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Efficacy and safety of sofosbuvir-based, interferon-free therapy

The Management of rheumatologic extrahepatic manifestations associated with chronic hepatitis C virus infection

Wirksamkeit und Sicherheit der Sofosbuvir-basierten Interferon-freien Therapie

Management rheumatologischer extrahepatischer Manifestationen in Zusammenhang mit chronischer Hepatitis-C-Virus-Infektion

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Abstract

Background

The use of pegylated interferon alpha (IFN) has been of concern in chronic hepatitis C virus (HCV) patients with rheumatologic extrahepatic manifestations (EHM) due to the immunostimulatory effects of IFN.

Aim

To study the efficacy and safety of sofosbuvir-based, IFN-free antiviral therapy in chronic HCV patients with rheumatologic EHM.

Material and methods

Group A included 24 patients with arthropathy (arthralgia or arthritis, n = 15) or vasculitis (n = 9) who received sofosbuvir and ribavirin (n = 17) or sofosbuvir and simeprevir (n = 7). Group B comprised 15 historical controls suffering from arthropathy who had received IFN and ribavirin. All patients were clinically evaluated and by detection of HCV viremia at baseline (V0), at the end of treatment (V1), 12 weeks after end of treatment (V2) and 24 weeks after end of treatment (V3).

Results

Sustained viral response was obtained in all patients of group A (100%) versus 12 out of 15 of group B (80%). In group A, the tender joint count (TJC) and visual analogue scale for pain (VAS) improved (p = 0.001 for both) while the swollen joint count (SJC) decreased at V1 (p = 0.001) but returned to baseline values at V3. All vasculitis patients improved. Purpura, arthralgia and leg ulcers disappeared, but peripheral neuropathy persisted. In group B, TJC, SJC and VAS increased from baseline values (p = 0.034, 0.03 and 0.001, respectively). Side effects in group A were generally mild, but one patient developed deterioration of arthralgia.

Conclusion

The use of IFN-free regimens is safe and effective in the treatment of most HCV-related rheumatologic EHM.

Zusammenfassung

Hintergrund

Die Verwendung von pegyliertem Interferon α (IFN) ist aufgrund seiner immunstimulierenden Effekte bei chronischen Hepatitis-C-Virus-Infektionen (HCV) für Patienten mit rheumatologischen extrahepatischen Manifestationen (EHM) von Bedeutung.

Ziel

Ziel dieser Studie war es, die Wirksamkeit und Sicherheit der Sofosbuvir-basierten, IFN-freien antiviralen Therapie bei Patienten mit rheumatologischer EHM zu untersuchen.

Material und Methoden

In Gruppe A wurden 24 Patienten eingeschlossen, die eine Arthropathie (Arthralgie oder Arthritis, n = 15) oder Vaskulitis (n = 9) hatten und Sofosbuvir und Ribavirin (n = 17) oder Sofosbuvir und Simeprevir (n = 7) erhielten. Gruppe B umfasste 15 historische Daten von Kontrollpersonen mit einer Arthropatie, die IFN und Ribavirin erhielten. Alle Patienten wurden klinisch und durch Feststellung einer HCV-Viruslast bei Baseline (V0), am Ende der Behandlung (V1), 12 Wochen nach Behandlungsende (V2) und 24 Wochen nach Behandlungsende (V3) evaluiert.

Ergebnisse

Ein anhaltendes virales Ansprechen wurde bei allen Patienten der Gruppe A (100 %) vs. 12 von 15 in Gruppe B (80 %) erreicht. In Gruppe A verbesserte sich der Tender Joint Count (TJC) sowie die visuelle Analogskala (VAS) für Schmerz (beide p = 0,001), während der Swollen Joint Count (SJC) bei V1 sank (p = 0,001), jedoch bei V3 zu den Ausgangswerten zurückging. Bei allen Vaskulitispatienten trat eine Verbesserung ein. Purpura, Arthralgie und Beinulzera verschwanden, aber periphere Neuropathien bestanden weiterhin. In Gruppe B stiegen der TJC, SJC und die VAS im Vergleich zu den Ausgangswerten (p = 0,034, 0,03 bzw. 0,001). Die Nebenwirkungen in Gruppe A waren im Allgemeinen gering, aber bei einem Patienten verschlechterte sich die Arthralgie.

Schlussfolgerung

Die Verwendung von IFN-freien Therapieregimen ist sicher und effektiv bei der Behandlung der meisten HCV-bezogenen rheumatologischen EHM.

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Authors and Affiliations

  1. Rheumatology and Rehabilitaion department and Endemic Medicine and Hepatogastroenterology department, Faculty of Medicine, Cairo University, Cairo, Egypt

    A. A. Shahin, H. S. Zayed, M. Said & S. A. Amer

  2. Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University, Cairo, Egypt

    A. A. Shahin

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  1. A. A. Shahin
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  2. H. S. Zayed
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  3. M. Said
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Correspondence to A. A. Shahin.

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A.A. Shahin, H.S. Zayed, M. Said and S.A. Amer declare that they have no competing interests.

This article does not contain any studies with human participants or animals performed by any of the authors.

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Shahin, A.A., Zayed, H.S., Said, M. et al. Efficacy and safety of sofosbuvir-based, interferon-free therapy. Z Rheumatol 77, 621–628 (2018). https://doi.org/10.1007/s00393-017-0356-7

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