CC BY-NC-ND 4.0 · Z Gastroenterol 2023; 61(05): 489-503
DOI: 10.1055/a-1852-5713
Originalarbeit

Real‐world experience for the outcomes and costs of treating hepatitis C patients: Results from the German Hepatitis C-Registry (DHC-R)

Outcomes und Kosten der Behandlung von Hepatitis-C-Patienten in der medizinischen Praxis: Ergebnisse aus dem Deutschen Hepatitis-C-Register (DHC-R)
Kathrin Krüger
1   Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany (Ringgold ID: RIN9177)
,
Siegbert Rossol
2   Medizinische Klinik, Krankenhaus Nordwest, Frankfurt, Germany (Ringgold ID: RIN9152)
,
Christian Krauth
1   Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany (Ringgold ID: RIN9177)
,
Peter Buggisch
3   ifi-Institut für interdisziplinäre Medizin, Hamburg, Germany
,
Stefan Mauss
4   Center for HIV and Hepatogastroenterology, Duesseldorf, Germany
,
Albrecht Stoehr
3   ifi-Institut für interdisziplinäre Medizin, Hamburg, Germany
,
Hartwig Klinker
5   University Hospital Würzburg, Würzburg, Germany
,
Klaus Böker
6   Leberpraxis Hannover, Hannover, Germany
,
Gerlinde Teuber
7   MVZ Frankfurt, Frankfurt am Main, Germany
,
Jona Stahmeyer
1   Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany (Ringgold ID: RIN9177)
› Author Affiliations
The German Hepatitis C-Registry is financially supported by AbbVie Deutschland GmbH & Co. KG, Gilead Sciences GmbH, MSD Sharp & Dohme GmbH as well as Bristol-Myers Squibb GmbH & Co. KGaA and Janssen-Cilag GmbH (each until 2020-07-14) and Roche Pharma AG (until 2017-07-14).

Abstract

Background & Aims With long-term consequences like the development of liver cirrhosis and hepatocellular carcinoma, chronic hepatitis C virus (HCV) infection is associated with a significant health burden. Information on HCV treatment outcomes and costs in routine care is still rare, especially for subgroups. The aim of this study was to analyse the treatment outcomes and costs of subgroups in routine care and to compare them over time with previous analyses.

Methods Data were derived from a noninterventional study including a subset of 10298 patients receiving DAAs with genotypes 1 and 3. Sociodemographic, clinical parameters and costs were collected using a web-based data recording system. The total sample was subdivided according to treatment regimen, cirrhosis status as well as present HIV infection and opioid substitution treatment (OST).

Results 95% of all patients achieved SVR. Currently used DAA showed higher SVR-rates and less adverse events (AE) compared to former treatments. Concerning subgroups, cirrhotic patients, HIV-coinfected patients and OST patients showed lower but still high SVR-rates. In comparison, cirrhotic had considerably longer treatment duration and more frequent (serious) AE. Overall, average treatment costs were €48470 and costs per SVR were €51129; for currently used DAAs costs amounted to €30330 and costs per SVR to €31692. After the end of treatment, physical health is similar to the general population in all patients except cirrhotic. Mental health remains far behind in all subgroups, even for currently used DAA.

Conclusions Over time, some relevant factors developed positively (SVR-rates, costs, treatment duration, adverse events, health-related quality of life (HRQoL)). Further research on HRQoL, especially on mental health, is necessary to evaluate the differences between subgroups and HRQoL over time and to identify influencing factors.

Zusammenfassung

Hintergrund und Ziele Die chronische Infektion mit dem Hepatitis-C-Virus (HCV) ist mit Langzeitfolgen wie der Entwicklung einer Leberzirrhose oder eines hepatozellulären Karzinoms assoziiert und stellt eine erhebliche Gesundheitsbelastung dar. Informationen über HCV-Behandlungsergebnisse und -kosten in der Praxis sind nach wie vor rar, insbesondere für Subgruppen. Ziel dieser Studie war es, die Behandlungsergebnisse und -kosten von Subgruppen in der Versorgung zu analysieren und sie mit früheren Analysen zu vergleichen.

Methoden Die Daten stammen aus einer nicht interventionellen Studie mit einer Untergruppe von 10298 Patient*innen, die DAA erhalten und die Genotypen 1 und 3 aufweisen. Soziodemografische und klinische Parameter sowie Kosten wurden mithilfe eines webbasierten Datenerfassungssystems erhoben. Für die Analysen wurden verschiedene Subgruppen definiert: Die Gesamtstichprobe wurde nach Zirrhosestatus und nach vorhandener HIV-Infektion und Opioidsubstitutionsbehandlung (OST) unterteilt.

