Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial

Giuseppe Montalto, Vito Carretta, Nicola Minerva, Donato Bacca, Raffaele Cozzolongo, Giuseppe Cristofaro, Gaetano Scotto, Fulvio Spirito, Angelo Andriulli, Alessandra Mangia, Mario Romano, Francesco Vinelli, Leonardo Mottola, Giovanni L. Ricci

Risultato della ricerca: Article

231 Citazioni (Scopus)

Abstract

It was hypothesized that in hepatitis C virus (HCV) genotype 1 patients, variable treatment duration individualized by first undetectable HCV RNA is as effective as standard 48-week treatment. Patients (n_696) received peginterferon alfa-2a, 180 mg/week, or peginterferon alfa-2b, 1.5 mg/kg/week, plus ribavirin, 1000-1200 mg/day, for 48 weeks (standard, n _237) or for 24, 48, or 72 weeks if HCV-RNA–negative at weeks 4, 8, or 12, respectively (variable, n _ 459). Sustained virologic response (SVR) was achieved in 45.1% [95% confidence interval (CI) 38.8-51.4] of the patients in the standard group and in 48.8% (CI 44.2-53.3) of the patients in the variable group (P _ 0.37). The percentages of patients who first achieved undetectable HCV RNA at weeks 4, 8, or 12 were 26.7%, 27.8%, and 11.3%, respectively. In the standard treatment group, 87.1%, 70.3%, and 38.1% of patients who first achieved undetectable HCV RNA at 4, 8, or 12 weeks attained SVRs, respectively. In the variable group, corresponding SVR rates were 77.2%, 71.9%, and 63.5%. Low viremia levels and young age were independent predictors of response at week 4 [rapid virologic response (RVR)]. RVR patients with baseline viremia >400,000 IU/mL achieved higher SVR rates when treated for 48 weeks rather than 24 weeks (86.8% versus 73.1%, P _ 0.14). The only predictive factor of SVR in RVR patients was advanced fibrosis. Conclusion: Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs. (HEPATOLOGY 2008;47:43-50.)
Lingua originaleEnglish
pagine (da-a)43-50
RivistaHepatology
Volume47
Stato di pubblicazionePublished - 2008

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Hepatitis C
Randomized Controlled Trials
Genotype
Hepacivirus
RNA
Viremia
Therapeutics
Confidence Intervals
Ribavirin
Fibrosis
Sustained Virologic Response
Costs and Cost Analysis

All Science Journal Classification (ASJC) codes

  • Hepatology

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Montalto, G., Carretta, V., Minerva, N., Bacca, D., Cozzolongo, R., Cristofaro, G., ... Ricci, G. L. (2008). Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial. Hepatology, 47, 43-50.

Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial. / Montalto, Giuseppe; Carretta, Vito; Minerva, Nicola; Bacca, Donato; Cozzolongo, Raffaele; Cristofaro, Giuseppe; Scotto, Gaetano; Spirito, Fulvio; Andriulli, Angelo; Mangia, Alessandra; Romano, Mario; Vinelli, Francesco; Mottola, Leonardo; Ricci, Giovanni L.

In: Hepatology, Vol. 47, 2008, pag. 43-50.

Risultato della ricerca: Article

Montalto, G, Carretta, V, Minerva, N, Bacca, D, Cozzolongo, R, Cristofaro, G, Scotto, G, Spirito, F, Andriulli, A, Mangia, A, Romano, M, Vinelli, F, Mottola, L & Ricci, GL 2008, 'Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial', Hepatology, vol. 47, pagg. 43-50.
Montalto G, Carretta V, Minerva N, Bacca D, Cozzolongo R, Cristofaro G e altri. Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial. Hepatology. 2008;47:43-50.
Montalto, Giuseppe ; Carretta, Vito ; Minerva, Nicola ; Bacca, Donato ; Cozzolongo, Raffaele ; Cristofaro, Giuseppe ; Scotto, Gaetano ; Spirito, Fulvio ; Andriulli, Angelo ; Mangia, Alessandra ; Romano, Mario ; Vinelli, Francesco ; Mottola, Leonardo ; Ricci, Giovanni L. / Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial. In: Hepatology. 2008 ; Vol. 47. pagg. 43-50.
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abstract = "It was hypothesized that in hepatitis C virus (HCV) genotype 1 patients, variable treatment duration individualized by first undetectable HCV RNA is as effective as standard 48-week treatment. Patients (n_696) received peginterferon alfa-2a, 180 mg/week, or peginterferon alfa-2b, 1.5 mg/kg/week, plus ribavirin, 1000-1200 mg/day, for 48 weeks (standard, n _237) or for 24, 48, or 72 weeks if HCV-RNA–negative at weeks 4, 8, or 12, respectively (variable, n _ 459). Sustained virologic response (SVR) was achieved in 45.1{\%} [95{\%} confidence interval (CI) 38.8-51.4] of the patients in the standard group and in 48.8{\%} (CI 44.2-53.3) of the patients in the variable group (P _ 0.37). The percentages of patients who first achieved undetectable HCV RNA at weeks 4, 8, or 12 were 26.7{\%}, 27.8{\%}, and 11.3{\%}, respectively. In the standard treatment group, 87.1{\%}, 70.3{\%}, and 38.1{\%} of patients who first achieved undetectable HCV RNA at 4, 8, or 12 weeks attained SVRs, respectively. In the variable group, corresponding SVR rates were 77.2{\%}, 71.9{\%}, and 63.5{\%}. Low viremia levels and young age were independent predictors of response at week 4 [rapid virologic response (RVR)]. RVR patients with baseline viremia >400,000 IU/mL achieved higher SVR rates when treated for 48 weeks rather than 24 weeks (86.8{\%} versus 73.1{\%}, P _ 0.14). The only predictive factor of SVR in RVR patients was advanced fibrosis. Conclusion: Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs. (HEPATOLOGY 2008;47:43-50.)",
author = "Giuseppe Montalto and Vito Carretta and Nicola Minerva and Donato Bacca and Raffaele Cozzolongo and Giuseppe Cristofaro and Gaetano Scotto and Fulvio Spirito and Angelo Andriulli and Alessandra Mangia and Mario Romano and Francesco Vinelli and Leonardo Mottola and Ricci, {Giovanni L.}",
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T1 - Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial

