Rates of sustained virological response 12 weeks after the scheduled end of direct‐acting antiviral (<scp>DAA</scp>)‐based hepatitis C virus (<scp>HCV</scp>) therapy from the National German <scp>HCV</scp> registry: does <scp>HIV</scp> coinfection impair the response to <scp>DAA</scp> combination therapy?

Bischoff, Jenny; Mauss, Stefan; Cordes, Christiane; Lutz, Thomas; Scholten, Stefan; Moll, A; Jager, HR; Cornberg, Markus; Manns, MP; Baumgarten, Axel; Rockstroh, JK

doi:10.1111/hiv.12579

Cited by 41 publications

(33 citation statements)

References 21 publications

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“…To date, in the German Hepatitis C Registry (DHC-R), more than 16 500 patients have been enrolled since 2014. Overall, 97 % of patients undergoing DAA-based antiviral therapies achieved SVR as reported previously [5][6][7][8][14][15][16]. However, characteristics and follow up of larger number of patients with treatment failure to a first course of DAA combination regimens are unknown.…”

Section: Introductionmentioning

confidence: 67%

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)

et al. 2020

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Background 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. Patients and methods 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. Results 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 %). Conclusions 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.

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Section: Introductionmentioning

confidence: 67%

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)

et al. 2020

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“…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.…”

Section: Diskussionunclassified

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

et al. 2019

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Zusammenfassung Einleitung In Deutschland sind mehr als 250 000 Patienten an einer chronischen Hepatitis C (CHC) erkrankt. Seit 2014 sind zahlreiche potente direkt antivirale Substanzen gegen HCV zugelassen worden. Ziel des Deutschen Hepatitis-C-Registers (DHC-R) ist es, die Epidemiologie und Versorgung von Patienten mit CHC abzubilden und die Effektivität und Sicherheit der neuen Behandlungsmöglichkeiten im Praxisalltag zu untersuchen. Methoden Das DHC-R ist eine prospektive, multizentrische, nicht interventionelle Registerstudie. Bundesweit sind 327 Zentren für die Dokumentation freigeschaltet. Alle in Deutschland zugelassenen Medikamente wurden im DHC-R dokumentiert. Für die aktuelle Auswertung wurden 4 Phasen unterschieden: 2/2014 bis 12/2014, 1/2015 bis 12/2015, 1/2016 bis 7/2017 und 8/2017 bis 7/2018. Ergebnisse Zwischen Februar 2014 und Juli 2018 wurden 12 170 Patienten in das Register eingeschlossen (61,3 % Männer), eine antivirale Therapie erhielten 11 268. Das Behandlungsalter sank von 52,3 (Phase 1) auf 49,3 Jahre (Phase 4), der Anteil der Behandelten mit einer Drogenanamnese nahm zu (von 26,9 auf 43,1 %). 2014 wurden viele Patienten mit Leberzirrhose (35,1 %) behandelt, deren Anteil im Verlauf deutlich abnahm (Phase 4: 16,5 %). Die HCV-Genotypenverteilung änderte sich im Zeitverlauf deutlich, zuletzt stieg der Anteil des HCV-Genotyps 3 (30 % in Phase 4). Die Ausheilungsrate (PP-Analyse) steigerte sich von 92,8 % im Jahre 2014 auf zuletzt 97,4 % bei sehr guter Verträglichkeit. Zusammenfassung Das DHC-R beschreibt die Versorgungssituation der Patienten mit CHC in Deutschland, zeigt epidemiologische Tendenzen auf und belegt die ausgezeichneten Behandlungsmöglichkeiten.

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“…Coinfection with HIV does not impact the effectiveness of HCV treatment: equally high SVR rates can be found in HIV/HCV-coinfected patients as in HCV-monoinfected patients. 64,65 Migrants from High-Prevalence Countries Due to risk factors such as HCV prevalence in their country of origin, countries visited during their journey as migrants, and the conditions they experienced during migration, immigrants and refugees (collectively referred to in this article as migrants) are at an elevated risk of being infected with HCV as well as having other health problems. Migrants often remain unidentified and thus untreated.…”

Section: Hiv/hcv-coinfected Peoplementioning

confidence: 99%

The Micro-Elimination Approach to Eliminating Hepatitis C: Strategic and Operational Considerations

et al. 2018

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The introduction of efficacious new hepatitis C virus (HCV) treatments galvanized the World Health Organization to define ambitious targets for eliminating HCV as a public health threat by 2030. Formidable obstacles to reaching this goal can best be overcome through a micro-elimination approach, which entails pursuing elimination goals in discrete populations through multi-stakeholder initiatives that tailor interventions to the needs of these populations. Micro-elimination is less daunting, less complex, and less costly than full-scale, country-level initiatives to eliminate HCV, and it can build momentum by producing small victories that inspire more ambitious efforts. The micro-elimination approach encourages stakeholders who are most knowledgeable about specific populations to engage with each other and also promotes the uptake of new models of care. Examples of micro-elimination target populations include medical patients, people who inject drugs, migrants, and prisoners, although candidate populations can be expected to vary greatly in different countries and subnational areas.

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Rates of sustained virological response 12 weeks after the scheduled end of direct‐acting antiviral (DAA)‐based hepatitis C virus (HCV) therapy from the National German HCV registry: does HIV coinfection impair the response to DAA combination therapy?

Abstract: We found high SVR12 rates in monoinfected as well as coinfected individuals. No differences were detected between the two subgroups regardless of whether there was accompanying liver cirrhosis or a shortened treatment duration.

Cited by 41 publications

References 21 publications

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)

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)

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

The Micro-Elimination Approach to Eliminating Hepatitis C: Strategic and Operational Considerations

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