Ergebnisse 95 % aller Patienten erreichten eine SVR. Die derzeit verwendeten DAA wiesen im Vergleich zu früheren Behandlungen höhere SVR-Raten und weniger unerwünschte Ereignisse (AE) auf. Was die Untergruppen betrifft, so wiesen zirrhotische Patienten, HIV-Koinfizierte und OST-Patienten niedrigere, aber immer noch hohe SVR-Raten auf. Im Vergleich dazu hatten Zirrhotiker eine deutlich längere Behandlungsdauer und häufiger (schwere) Nebenwirkungen. Insgesamt beliefen sich die durchschnittlichen Behandlungskosten auf 48470 € und die Kosten pro SVR auf 51129 €; für die derzeit verwendeten DAAs beliefen sich die Kosten auf 30330 € und die Kosten pro SVR auf 31692 €. Nach Abschluss der Behandlung ist der körperliche Gesundheitszustand bei allen Patienten mit Ausnahme der Zirrhotiker mit dem der Allgemeinbevölkerung vergleichbar. Die psychische Gesundheit bleibt in allen Untergruppen weit zurück, selbst bei derzeit verwendeten DAA.

Schlussfolgerungen Im Laufe der Zeit entwickelten sich einige relevante Faktoren positiv (SVR-Raten, Kosten, Behandlungsdauer, unerwünschte Ereignisse, gesundheitsbezogene Lebensqualität [HRQoL]). Weitere Forschung zur HRQoL, insbesondere zur psychischen Gesundheit, ist erforderlich, um die Unterschiede zwischen den Subgruppen und die HRQoL im Zeitverlauf zu bewerten und Einflussfaktoren zu identifizieren.



Publication History

Received: 29 October 2021

Accepted after revision: 15 April 2022

Article published online:
15 July 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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  • References

