Direct acting antiviral treatment of chronic hepatitis C in Denmark: factors associated with and barriers to treatment initiation

Abstract

Objectives: We describe factors associated with and barriers to initiation of Direct Acting Antiviral (DAA) treatment in patients with chronic hepatitis C, who fulfill national fibrosis treatment guidelines in Denmark.

Materials and Methods: In this nationwide cohort study, we included patients with chronic hepatitis C from The Danish Database for Hepatitis B and C (DANHEP) who fulfilled fibrosis treatment criteria. Factors associated with treatment initiation and treatment failure were determined by logistic regression analyses. Medical records were reviewed from patients who fulfilled fibrosis treatment criteria, but did not initiate DAA treatment to determine the cause.

Results: In 344 (49%) of 700 patients, who fulfilled treatment criteria, factors associated with DAA treatment initiation were transmission by other routes than injecting drug use odds ratio (OR) 2.13 (CI: 1.38–3.28), previous treatment failure OR 2.58 (CI: 1.84–3.61) and ALT above upper limit of normal OR 1.60 (CI: 1.18–2.17). The most frequent reasons for not starting treatment among 356 (51%) patients were non-adherence to medical appointments (n = 107/30%) and ongoing substance use (n = 61/17%). Treatment failure with viral relapse occurred in 19 (5.5%) patients, who were more likely to have failed previous treatment OR 4.53 (CI: 1.59–12.91).

Conclusions: In this nationwide cohort study, we found non-adherence to medical appointments and active substance use to be major obstacles for DAA treatment initiation. Our findings highlight the need for interventions that can overcome these barriers and increase the number of patients who can initiate and benefit from curative DAA treatment.

Keywords:

• Direct Acting Antivirals
• DAA
• hepatitis C virus
• HCV
• factors associated with treatment
• barriers to treatment
• treatment initiation
• liver disease
• liver cancer

Acknowledgements

We thank all the patients who are enrolled in DANHEP and the staff at the participating clinical departments for their continuous support recording data in DANHEP. Thanks to statistician Thomas Kallemose, Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark, for his statistical advice.

Disclosure statement

C. Sølund, K. Schønning, H.B. Krarup, A. Ernst, S. Hallager, U. Fahnøe, M.S. Pedersen, A.G. Pedersen E. Bélard and J. Bukh have no financial disclosures or conflict of interests to declare. N. Weis has received money paid to her institution for being clinical investigator, member of advisory boards and lecturer for Abbvie, Bristol-Myers Squibb and Merck, and member of advisory board and lecturer for Gilead. A.L. Laursen is a member of advisory boards for Abbvie, Gliead and Merck. P.B. Christensen has received research grants from Abbvie, Gilead and Merck. J. Gerstoft has received money paid to his institution for Board membership, grands, lectures and educational material from Abbvie, BMS, Gilead, Merck, Janssen, Bohringer and Sanofi-Pasteur and Viiv. L.G. Madsen has been a member of advisory boards for Abbvie and Merck.

Additional information

Funding

This work was supported by PhD stipends from Faculty of Health and Medical Sciences, University of Copenhagen [C.S. and J.B.] and Roskilde University [M.P.], respectively, and by grants from Hvidovre Hospital Research Foundation, The Capital Region of Denmark’s Research Foundation [J.B.], the Innovation Fund Denmark [J.B.], the Novo Nordisk Foundation, and the Danish Research Council [N.W., J.B.] including an advanced Sapere Aude grant [J.B.]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.