A prospective study of direct-acting antiviral effectiveness and relapse risk in HCV cryoglobulinemic vasculitis by the Italian PITER cohort.


Journal

Hepatology (Baltimore, Md.)
ISSN: 1527-3350
Titre abrégé: Hepatology
Pays: United States
ID NLM: 8302946

Informations de publication

Date de publication:
07 2022
Historique:
revised: 27 10 2021
received: 27 07 2021
accepted: 08 12 2021
pubmed: 18 12 2021
medline: 22 6 2022
entrez: 17 12 2021
Statut: ppublish

Résumé

Mixed cryoglobulinemia is the most common HCV extrahepatic manifestation. We aimed to prospectively evaluate the cryoglobulinemic vasculitis (CV) clinical profile after a sustained virologic response (SVR) over a medium-term to long-term period. Direct-acting antiviral-treated cryoglobulinemic patients, consecutively enrolled in the multicentric Italian Platform for the Study of Viral Hepatitis Therapy cohort, were prospectively evaluated. Cumulative incidence Kaplan-Meier curves were reported for response, clinical deterioration, relapse and relapse-free survival rates. Cox regression analysis evaluated factors associated with different outcomes. A clinical response was reported in at least one follow-up point for 373 of 423 (88%) patients with CV who achieved SVR. Clinical response increased over time with a 76% improvement rate at month 12 after the end of treatment. A full complete response (FCR) was reached by 164 (38.8%) patients in at least one follow-up point. CV clinical response fluctuated, with some deterioration of the initial response in 49.6% of patients (median time of deterioration, 19 months). In patients who achieved FCR and had an available follow-up (137 patients) a relapse was observed in 13% and it was transient in 66.7% of patients. The rate of patients without any deterioration was 58% and 41% at 12 and 24 months, respectively. After achieving SVR, a clinical nonresponse was associated with older age and renal involvement; a clinical deterioration/relapse was associated with high pretreatment rheumatoid factor values, and FCR was inversely associated with age, neuropathy, and high cryocrit levels. In patients with CV, HCV eradication may not correspond to a persistent clinical improvement, and clinical response may fluctuate. This implies an attentive approach to post-SVR evaluation through prognostic factors and tailored treatment.

Sections du résumé

BACKGROUND AND AIMS
Mixed cryoglobulinemia is the most common HCV extrahepatic manifestation. We aimed to prospectively evaluate the cryoglobulinemic vasculitis (CV) clinical profile after a sustained virologic response (SVR) over a medium-term to long-term period.
APPROACH AND RESULTS
Direct-acting antiviral-treated cryoglobulinemic patients, consecutively enrolled in the multicentric Italian Platform for the Study of Viral Hepatitis Therapy cohort, were prospectively evaluated. Cumulative incidence Kaplan-Meier curves were reported for response, clinical deterioration, relapse and relapse-free survival rates. Cox regression analysis evaluated factors associated with different outcomes. A clinical response was reported in at least one follow-up point for 373 of 423 (88%) patients with CV who achieved SVR. Clinical response increased over time with a 76% improvement rate at month 12 after the end of treatment. A full complete response (FCR) was reached by 164 (38.8%) patients in at least one follow-up point. CV clinical response fluctuated, with some deterioration of the initial response in 49.6% of patients (median time of deterioration, 19 months). In patients who achieved FCR and had an available follow-up (137 patients) a relapse was observed in 13% and it was transient in 66.7% of patients. The rate of patients without any deterioration was 58% and 41% at 12 and 24 months, respectively. After achieving SVR, a clinical nonresponse was associated with older age and renal involvement; a clinical deterioration/relapse was associated with high pretreatment rheumatoid factor values, and FCR was inversely associated with age, neuropathy, and high cryocrit levels.
CONCLUSION
In patients with CV, HCV eradication may not correspond to a persistent clinical improvement, and clinical response may fluctuate. This implies an attentive approach to post-SVR evaluation through prognostic factors and tailored treatment.

