Treatment of Cryoglobulinemic Vasculitis with Sofosbuvir in Four Combination Protocols

Mohamed Tharwat Hegazy¹, Mohamed A Hussein¹, Luca Quartuccio², Mary Fawzy¹, Naguib Zoheir³, Mona I. Ellawindi⁴, Milena Bond², Cesare Mazzaro⁵, Ahmed El Ray⁶, Maissa El Said El Raziky^7,8, Magdy El Serafy⁹, Wahid Doss⁹, Patrice Cacoub¹⁰, Loïc Guillevin¹¹, Salvatore De Vita², Sherif El Khamisy¹² and Gaafar Ragab¹, ¹Internal Medicine, Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Cairo, Egypt, Cairo, Egypt, ²Rheumatology Clinic, DSMB, University of Udine, Udine, Italy, Udine, Italy, ³Clinical and Chemical Pathology Department, Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Cairo, Egypt, Cairo, Egypt, ⁴Community Medicine, Community Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt, Cairo, Egypt, ⁵Internal Medicine, Pordenone Hospital, Italy, pordenone, Italy, ⁶Theodor Bilharz Research Institute, Cairo, Egypt, Cairo, Egypt, ⁷Fatimid Cairo hospital, Cairo, Egypt, Cairo, Egypt, ⁸Tropical Medicine, Tropical Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt, cairo, Egypt, ⁹Tropical Medicine, Tropical Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt, Cairo, Egypt, ¹⁰Internal Medicine Department, University Hospital “Pitié-Salpêtrière”, “Pierre et Marie Curie Paris VI” University, Paris, France, ¹¹Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, Paris, France, ¹²Zewail city of Science and Technology, Egypt, Giza, Egypt

Meeting: ACR/ARHP Annual Meeting 2016

Date of first publication: September 28, 2016

Keywords: Cryoglobulinemia, Hepatitis C, treatment and vasculitis

Session Information

Date: Tuesday, November 15, 2016

Title: Vasculitis - Poster III: Rarer Vasculitides

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Cryoglobulinemic Vasculitis (CV) is a systemic vasculitis affecting small and medium-sized vessels. Following emergence of direct acting antiviral drugs, which paved the way to avoid both the side effects of immunosuppressive treatments; and also Interferon. The aim of our study was to assess the effect of Sofosbuvir in the treatment of HCV- CV manifestations

Methods: This is a multicenter interventional treatment trial, including 26 Egyptian patients and 9 Italian patients with CV, diagnosed according to the Classification criteria of Cryoglobulinemic Vasculitis, which were validated in 2014. Patients were treated with Sofosbuvir following four treatment protocols: 1- Sofosbuvir + Ribavirin for 6 months, 2- Sofosbuvir + Ribavirin + Interferon for 3 months, 3- Sofosbuvir + Daclatasvir for 3 months, and 4- Sofosbuvir + Simeprevir for 3 months. Clinical assessment (according to the Classification criteria of CV), cryocrit %, C4 serum level and serum level of rheumatoid factor (RF), were recorded soon before and at the end of the treatment. Response was assessed as complete, partial or absent (no response). Analytical procedures used were Pearson Chi-Square and Wilcoxon tests as indicated.

Results: 35 patients (24 females, mean age 56 ± 11 y) were enrolled in the study. Sixteen patients showed liver cirrhosis. All patients were Child- Pugh A stage. 13,8,5,9 patients were treated by first, second, third, fourth protocol, respectively. All patients showed a sustained viral response (SVR). All patients had purpura and all of them responded to treatment. 35 patients had Fatigue and 24 patients had fibromyalgia, 34, 22 patients responded respectively. 26 patients had arthralgia and 23 patients had non erosive arthritis, 22, 20 patients responded respectively. 13 patients had Raynaudˈs phenomenon and 2 patients had fibromyalgia, 12, 2 patients responded respectively after treatment. 25 patients had Peripheral poly neuropathy with total response after treatment in 21 patients. One of our patients had leg ulcer and mono- neuritis multiplex with complete response and completely healed ulcer after treatment. Nephritis was diagnosed in two patients, one of them had proteinuria and renal impairment and another one had proteinuria only, with total improvement of both by antiviral therapy alone. Serum level of Cryocrit (P value < 0.0001), RF (P value= 0.004), C4 (P value= 0.003), significantly decreased after treatment.

Conclusion: Antiviral combination therapy including Sofosbuvir appears very effective in the treatment of the most frequent CV manifestations. Since laboratory signs of CV improved but did not disappear, long-term clinical and biological effects of SVR by Sofosbuvir should be studied

Disclosure: M. T. Hegazy, None; M. A. Hussein, None; L. Quartuccio, None; M. Fawzy, None; N. Zoheir, None; M. I. Ellawindi, None; M. Bond, None; C. Mazzaro, None; A. El Ray, None; M. E. S. El Raziky, None; M. El Serafy, None; W. Doss, None; P. Cacoub, None; L. Guillevin, None; S. De Vita, None; S. El Khamisy, None; G. Ragab, None.

To cite this abstract in AMA style:

Hegazy MT, Hussein MA, Quartuccio L, Fawzy M, Zoheir N, Ellawindi MI, Bond M, Mazzaro C, El Ray A, El Raziky MES, El Serafy M, Doss W, Cacoub P, Guillevin L, De Vita S, El Khamisy S, Ragab G. Treatment of Cryoglobulinemic Vasculitis with Sofosbuvir in Four Combination Protocols [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/treatment-of-cryoglobulinemic-vasculitis-with-sofosbuvir-in-four-combination-protocols/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/treatment-of-cryoglobulinemic-vasculitis-with-sofosbuvir-in-four-combination-protocols/