[PMID]: | 28288791 |
[Au] Autor: | Saadoun D; Pol S; Ferfar Y; Alric L; Hezode C; Si Ahmed SN; de Saint Martin L; Comarmond C; Bouyer AS; Musset L; Poynard T; Resche Rigon M; Cacoub P |
[Ad] Endereço: | Sorbonne Universités, Université Pierre et Marie Curie University of Paris 06, Unité Médicale de Recherche 7211, Inflammation-Immunopathology-Biotherapy Department (Département Hospitalo Universitaire Inflammation, Immunopathology and Biotherapy), Paris, France; INSERM, Unité Médicale de Recherche_S |
[Ti] Título: | Efficacy and Safety of Sofosbuvir Plus Daclatasvir for Treatment of HCV-Associated Cryoglobulinemia Vasculitis. |
[So] Source: | Gastroenterology;153(1):49-52.e5, 2017 Jul. |
[Is] ISSN: | 1528-0012 |
[Cp] País de publicação: | United States |
[La] Idioma: | eng |
[Ab] Resumo: | Circulating mixed cryoglobulins are detected in 40%-60% of patients with hepatitis C virus (HCV) infection, and overt cryoglobulinemia vasculitis (CryoVas) develops in approximately 15% of patients. Remission of vasculitis has been associated with viral clearance, but few studies have reported the effectiveness of direct-acting antiviral drugs in these patients. We performed an open-label, prospective, multicenter study of the effectiveness and tolerance of an all-oral, interferon- and ribavirin-free regimen of sofosbuvir plus daclatasvir in patients with HCV-associated CryoVas. Forty-one consecutive patients with active HCV-associated CryoVas (median age, 56 y; 53.6% women) were recruited from hospitals in Paris, France, from 2014 through 2016. They received sofosbuvir (400 mg/day) plus daclatasvir (60 mg/day) for 12 weeks (n = 32) or 24 weeks (n = 9), and were evaluated every 4 weeks until week 24 and at week 36. Blood samples were analyzed for complete blood count, serum chemistry profile, level of alanine aminotransferase, rheumatoid factor activity, C4 fraction of complement, and cryoglobulin; peripheral blood mononuclear cells were isolated for flow cytometry analysis. Thirty-seven patients (90.2%) had a complete clinical response (defined by improvement of all the affected organs involved at baseline and no clinical relapse) after a median time of 12 weeks of therapy; all had a sustained virologic response (no detectable serum HCV RNA 12 weeks after the end of antiviral therapy). Patients' mean cryoglobulin level decreased from 0.56 ± 0.18 at baseline to 0.21 ± 0.14 g/L at week 36, and no cryoglobulin was detected in 50% of patients at this time point. After antiviral therapy, patients had increased numbers of T-regulatory cells, IgM+CD21-/low-memory B cells, CD4+CXCR5+ interleukin 21+ cells, and T-helper 17 cells, compared with before therapy. After a median follow-up period of 26 months (interquartile range, 20-30 mo), no patients had a serious adverse event or relapse of vasculitis. |
[Mh] Termos MeSH primário: |
Antivirais/uso terapêutico Crioglobulinemia/tratamento farmacológico Crioglobulinas/metabolismo Hepatite C/tratamento farmacológico Imidazóis/uso terapêutico Sofosbuvir/uso terapêutico Vasculite/tratamento farmacológico
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[Mh] Termos MeSH secundário: |
Antivirais/efeitos adversos Linfócitos B/química Linfócitos T CD4-Positivos/química Crioglobulinemia/sangue Crioglobulinemia/virologia Quimioterapia Combinada Feminino Hepatite C/sangue Hepatite C/complicações Seres Humanos Imidazóis/efeitos adversos Imunoglobulina M/análise Interleucinas/análise Contagem de Linfócitos Masculino Meia-Idade Estudos Prospectivos Receptores CXCR5/análise Receptores de Complemento 3d/análise Sofosbuvir/efeitos adversos Resposta Viral Sustentada Linfócitos T Reguladores Células Th17 Vasculite/sangue Vasculite/virologia
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[Pt] Tipo de publicação: | JOURNAL ARTICLE; MULTICENTER STUDY |
[Nm] Nome de substância:
| 0 (Antiviral Agents); 0 (BMS-790052); 0 (CXCR5 protein, human); 0 (Cryoglobulins); 0 (Imidazoles); 0 (Immunoglobulin M); 0 (Interleukins); 0 (Receptors, CXCR5); 0 (Receptors, Complement 3d); 0 (interleukin-21); WJ6CA3ZU8B (Sofosbuvir) |
[Em] Mês de entrada: | 1709 |
[Cu] Atualização por classe: | 170906 |
[Lr] Data última revisão:
| 170906 |
[Sb] Subgrupo de revista: | AIM; IM |
[Da] Data de entrada para processamento: | 170315 |
[St] Status: | MEDLINE |
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