Identifiants

pubmed: 34919289
doi: 10.1002/hep.32281
pmc: PMC9305531
doi:

Substances chimiques

Antiviral Agents 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

220-232

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2022 The Authors. Hepatology published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.

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Auteurs

Loreta A Kondili (LA)

Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.

Monica Monti (M)

Center for Systemic Manifestations of Hepatitis Viruses, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

Maria Giovanna Quaranta (MG)

Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.

Laura Gragnani (L)

Center for Systemic Manifestations of Hepatitis Viruses, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

Valentina Panetta (V)

L'altrastatistica srl, Consultancy & Training, Biostatistics office, Rome, Italy.

Giuseppina Brancaccio (G)

Department of Molecular Medicine, Infectious Diseases, University of Padua, Padua, Italy.

Cesare Mazzaro (C)

Clinical and Experimental Onco-Haematology Unit, IRCCS Centro di Riferimento Oncologico, Aviano, Pordenone, Italy.

Marcello Persico (M)

Internal Medicine and Hepatology Unit, Salerno University, Salerno, Italy.

Mario Masarone (M)

Internal Medicine and Hepatology Unit, Salerno University, Salerno, Italy.

Ivan Gentile (I)

Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Pietro Andreone (P)

Department of Internal Medicine, University of Modena and Reggio Emilia, Modena, Italy.

Salvatore Madonia (S)

Department of Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy.

Elisa Biliotti (E)

Infectious and Tropical Diseases Unit, Umberto I Hospital-"Sapienza" University, Rome, Italy.

Roberto Filomia (R)

Department of Internal Medicine, University Hospital of Messina, Messina, Italy.

Massimo Puoti (M)

Infectious Diseases Unit, Niguarda Hospital, Milan, Italy.

Anna Ludovica Fracanzani (AL)

General Medicine and Metabolic Diseases, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.

Diletta Laccabue (D)

Laboratory of Viral Immunopathology, Unit of Infectious Diseases and Hepatology, Azienda Ospedaliero-Universitaria di Parma, University of Parma, Parma, Italy.

Donatella Ieluzzi (D)

Liver Unit, University Hospital of Verona, Verona, Italy.

Carmine Coppola (C)

Department of Hepatology, Gragnano Hospital, Gragnano, Naples, Italy.

Maria Grazia Rumi (MG)

Hepatology Unit, San Giuseppe Hospital, Milan, Italy.

Antonio Benedetti (A)

Clinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy.

Gabriella Verucchi (G)

Clinic of Infectious Diseases and Microbiology Unit, Alma Mater Studiorum Bologna University, Bologna, Italy.

Barbara Coco (B)

Hepatology and Liver Physiopathology Laboratory and Internal Medicine, Department of Clinical and Experimental Medicine, University Hospital of Pisa, Pisa, Italy.

Liliana Chemello (L)

Unit of Internal Medicine and Hepatology-Clinica Medica 5, Department of Medicine-DIMED, University of Padua, Padua, Italy.

Andrea Iannone (A)

Gastroenterology Unit, University of Bari, Bari, Italy.

Alessia Ciancio (A)

Gastroenterology Unit, Città della Salute e della Scienza of Turin, University Hospital, Turin, Italy.

Francesco Paolo Russo (FP)

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.

Francesco Barbaro (F)

Infectious and Tropical Diseases Unit, University of Padua, Padua, Italy.

Filomena Morisco (F)

Gastroenterology Unit, Federico II University, Naples, Italy.

Luchino Chessa (L)

Liver Unit, University of Cagliari, Cagliari, Italy.

Marco Massari (M)

Infectious Diseases Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Pierluigi Blanc (P)

Infectious Disease Unit, Santa Maria Annunziata Hospital, Florence, Italy.

Anna Linda Zignego (AL)

Center for Systemic Manifestations of Hepatitis Viruses, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

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