  • 1 World Health Organization. Guidelines for the screening, care and treatment of persons with hepatitis C infection. 2014
  • 2 Poethko-Müller C, Zimmermann R, Hamouda O. et al. Die Seroepidemiologie der Hepatitis A, B und C in Deutschland. Bundesgesundheitsbl 2013; 56: 707-715
  • 3 Bruggmann P, Berg T, Øvrehus ALH. et al. Historical epidemiology of hepatitis C virus (HCV) in selected countries. Journal of Viral Hepatitis 2014; 21 (Suppl. 01) 5-33
  • 4 Pawlotsky J. New Hepatitis C Therapies: The Toolbox, Strategies, and Challenges. Gastroenterology 2014; 146: 1176-1192
  • 5 Mathurin P. HCV burden in Europe and the possible impact of current treatment. Digestive and liver disease: official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 2013; 45: S314-S317
  • 6 Perz JF, Armstrong GL, Farrington LA. et al. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. Journal of Hepatology 2006; 45: 529-538
  • 7 Dutkowski P, Linecker M, DeOliveira ML. et al. Challenges to liver transplantation and strategies to improve outcomes. Gastroenterology 2015; 148: 307-323
  • 8 Innes HA, McDonald SA, Dillon JF. et al. Toward a more complete understanding of the association between a hepatitis C sustained viral response and cause-specific outcomes. Hepatology (Baltimore, Md.) 2015; 62: 355-364
  • 9 van der Meer AJ, Veldt BJ, Feld JJ. et al. Association Between Sustained Virological Response and All-Cause Mortality Among Patients With Chronic Hepatitis C and Advanced Hepatic Fibrosis. JAMA 2012; 308: 2584
  • 10 Sarkar S, Jiang Z, Evon DM. et al. Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study. Journal of Hepatology 2012; 57: 946-952
  • 11 Drysdale K, Ntuli Y, Bestwick J. et al. English hepatitis C registry data show high response rates to directly acting anti-virals, even if treatment is not completed. Aliment Pharmacol Ther 2020; 52: 168-181
  • 12 Krüger K, Krauth C, Rossol S. et al. Outcomes and costs of treating hepatitis C patients with second-generation direct-acting antivirals: results from the German Hepatitis C-Registry. European Journal of Gastroenterology & Hepatology 2019; 31: 230-240
  • 13 Krauth C, Rossol S, Ortsäter G. et al. Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies. BMC Infect Dis 2019; 19: 529
  • 14 World Health Organization. Accelerating access to hepatitis C diagnostics and treatment: overcoming barriers in low- and middle-income countries. Global progress report 2020. 2021
  • 15 Hüppe D, Serfert Y, Buggisch P. et al. Deutsches Hepatitis C-Register (DHC-R) – eine Zwischenbilanz 4 Jahre nach Zulassung direkt antiviraler Substanzen (DAAs). Z Gastroenterol 2019; 57: 27-36
  • 16 Berg T, Naumann U, Stoehr A. et al. Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C infection: data from the German Hepatitis C-Registry. Aliment Pharmacol Ther 2019; 49: 1052-1059
  • 17 Christensen S, Buggisch P, Mauss S. et al. Direct-acting antiviral treatment of chronic HCV-infected patients on opioid substitution therapy: Still a concern in clinical practice?. Addiction 2018; 113: 868-882
  • 18 Maasoumy B, Buggisch P, Mauss S. et al. Clinical significance of detectable and quantifiable HCV RNA at the end of treatment with ledipasvir/sofosbuvir in GT1 patients. Liver Int 2018; 38: 1906-1910
  • 19 Dultz G, Müller T, Petersen J. et al. Effectiveness and Safety of Direct-Acting Antiviral Combination Therapies for Treatment of Hepatitis C Virus in Elderly Patients: Results from the German Hepatitis C Registry. Drugs Aging 2018; 35: 843-857
  • 20 Höner zu Siederdissen C, Schlevogt B, Solbach P. et al. Real-world effect of ribavirin on quality of life in HCV-infected patients receiving interferon-free treatment. Liver Int 2018; 38: 834-841
  • 21 Tacke F, Boeker KH, Klinker H. et al. Baseline risk factors determine lack of biochemical response after SVR in chronic hepatitis C patients treated with DAAs. Liver Int 2019; 40: 539-548
  • 22 LAUER-FISCHER GmbH. Lauer-Taxe Online/German Drug Directory. 2020
  • 23 Bullinger M, Kirchberger I. Der SF- 36 Fragebogen zum Gesundheitszustand – Handanweisung. Göttingen: Horgrefe; 1998
  • 24 Montes ML, Olveira A, Ahumada A. et al. Similar effectiveness of direct-acting antiviral against hepatitis C virus in patients with and without HIV infection. AIDS 2017; 31: 1253-1260
  • 25 Graf C, Mücke MM, Dultz G. et al. Efficacy of Direct-acting Antivirals for Chronic Hepatitis C Virus Infection in People Who Inject Drugs or Receive Opioid Substitution Therapy: A Systematic Review and Meta-analysis. Clinical Infectious Diseases 2020; 70: 2355-2365
  • 26 Macken L, Gelson W, Priest M. et al. Efficacy of direct-acting antivirals: UK real-world data from a well-characterised predominantly cirrhotic HCV cohort. J Med Virol 2019; 91: 1979-1988
  • 27 Zimmermann T, Jansen P, Sarrazin C. et al. S3-Leitlinie „Prophylaxe, Diagnostik und Therapie der Hepatitis-C-Virus (HCV) -Infektion“. Z Gastroenterol 2018; 56: e53-e115
  • 28 Simon KG, Serfert Y, Buggisch P. et al. Hepatitis C-Register D: Evolution of hepatitis C virus genotype 1a vs. 1b distribution reflects profound changes of HCV epidemiology in Germany between 2004 and 2018 – Analysis of 17093 patients from five consecutive registries including the German Hepatitis C-Registry (DHC-R).
  • 29 Stahmeyer JT, Krauth C, Bert F. et al. Costs and outcomes of treating chronic hepatitis C patients in routine care – results from a nationwide multicenter trial. Journal of Viral Hepatitis 2015; 23: 105-115
  • 30 Stahmeyer JT, Rossol S, Bert F. et al. Outcomes and Costs of Treating Hepatitis C Patients in the Era of First Generation Protease Inhibitors – Results from the PAN Study. PloS one 2016; 11: e0159976
  • 31 Krüger K, Krauth C, Rossol S. et al. Outcomes and costs of treating hepatitis C patients with second-generation direct-acting antivirals: results from the German Hepatitis C-registry. European Journal of Gastroenterology & Hepatology 2018;
  • 32 Siebert U, Ravens-Sieberer U, Greiner W. et al. Performance of different utility assessment methods in chronic hepatitis C patients. In Proceedings of the 19th Plenary Meeting of the EuroQol Group 13th-14th September 2002 Discussion Papers. In: Kind P, Macran S. . York: UK Centre for Health Economics; 2003: 175-184
  • 33 Stahmeyer JT, Rossol S, Liersch S. et al. Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany. PLoS ONE 2017; 12: e0169401
  • 34 Kracht PM, Lieveld FI, Amelung LM de. et al. The Impact of Hepatitis C Virus Direct-Acting Antivirals on Patient-Reported Outcomes: A Dutch Prospective Cohort Study. Infect Dis Ther 2018; 7: 373-385
  • 35 Jang ES, Kim YS, Kim K. et al. Factors Associated with Health-Related Quality of Life in Korean Patients with Chronic Hepatitis C Infection Using the SF-36 and EQ-5D. Gut and Liver 2018; 12: 440-448