All Oral Interferon-Free Antivirals for Hepatitis C Virus Cryoglobulinemia Vasculitis: A Long Term Follow up Multicenter International Study

Patrice Cacoub¹, Si Nafa Si Ahmed², Yasmina FerFar³, SN Pol⁴, Dominique Thabut⁵, Christophe Hezode⁶, Laurent Albric⁷, Cloé Comarmond^8,9,10, Gafaar Ragab¹¹, Luca Quartuccio¹², Mohamed Hegazy¹³, Thierry Poynard⁵, Mathieu Resche-Rigon¹⁴ and David Saadoun¹⁵, ¹Department of Internal Medicine and Clinical Immunology, Groupe Hospitalier Pitié-Salpêtrière, Paris, France, ²Hôpital Orléans, Orléans, France, ³Internal Medicine, Hopital Pitié-Salpetrière, Paris, France, ⁴Department of Hepatology, APHP, Hôpital Cochin, Paris, paris, France, ⁵Groupe Hospitalier Pitié-Salpétrière, Paris, France, ⁶Hôpital Henri Mondor, Creteil, France, ⁷Centre hospitalier universitaire Purpan, Purpan, France, ⁸Internal Medicine and Clinical Imunology, Referal Center for Autoimmune diseases, Internal Medicine and Clinical Imunology, Hôpital Pitié Salpétrière, Paris, France, ⁹DHU 2iB Internal Medicine Referal Center for Autoimmune diseases Pitie Hospital, Paris, France, ¹⁰Internal Medicine, Hôpital Pitié Salpétrière, Paris, France, ¹¹Cairo University, Cairo, Egypt, ¹²University Hospital "Santa Maria della Misericordia, Udine, Italy, ¹³Faculty of Medicine – Cairo University, Cairo, El Salvador, ¹⁴Hôpital Saint-Louis, Paris, France, ¹⁵Sorbonne Universités, UPMC Univ Paris 06, UMR 7211, and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), F-75005, Paris, France; INSERM, UMR_S 959, F-75013, Paris, France; CNRS, FRE3632, F-75005, Paris, France; AP-HP, Groupe Hospitalier, Paris, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Hepatitis C, treatment and vasculitis

Session Information

Date: Sunday, November 5, 2017

Title: Vasculitis I: Clinical Trials and Outcomes

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Interferon (IFN) containing regimens used for hepatitis C virus (HCV)-cryoglobulinemia vasculitis (CryoVas) are poorly effective and associated with important side effects. In small-size and short term studies, direct antiviral agents (DAAs) have been reported to have a better response rate and tolerance. To evaluate effectiveness and tolerance of all oral IFN-free regimen in a real life – long term follow up – large cohort of symptomatic HCV-CryoVas patients.

Methods: 145 patients (57 years, 55% F) presenting symptomatic HCV-CryoVas who received DAAs, i.e. Sofosbuvir (SOF) plus Ribavirin (n=50), SOF plus Daclatasvir (n=49), SOF plus Ledipasvir (n=23), SOF plus Simeprevir (n=18), or other DAAs (n=5), for 12 or 24 weeks. Primary efficacy end point was a complete clinical response of CryoVas 12 weeks after stopping antivirals. Secondary endpoints: (i) sustained virological response (SVR12), (ii) tolerance of antivirals, and (iii) complete clinical response of CryoVas at the end of follow up.

Results: Baseline HCV-CryoVas features included arthralgia (64%), purpura (57%), neuropathy (58%), and glomerulonephritis (17%). Forty six (36%) patients had cirrhosis and 70 (48.3%) were naïve of antivirals. At 12 weeks post-DAAs, 103 (72%) showed a complete clinical response, 33 (23.1%) a partial response and 7 (4.9%) no response of CryoVas symptoms. Cryoglobulinemia disappeared in 53.1%. SVR12 was obtained in 97.1%. Premature DAAs withdrawal due to side effects was noted in 6 (4.1%). Main differences between patients with a complete response of the vasculitis (n=103) vs. partial/no response (n=40) were a severe form of CryoVas (65.1% vs 85%), arterial hypertension (22.3% vs. 45%), type 3 mixed cryoglobulinemia (31.3% vs. 9.1%), and use of immunosuppressant/plasma exchange (36.1% vs. 13.7%). The only factor that remained independently associated with a poor response was a severe form of CryoVas [OR 0.26, CI95% 0.07-0.98; P=0.04]. After a median follow-up of 15.3 months, 4 (2.8%) patients died. The 12-months survival rate was 97% [CI95% 94,100]. At the end of follow up, rates of CryoVas manifestations clearance were skin ulcers (98%), purpura (98%), renal involvement (92%), arthralgia (87%), neuropathy (78%) and cryoglobulinemia (54%). Rates of CryoVas complete remission at week12 post-treatment and at the end of follow up were for SOF plus Ribavirin 62% and 70%, SOF plus Simeprevir 67% and 72%, SOF plus Daclatasvir 78% and 88%, and SOF plus Ledipasvir 87% and 87%, respectively.

Conclusion: Sofosbuvir-based IFN-free DAAs combinations are highly effective in HCV-CryoVas patients in short term and long term, with a very good tolerance profile.

Disclosure: P. Cacoub, None; S. N. Si Ahmed, None; Y. FerFar, None; S. Pol, None; D. Thabut, None; C. Hezode, None; L. Albric, None; C. Comarmond, None; G. Ragab, None; L. Quartuccio, None; M. Hegazy, None; T. Poynard, None; M. Resche-Rigon, None; D. Saadoun, None.

To cite this abstract in AMA style:

Cacoub P, Si Ahmed SN, FerFar Y, Pol S, Thabut D, Hezode C, Albric L, Comarmond C, Ragab G, Quartuccio L, Hegazy M, Poynard T, Resche-Rigon M, Saadoun D. All Oral Interferon-Free Antivirals for Hepatitis C Virus Cryoglobulinemia Vasculitis: A Long Term Follow up Multicenter International Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/all-oral-interferon-free-antivirals-for-hepatitis-c-virus-cryoglobulinemia-vasculitis-a-long-term-follow-up-multicenter-international-study/. Accessed .

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