Outcomes and costs of treating hepatitis C patients with second-generation direct-acting antivirals: results from the German Hepatitis C-Registry

Abstract

Objective Chronic hepatitis C virus infection is associated with a significant health burden. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The introduction of direct-acting antivirals (DAA) has led to an increase in sustained virologic response rates (SVR), but is accompanied by higher treatment costs. The aim of this study was to assess the outcomes and costs of treating hepatitis C virus infected patients with DAAs in clinical practice in Germany. Patients and methods Data were derived from a noninterventional study including a pharmacoeconomic subset of 2673 patients with genotypes 1 and 3 who initiated and completed treatment between February 2014 and February 2017. Sociodemographic and clinical parameters as well as resource utilization were collected using a web-based data recording system. Costs were calculated using official remuneration schemes. Results The mean age of the patients was 54.6 years; 48% were men. 93.5% of all patients achieved an SVR. The average total treatment costs were €67 979 (€67 131 medication costs, €824 ambulatory care, €24 hospital costs). The average costs per SVR of €72 705 were calculated. Differences in SVR and costs according to genotype, treatment regimen, treatment experience, and cirrhosis were observed. Quality-of-life data showed no or a minimal decrease during treatment. Conclusion This analysis confirms high SVR rates for newly introduced DAAs in a real-world setting. Costs per SVR estimated are comparable to first-generation DAA. Given the fact that the costs for the currently used treatment regimens have declined, it can be assumed that the costs per SVR have also decreased. Our insight into real-world outcomes and costs can serve as a basis for a comparison with the mentioned newly introduced treatment regimens.

Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies

“…Since the introduction of first DAAs prices have significantly decreased. We assumed average treatment costs of 34,000 EUR reflecting recent costs developments [27, 28]. An annual price reduction of 4% for the DAA was also taken into account.…”

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

“…Adverse events (AE) may occur during HCV treatment. While previous German real-world studies showed that 70-90 % of patients receiving interferon-containing regimens had at least one nonsevere AE and 4-11 % had a severe AE during treatment [29,30], recent studies in patients receiving predominantly interferon-free regimens show non-severe AE (58 %) and severe AE (3 %) less frequently, confirming better tolerability of interferon-free regimens [12]. In our sample, which received predominantly interferon-free regimens, non-severe AE occurred in half of the sample and severe AE in 4 %.…”

“…The average pharmaceutical costs summed up to € 48 470, in a previous analysis (02/2014-02/2017) the costs amounted to € 67 131 [12]. The costs vary between cirrhosis-status (€ 42 530 for non-cirrhotic and € 60 802 for cirrhotic) and sub-populations (€ 49 282 for non-HIV-population and € 44 827 for HIV = infected and/or OST patients).…”

“…Overall, we observed an SVR rate of 95 % in our study population. A previous analysis of the registry data (02/2014-02/2017) showed a rate of 94 % [12]. The SVR rate varies concerning treatment regimen, cirrhosis status (96 % in non-cirrhotic patients and 93 % in cirrhotic patients) and in terms of subpopulations (93 % in HIV-infected and/or OST patients and 95 % in the non-HIV population).…”

Deutsches Hepatitis C-Register (DHC-R) – eine Zwischenbilanz 4 Jahre nach Zulassung direkt antiviraler Substanzen (DAAs)

“…Stringente Qualitätssicherungsmaßnahmen inklusive zentralem und Vor-Ort-Monitoring sowie die unabhängige Leitung unter dem Dach der Deutschen Leberstiftung in Zusammenarbeit mit dem Berufsverband Niedergelassener Gastroenterologen Deutschlands e. V. (bng) begründet die Wertigkeit der Befunde. In den letzten Jahren konnten neben zahlreichen Kongressbeiträgen bereits 13 Originalarbeiten publiziert werden, die einzelne HCV-Genotypen [9 -11], bestimmte Therapieregime [12,13], besondere Patientenpopulationen wie HCV/HIV ko-infizierte [14,15], substituierte [16], zur Transplantation gelistete [17] oder ältere Patienten [18] oder andere Fragestellungen (virolo-gische Befunde [19], Gesundheitsökonomie [20], Fibrosemarker [21]) behandelt haben. Die Hauptbefunde der hier vorgestellten aktuellen Gesamtauswertung lassen sich wie folgt zusammenfassen: (i) Die Patientencharakteristika im DHC-R haben sich in den letzten vier Jahren deutlich gewandelt, (ii) der Anteil von Patienten mit Leberzirrhose, die in Deutschland antiviral behandelt werden müssen, nimmt kontinuierlich ab; (iii) Patienten mit einer gleichzeitig bestehenden Substitutionsbehandlung und/oder Patienten nach aktivem Drogenkonsum nehmen einen immer größeren Anteil am Hepatitis-C-Kollektiv in Deutschland ein; (iv) die hohe Effektivität und Sicherheit der interferonfreien Therapie der Hepatitis C konnte im DHC-R und damit auch außerhalb von klinischen Studien eindrucksvoll bestätigt werden.…”