David Saadoun1, Vincent Thibault2, Si Nafa Si Ahmed3, Laurent Alric4, Maxime Mallet5, Constance Guillaud6, Hassane Izzedine7, Aurélie Plaisier8, Hélène Fontaine9, Myrto Costopoulos10, Magali Le Garff-Tavernier10, Christophe Hezode11, Stanislas Pol9, Lucile Musset12, Thierry Poynard5, Patrice Cacoub1. 1. Inflammation-Immunopathology-Biotherapy Department (DHU i2B), Sorbonne Universités, UPMC Univ Paris 06, Paris, France INSERM, UMR_S 959, Paris, France CNRS, FRE3632, Paris, France Groupe Hospitalier Pitié-Salpêtrière, Department of Internal Medicine and Clinical Immunology, AP-HP, Paris, France. 2. Groupe Hospitalier Pitié-Salpétrière, Department of Virology, APHP, Paris, France. 3. Department of Hepatology, Hôpital Orléans, Orléans, France. 4. Department of Internal Medicine-Digestive, Centre hospitalier universitaire Purpan, UMR 152 Toulouse 3 University, Toulouse, France. 5. Groupe Hospitalier Pitié-Salpétrière, Department of Hepatology, AP-HP, Paris, France. 6. Department of Internal Medicine, Hôpital Henri Mondor, Créteil, France. 7. Groupe Hospitalier Pitié-Salpétrière, Department of Nephrology, APHP, Paris, France. 8. Department of Hepatology, APHP, Hôpital Beaujon, Clichy, France. 9. Department of Hepatology, APHP, Hôpital Cochin, Paris, France. 10. Groupe Hospitalier Pitié-Salpétrière, Biological Hematology, APHP, Paris, France. 11. Department of Hepatology, APHP, Hôpital Henri Mondor, Créteil, France. 12. Groupe Hospitalier Pitié-Salpétrière, Department of Immunology, UF d'Immunochimie et d'autoimmunité, APHP, Paris, France.
Abstract
BACKGROUND: Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinaemia vasculitis. Interferon-containing regimens are associated with important side effects and may exacerbate the vasculitis. OBJECTIVE: To evaluate safety and efficacy of an oral interferon-free regimen, sofosbuvir plus ribavirin, in HCV-cryoglobulinaemia vasculitis. PATIENTS AND METHODS: We enrolled 24 consecutive patients (median age of 56.5 years and 46% of women) with HCV-cryoglobulinaemia vasculitis. Sofosbuvir (400 mg/day) was associated with ribavirin (200-1400 mg/day), for 24 weeks. The primary efficacy end point was a complete clinical response of the vasculitis at the end of treatment (week 24). RESULTS: Main features of HCV-cryoglobulinaemia vasculitis included purpura and peripheral neuropathy (67%), arthralgia (58%), glomerulonephritis (21%) and skin ulcers (12%). Twenty-one patients (87.5%) were complete clinical response at week 24. Complete clinical response was achieved in six (25%) patients at week 4, four (16.6%) at week 8, seven (29.2%) at week 12, three (12.5%) at week 16 and one (4.2%) at week 20. The cryoglobulin level decreased from 0.35 (0.16-0.83) at baseline to 0.15 (0.05-0.45) g/L at week 24. The C4 serum level increased from 0.10 (0.07-0.19) to 0.17 (0.09-0.23) g/L at week 24. Seventy-four per cent of patients had a sustained virological response at week 12 post treatment. The most common side effects were fatigue, insomnia and anaemia. Two serious adverse events were observed. CONCLUSIONS: Sofosbuvir plus ribavirin combination was associated with a high rate of complete clinical response and a low rate of serious adverse events in HCV-cryoglobulinaemia vasculitis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
BACKGROUND:Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinaemia vasculitis. Interferon-containing regimens are associated with important side effects and may exacerbate the vasculitis. OBJECTIVE: To evaluate safety and efficacy of an oral interferon-free regimen, sofosbuvir plus ribavirin, in HCV-cryoglobulinaemia vasculitis. PATIENTS AND METHODS: We enrolled 24 consecutive patients (median age of 56.5 years and 46% of women) with HCV-cryoglobulinaemia vasculitis. Sofosbuvir (400 mg/day) was associated with ribavirin (200-1400 mg/day), for 24 weeks. The primary efficacy end point was a complete clinical response of the vasculitis at the end of treatment (week 24). RESULTS: Main features of HCV-cryoglobulinaemia vasculitis included purpura and peripheral neuropathy (67%), arthralgia (58%), glomerulonephritis (21%) and skin ulcers (12%). Twenty-one patients (87.5%) were complete clinical response at week 24. Complete clinical response was achieved in six (25%) patients at week 4, four (16.6%) at week 8, seven (29.2%) at week 12, three (12.5%) at week 16 and one (4.2%) at week 20. The cryoglobulin level decreased from 0.35 (0.16-0.83) at baseline to 0.15 (0.05-0.45) g/L at week 24. The C4 serum level increased from 0.10 (0.07-0.19) to 0.17 (0.09-0.23) g/L at week 24. Seventy-four per cent of patients had a sustained virological response at week 12 post treatment. The most common side effects were fatigue, insomnia and anaemia. Two serious adverse events were observed. CONCLUSIONS:Sofosbuvir plus ribavirin combination was associated with a high rate of complete clinical response and a low rate of serious adverse events in HCV-cryoglobulinaemia vasculitis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Authors: Hashem B El-Serag; Israel C Christie; Amy Puenpatom; Diana Castillo; Fasiha Kanwal; Jennifer R Kramer Journal: Aliment Pharmacol Ther Date: 2019-04-01 Impact factor: 8.171
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Authors: Massimo Andreoni; Sergio Babudieri; Savino Bruno; Massimo Colombo; Anna L Zignego; Vito Di Marco; Giovanni Di Perri; Carlo F Perno; Massimo Puoti; Gloria Taliani; Erica Villa; Antonio Craxì Journal: Infection Date: 2017-11-02 Impact factor: 3.553
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