In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions
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]
Search for more papers by this authorTivadar Bányai
Department of Infectology, Pándy Kálmán Hospital, Gyula, Hungary
Search for more papers by this authorGiuseppe De Bartolomeo
Internal Medicine Liver Unit Hospital, F. Veneziale, Isernia, Italy
Search for more papers by this authorJudit Gervain
Department of Internal Medicine/Hepatology and Molecular Diagnostic laboratories, Szent Gyorgy Hospital, Székesfehérvár, Hungary
Search for more papers by this authorFrançois Habersetzer
Pôle Hépato-digestif, Inserm 1110, Université de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France
Search for more papers by this authorJean-Pierre Mulkay
Hepato-gastroenterology, CHU Saint-Pierre, Brussels, Belgium
Search for more papers by this authorDenis Ouzan
Institut Arnault Tzanck, Saint-Laurent-du-Var, France
Search for more papers by this authorGiustino Parruti
Infectious Disease Unit, Santo Spirito General Hospital, Pescara, Italy
Search for more papers by this authorNicola Passariello
Department of Geriatrics and Metabolic Diseases, University of Naples, Naples, Italy
Search for more papers by this authorAndre-Jean Remy
Centre Hospitalier de Perpignan, Perpignan, France
Search for more papers by this authorMitchell L. Shiffman
Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport News, VA, USA
Search for more papers by this authorAlan D. Tice
Infections Limited Hawaii, Honolulu, HI, USA
In memoriam.Search for more papers by this authorMaribel Rodriguez-Torres
Fundación de Investigación, San Juan, PR, USA
Search for more papers by this authorCorresponding 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]
Search for more papers by this authorTivadar Bányai
Department of Infectology, Pándy Kálmán Hospital, Gyula, Hungary
Search for more papers by this authorGiuseppe De Bartolomeo
Internal Medicine Liver Unit Hospital, F. Veneziale, Isernia, Italy
Search for more papers by this authorJudit Gervain
Department of Internal Medicine/Hepatology and Molecular Diagnostic laboratories, Szent Gyorgy Hospital, Székesfehérvár, Hungary
Search for more papers by this authorFrançois Habersetzer
Pôle Hépato-digestif, Inserm 1110, Université de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France
Search for more papers by this authorJean-Pierre Mulkay
Hepato-gastroenterology, CHU Saint-Pierre, Brussels, Belgium
Search for more papers by this authorDenis Ouzan
Institut Arnault Tzanck, Saint-Laurent-du-Var, France
Search for more papers by this authorGiustino Parruti
Infectious Disease Unit, Santo Spirito General Hospital, Pescara, Italy
Search for more papers by this authorNicola Passariello
Department of Geriatrics and Metabolic Diseases, University of Naples, Naples, Italy
Search for more papers by this authorAndre-Jean Remy
Centre Hospitalier de Perpignan, Perpignan, France
Search for more papers by this authorMitchell L. Shiffman
Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport News, VA, USA
Search for more papers by this authorAlan D. Tice
Infections Limited Hawaii, Honolulu, HI, USA
In memoriam.Search for more papers by this authorMaribel Rodriguez-Torres
Fundación de Investigación, San Juan, PR, USA
Search for more papers by this authorAbstract
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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