Treatment-failure to direct antiviral HCV regimens in real world: frequency, patient characteristics and rescue therapy - data from the German hepatitis C registry (DHC-R) = Therapieversagen nach direkt antiviraler HCV-Therapie in Real-world : Häufigkeit, Patientencharakteristika und Rescue-Therapie–Daten aus dem Deutschen Hepatitis C-Register (DHC-R)
<p> <b>Background</b> Virologic failure to approved combinations of direct antiviral agents (DAA) in patients with chronic hepatitis C virus (HCV) infection is rare. Mostly it involves difficult to treat patients with advanced liver disease and prior interferon-experience. Before a...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article (Journal) |
| Language: | English German |
| Published: |
10. Februar 2020
|
| In: |
Zeitschrift für Gastroenterologie
Year: 2020, Volume: 58, Issue: 04, Pages: 341-351 |
| ISSN: | 1439-7803 |
| DOI: | 10.1055/a-1068-3056 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1055/a-1068-3056 Verlag, lizenzpflichtig, Volltext: http://www.thieme-connect.de/DOI/DOI?10.1055/a-1068-3056 
|
| Author Notes: | Annika Schmitt, Rainer Günther, Stefan Mauss, Klaus H. W. Boeker, Peter Buggisch, Heribert Hillenbrand, Christine John, Hartwig Klinker, Anita Pathil, Karl-Georg Simon, Yvonne Serfert, Claus Niederau, Johannes Vermehren, Heiner Wedemeyer, Christoph Sarrazin |
| Summary: | <p> <b>Background</b> Virologic failure to approved combinations of direct antiviral agents (DAA) in patients with chronic hepatitis C virus (HCV) infection is rare. Mostly it involves difficult to treat patients with advanced liver disease and prior interferon-experience. Before approval of VOX/VEL/SOF, a restricted number of patients received rescue treatment, and the choice of DAA combinations for re-treatment were selected on an individual basis. In the present analysis, patient characteristics and rescue-regimens after virologic failure mainly based on first generation DAAs are described.</p> <p> <b>Patients and methods</b> Data were obtained from the German Hepatitis C-Registry (DHC-R), which is a national multicenter real-world cohort currently including about 16 500 patients recruited by more than 250 centers. The present analysis is based on 6683 patients who initiated a DAA therapy and for whom follow-up data (per-protocol analysis) were available.</p> <p> <b>Results</b> Among the patients, 188 (2.8 %) experienced a virologic relapse. Compared to SVR-patients, relapse patients were significantly more often male (77.7 % versus 56.9 %, respectively, p < 0.001), showed cirrhosis significantly more (48.4 % versus 28.1 %, respectively, p < 0.001) and a prior interferon-containing therapy (46.3 % versus 39.0 %, respectively, p = 0.049). The majority of patients who relapsed were infected with genotype 1 (47.4 %) followed by genotype 3 (29.8 %), and 95 relapse patients started DAA re-treatment. Characteristics of patients with rescue-treatment are similar to these of patients with relapse after initial DAA treatment. Thirty-one of 39 patients with complete follow-up data achieved SVR (79.5 %), and 8 patients had a relapse again (20.5 %). Patients who received rescue treatment including a new DAA class according to guidelines, except patients who received VOX/VEL/SOF, showed higher SVR rates than the entire group (21/25, 84 %). All patients who received VOX/VEL/SOF achieved SVR (n = 4, 100 %).</p> <p> <b>Conclusions</b> Patients with failure with DAA combination therapies are a difficult but urgent to treat population with the frequent presence of cirrhosis and prior treatment failure with interferon-based therapies. Rescue therapy with inclusion of a new DAA class leads to high SVR rates, but multiple targeted therapy with VOX/VEL/SOF seems to be most effective.</p> |
|---|---|
| Item Description: | Gesehen am 02.07.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1439-7803 |
| DOI: | 10.1055/a-1068-3056 |