Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia

Summary

10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with cirrhosis). The researchers anticipate that approximately 20% of subjects may have cirrhosis.

Timeline

Start

2016-02

Primary completion

2019-07-19

Completion

2019-07-19

Publications

• Background Dammacco F, Sansonno D. Therapy for hepatitis C virus-related cryoglobulinemic vasculitis. N Engl J Med. 2013 Sep 12;369(11):1035-45. doi: 10.1056/NEJMra1208642. No abstract available.
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• Background Dispenzieri A, Gorevic PD. Cryoglobulinemia. Hematol Oncol Clin North Am. 1999 Dec;13(6):1315-49. doi: 10.1016/s0889-8588(05)70129-5.
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• Background Wilson LE, Widman D, Dikman SH, Gorevic PD. Autoimmune disease complicating antiviral therapy for hepatitis C virus infection. Semin Arthritis Rheum. 2002 Dec;32(3):163-73. doi: 10.1053/sarh.2002.37277.
• Background Saadoun D, Resche Rigon M, Thibault V, Longuet M, Pol S, Blanc F, Pialoux G, Karras A, Bazin-Karra D, Cazorla C, Vittecoq D, Musset L, Decaux O, Ziza JM, Lambotte O, Cacoub P. Peg-IFNalpha/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24. Ann Rheum Dis. 2014 May;73(5):831-7. doi: 10.1136/annrheumdis-2012-202770. Epub 2013 Apr 20.
• Background Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, Shiffman ML, Schiff E, Ghalib R, Ryan M, Rustgi V, Chojkier M, Herring R, Di Bisceglie AM, Pockros PJ, Subramanian GM, An D, Svarovskaia E, Hyland RH, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Pound D, Fried MW; ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15;370(20):1879-88. doi: 10.1056/NEJMoa1402355. Epub 2014 Apr 10.
• Background Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.
• Background Levo Y, Gorevic PD, Kassab HJ, Tobias H, Franklin EC. Liver involvement in the syndrome of mixed cryoglobulinemia. Ann Intern Med. 1977 Sep;87(3):287-92. doi: 10.7326/0003-4819-87-3-287.
• Background Diagnosis and treatment of HCV-related mixed cryoglobulinemia over the last decade at a Liver Referral Center Ando, Y, Gorevic, PD, Schiano TD. Hepatology 58 2013 : 1443 abstract
• Background Naarendorp M, Kallemuchikkal U, Nuovo GJ, Gorevic PD. Longterm efficacy of interferon-alpha for extrahepatic disease associated with hepatitis C virus infection. J Rheumatol. 2001 Nov;28(11):2466-73.
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• Background Chen AY, Zeremski M, Chauhan R, Jacobson IM, Talal AH, Michalak TI. Persistence of hepatitis C virus during and after otherwise clinically successful treatment of chronic hepatitis C with standard pegylated interferon alpha-2b and ribavirin therapy. PLoS One. 2013 Nov 21;8(11):e80078. doi: 10.1371/journal.pone.0080078. eCollection 2013.
• Background Piluso A, Giannini C, Fognani E, Gragnani L, Caini P, Monti M, Petrarca A, Ranieri J, Urraro T, Triboli E, Laffi G, Zignego AL. Value of IL28B genotyping in patients with HCV-related mixed cryoglobulinemia: results of a large, prospective study. J Viral Hepat. 2013 Apr;20(4):e107-14. doi: 10.1111/jvh.12017. Epub 2012 Dec 4.
• Background Russi S, Sansonno D, Mariggio MA, Vinella A, Pavone F, Lauletta G, Sansonno S, Dammacco F. Assessment of total hepatitis C virus (HCV) core protein in HCV-related mixed cryoglobulinemia. Arthritis Res Ther. 2014 Mar 18;16(2):R73. doi: 10.1186/ar4513.
• Background Sansonno D, Tucci FA, Ghebrehiwet B, Lauletta G, Peerschke EI, Conteduca V, Russi S, Gatti P, Sansonno L, Dammacco F. Role of the receptor for the globular domain of C1q protein in the pathogenesis of hepatitis C virus-related cryoglobulin vascular damage. J Immunol. 2009 Nov 1;183(9):6013-20. doi: 10.4049/jimmunol.0902038. Epub 2009 Oct 14.
• Background Quartuccio L, Isola M, Corazza L, Ramos-Casals M, Retamozo S, Ragab GM, Zoheir MN, El-Menyawi MA, Salem MN, Sansonno D, Ferraccioli G, Gremese E, Tzioufas A, Voulgarelis M, Vassilopoulos D, Scarpato S, Pipitone N, Salvarani C, Guillevin L, Terrier B, Cacoub P, Filippini D, Saccardo F, Gabrielli A, Fraticelli P, Sebastiani M, Tomsic M, Tavoni A, Mazzaro C, Pioltelli P, Nishimoto N, Scaini P, Zignego AL, Ferri C, Monti G, Pietrogrande M, Bombardieri S, Galli M, De Vita S. Validation of the classification criteria for cryoglobulinaemic vasculitis. Rheumatology (Oxford). 2014 Dec;53(12):2209-13. doi: 10.1093/rheumatology/keu271. Epub 2014 Jul 3.
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• Background Gorevic, PD; "Mixed Cryoglobulinemia Cross-reactive Idiotypes: Structural and Clinical Significance" Cryoglobulinemia & Hepatitis C Infection, Dammacco, F (Editor); Springer Verlag, 2012, p. 99-107.
• Background Gorevic PD and Galanakis DK;

Drugs

Indications