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

Alessandra Mangia, Tivadar Bányai, Giuseppe De Bartolomeo, Judit Gervain, François Habersetzer, Jean Pierre Mulkay, Denis Ouzan, Giustino Parruti, Nicola Passariello, Andre Jean Remy, Mario Rizzetto, Mitchell L. Shiffman, Alan D. Tice, Manuela Schmitz, Fernando Tatsch, Maribel Rodriguez-Torres

Research output: Contribution to journalArticle

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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.

Original languageEnglish
JournalLiver International
Volume34
Issue number7
DOIs
Publication statusPublished - 2014

Fingerprint

Hepacivirus
Physicians
Ribavirin
RNA
Therapeutics
Guidelines
Chronic Hepatitis C
Virus Diseases
Cohort Studies
Genotype
Prospective Studies
Injections
Infection
Pharmaceutical Preparations

Keywords

  • Abbreviated therapy
  • Clinical practice
  • Hepatitis C
  • Peginterferon alfa/ribavirin
  • Physician behaviour
  • PROPHESYS
  • Ribavirin dose
  • Treatment decisions
  • Viral kinetics

ASJC Scopus subject areas

  • Hepatology
  • Medicine(all)

Cite this

Mangia, A., Bányai, T., De Bartolomeo, G., Gervain, J., Habersetzer, F., Mulkay, J. P., ... Rodriguez-Torres, M. (2014). In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions. Liver International, 34(7). https://doi.org/10.1111/liv.12352

In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions. / Mangia, Alessandra; Bányai, Tivadar; De Bartolomeo, Giuseppe; Gervain, Judit; Habersetzer, François; Mulkay, Jean Pierre; Ouzan, Denis; Parruti, Giustino; Passariello, Nicola; Remy, Andre Jean; Rizzetto, Mario; Shiffman, Mitchell L.; Tice, Alan D.; Schmitz, Manuela; Tatsch, Fernando; Rodriguez-Torres, Maribel.

In: Liver International, Vol. 34, No. 7, 2014.

Research output: Contribution to journalArticle

Mangia, A, Bányai, T, De Bartolomeo, G, Gervain, J, Habersetzer, F, Mulkay, JP, Ouzan, D, Parruti, G, Passariello, N, Remy, AJ, Rizzetto, M, Shiffman, ML, Tice, AD, Schmitz, M, Tatsch, F & Rodriguez-Torres, M 2014, 'In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions', Liver International, vol. 34, no. 7. https://doi.org/10.1111/liv.12352
Mangia, Alessandra ; Bányai, Tivadar ; De Bartolomeo, Giuseppe ; Gervain, Judit ; Habersetzer, François ; Mulkay, Jean Pierre ; Ouzan, Denis ; Parruti, Giustino ; Passariello, Nicola ; Remy, Andre Jean ; Rizzetto, Mario ; Shiffman, Mitchell L. ; Tice, Alan D. ; Schmitz, Manuela ; Tatsch, Fernando ; Rodriguez-Torres, Maribel. / In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions. In: Liver International. 2014 ; Vol. 34, No. 7.
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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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AU - Mangia, Alessandra

AU - Bányai, Tivadar

AU - De Bartolomeo, Giuseppe

AU - Gervain, Judit

AU - Habersetzer, François

AU - Mulkay, Jean Pierre

AU - Ouzan, Denis

AU - Parruti, Giustino

AU - Passariello, Nicola

AU - Remy, Andre Jean

AU - Rizzetto, Mario

AU - Shiffman, Mitchell L.

AU - Tice, Alan D.

AU - Schmitz, Manuela

AU - Tatsch, Fernando

AU - Rodriguez-Torres, Maribel

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N2 - 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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KW - PROPHESYS

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KW - Treatment decisions

KW - Viral kinetics

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