up phase as well. Both patient groups showed improved values in different categories at week 24 after EOT.
Conclusion: For the first time the positive effects of DAA mediated cure on clinical symptoms and wellbeing of OST compared to Non-OST patients under real world conditions were shown.

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