Volume 34, Issue 7 pp. e217-e228
Viral Hepatitis

In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions

Alessandra Mangia

Corresponding Author

Alessandra Mangia

Liver Unit, IRCCS Hospital ‘Casa Sollievo della Sofferenza’, San Giovanni Rotondo, Italy

Correspondence

Alessandra Mangia, Liver Unit, IRCCS Hospital ‘Casa Sollievo della Sofferenza’, 71013 San Giovanni Rotondo, Italy

Tel: +11 39 8 8241 6270

Fax: +11 39 8 8241 6271

e-mail: [email protected]

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Tivadar Bányai

Tivadar Bányai

Department of Infectology, Pándy Kálmán Hospital, Gyula, Hungary

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Giuseppe De Bartolomeo

Giuseppe De Bartolomeo

Internal Medicine Liver Unit Hospital, F. Veneziale, Isernia, Italy

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Judit Gervain

Judit Gervain

Department of Internal Medicine/Hepatology and Molecular Diagnostic laboratories, Szent Gyorgy Hospital, Székesfehérvár, Hungary

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François Habersetzer

François Habersetzer

Pôle Hépato-digestif, Inserm 1110, Université de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France

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Jean-Pierre Mulkay

Jean-Pierre Mulkay

Hepato-gastroenterology, CHU Saint-Pierre, Brussels, Belgium

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Denis Ouzan

Denis Ouzan

Institut Arnault Tzanck, Saint-Laurent-du-Var, France

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Giustino Parruti

Giustino Parruti

Infectious Disease Unit, Santo Spirito General Hospital, Pescara, Italy

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Nicola Passariello

Nicola Passariello

Department of Geriatrics and Metabolic Diseases, University of Naples, Naples, Italy

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Andre-Jean Remy

Andre-Jean Remy

Centre Hospitalier de Perpignan, Perpignan, France

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Mario Rizzetto

Mario Rizzetto

University of Turin, Turin, Italy

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Mitchell L. Shiffman

Mitchell L. Shiffman

Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport News, VA, USA

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Alan D. Tice

Alan D. Tice

Infections Limited Hawaii, Honolulu, HI, USA

In memoriam.Search for more papers by this author
Manuela Schmitz

Manuela Schmitz

IST GmbH, Mannheim, Germany

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Fernando Tatsch

Fernando Tatsch

F. Hoffmann-La Roche Ltd, Basel, Switzerland

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Maribel Rodriguez-Torres

Maribel Rodriguez-Torres

Fundación de Investigación, San Juan, PR, USA

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First published: 06 October 2013
Citations: 1

Abstract

Background & Aims

PROPHESYS is a large, multinational, non-interventional prospective cohort study of chronic hepatitis C patients treated with peginterferon alfa/ribavirin. This subanalysis assesses rates of premature treatment discontinuation stratified by on-treatment virological response (VR).

Methods

This PROPHESYS subanalysis is restricted to treatment-naive, hepatitis C virus (HCV) genotype (G)1/2/3 mono-infected patients who received peginterferon alfa-2a (40KD)/ribavirin with intended treatment duration of 48 (G1) or 24 weeks (G2/3). Early virological responses were classified into four mutually exclusive categories [rapid VR (RVR), complete early VR (cEVR), partial EVR (pEVR), no RVR/EVR], using standard criteria.

Results

The likelihood for shortening treatment owing to good efficacy was highest among patients with an RVR and HCV RNA ≤400 000 IU/ml (G1 10.0%; G2/3 5.8%) whereas for poor efficacy, it was highest in G1 non-RVR/EVR patients with HCV RNA >400 000 IU/ml (56.6%). Factors significantly associated with early treatment discontinuation as a result of good efficacy in G1 patients included RVR vs. no RVR/EVR and, at baseline, lower HCV RNA, lower FIB-4 score, HCV infection via injection drug use. For G2/3 patients, factors included lower baseline HCV RNA and G2 vs. G3 infection. Most patients started with the recommended peginterferon alfa-2a dose, but a high proportion received a higher-than-recommended ribavirin dose.

Conclusions

Despite international guidelines, few physicians used early viral kinetics to abbreviate treatment. Therefore, relatively few patients with an RVR and low baseline HCV RNA abbreviated treatment. In addition, there were deviations in ribavirin starting doses, suggesting that physicians tailor treatment according to local guidelines or previous experience.

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