Sofosbuvir Plus Ribavirin for Hepatitis C Virus Associated Cryoglobulinemia Vasculitis: Vascuvaldic Study

David Saadoun¹, V Thibault², L Alric³, C Guillaud⁴, H Izzedine², M Costopoulos², L Musset², H Fontaine⁵, C Hezode⁴, S Pol⁵, T Poynard², P Cacoub² and SN SI Ahmed⁶, ¹Department of Internal Medicine and clinical Immunology. French National Reference Center for Autoimmune Diseases. DHU I2B (Inflammation, Immunotherapy and Biotherapy), UPMC, Paris VI, Hôpital Pitié Salpétrière, AP-HP, UPMC, Univ Paris 06, Paris, France, ²CHU Pitie Salpetriere, Paris, France, ³CHU Toulouse, Toulouse, France, ⁴CHU H Mondor, Creteil, France, ⁵CHU Cochin, Paris, France, ⁶CH Orleans, Orleans, France

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Cryoglobulinemia, Hepatitis C, treatment and vasculitis

Session Information

Date: Tuesday, November 10, 2015

Title: Vasculitis IV

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Hepatitis C virus (HCV) is the etiologic agent for most cases of cryoglobulinemia vasculitis (Cryovas). Interferon–containing regimens are associated with important side effects and may exacerbate the vasculitis. We evaluated the safety and efficacy of an oral interferon-free regimen, sofosbuvir plus ribavirin, in patients with HCV-Cryovas.

Methods: We enrolled 24 patients [median age of 56.5 years and 46% of women] with HCV-Cryovas. Sofosbuvir (400mg/day) was associated to ribavirin (200-1,400mg/day), for 24 weeks. Selection of the initial ribavirin dose and subsequent dose modification for anemia were at the investigator’s discretion. The primary efficacy end point was a complete clinical response of the Cryovas at the end of treatment (week 24).

Results : Main clinical features of Cryovas included purpura and peripheral neuropathy (67%), arthralgia (58%), glomerulonephritis (21%), and skin ulcers (12%).Twenty one participants (87.5%) had a complete clinical response at week 24. Complete clinical response was achieved in 6 (25%) patients at week 4, 4 (16.6%) at week 8, 7 (29.2%) at week 12, 3 (12.5%) at week 16 and 1 (4.2%) at week 20. Purpura, skin ulcers and arthralgia disappeared in all cases. Kidney involvement improved in four out of five (80%) patients. Peripheral neuropathy improved in 16 out of 17 (94%) cases. 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 percent of patients had a sustained virological response at week 12 post treatment. The most common side effects were fatigue, insomnia and anemia. Two serious adverse events were observed leading to treatment discontinuation. Thirteen patients (54%) received erythropoietin and three required blood transfusion.

Conclusion: Treatment with sofosbuvir plus ribavirin for 24 weeks was associated with a high rate of complete clinical response and a low rate of serious adverse events among HCV-Cryovas patients.

Disclosure: D. Saadoun, Gilead, 5; V. Thibault, None; L. Alric, None; C. Guillaud, None; H. Izzedine, None; M. Costopoulos, None; L. Musset, None; H. Fontaine, None; C. Hezode, None; S. Pol, None; T. Poynard, None; P. Cacoub, Gilead, 5; S. SI Ahmed, None.

To cite this abstract in AMA style:

Saadoun D, Thibault V, Alric L, Guillaud C, Izzedine H, Costopoulos M, Musset L, Fontaine H, Hezode C, Pol S, Poynard T, Cacoub P, SI Ahmed S. Sofosbuvir Plus Ribavirin for Hepatitis C Virus Associated Cryoglobulinemia Vasculitis: Vascuvaldic Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/sofosbuvir-plus-ribavirin-for-hepatitis-c-virus-associated-cryoglobulinemia-vasculitis-vascuvaldic-study/. Accessed .

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