AU - Montalto, Giuseppe

AU - Carretta, Vito

AU - Minerva, Nicola

AU - Bacca, Donato

AU - Cozzolongo, Raffaele

AU - Cristofaro, Giuseppe

AU - Scotto, Gaetano

AU - Spirito, Fulvio

AU - Andriulli, Angelo

AU - Mangia, Alessandra

AU - Romano, Mario

AU - Vinelli, Francesco

AU - Mottola, Leonardo

AU - Ricci, Giovanni L.

PY - 2008

Y1 - 2008

N2 - It was hypothesized that in hepatitis C virus (HCV) genotype 1 patients, variable treatment duration individualized by first undetectable HCV RNA is as effective as standard 48-week treatment. Patients (n_696) received peginterferon alfa-2a, 180 mg/week, or peginterferon alfa-2b, 1.5 mg/kg/week, plus ribavirin, 1000-1200 mg/day, for 48 weeks (standard, n _237) or for 24, 48, or 72 weeks if HCV-RNA–negative at weeks 4, 8, or 12, respectively (variable, n _ 459). Sustained virologic response (SVR) was achieved in 45.1% [95% confidence interval (CI) 38.8-51.4] of the patients in the standard group and in 48.8% (CI 44.2-53.3) of the patients in the variable group (P _ 0.37). The percentages of patients who first achieved undetectable HCV RNA at weeks 4, 8, or 12 were 26.7%, 27.8%, and 11.3%, respectively. In the standard treatment group, 87.1%, 70.3%, and 38.1% of patients who first achieved undetectable HCV RNA at 4, 8, or 12 weeks attained SVRs, respectively. In the variable group, corresponding SVR rates were 77.2%, 71.9%, and 63.5%. Low viremia levels and young age were independent predictors of response at week 4 [rapid virologic response (RVR)]. RVR patients with baseline viremia >400,000 IU/mL achieved higher SVR rates when treated for 48 weeks rather than 24 weeks (86.8% versus 73.1%, P _ 0.14). The only predictive factor of SVR in RVR patients was advanced fibrosis. Conclusion: Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs. (HEPATOLOGY 2008;47:43-50.)

AB - It was hypothesized that in hepatitis C virus (HCV) genotype 1 patients, variable treatment duration individualized by first undetectable HCV RNA is as effective as standard 48-week treatment. Patients (n_696) received peginterferon alfa-2a, 180 mg/week, or peginterferon alfa-2b, 1.5 mg/kg/week, plus ribavirin, 1000-1200 mg/day, for 48 weeks (standard, n _237) or for 24, 48, or 72 weeks if HCV-RNA–negative at weeks 4, 8, or 12, respectively (variable, n _ 459). Sustained virologic response (SVR) was achieved in 45.1% [95% confidence interval (CI) 38.8-51.4] of the patients in the standard group and in 48.8% (CI 44.2-53.3) of the patients in the variable group (P _ 0.37). The percentages of patients who first achieved undetectable HCV RNA at weeks 4, 8, or 12 were 26.7%, 27.8%, and 11.3%, respectively. In the standard treatment group, 87.1%, 70.3%, and 38.1% of patients who first achieved undetectable HCV RNA at 4, 8, or 12 weeks attained SVRs, respectively. In the variable group, corresponding SVR rates were 77.2%, 71.9%, and 63.5%. Low viremia levels and young age were independent predictors of response at week 4 [rapid virologic response (RVR)]. RVR patients with baseline viremia >400,000 IU/mL achieved higher SVR rates when treated for 48 weeks rather than 24 weeks (86.8% versus 73.1%, P _ 0.14). The only predictive factor of SVR in RVR patients was advanced fibrosis. Conclusion: Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs. (HEPATOLOGY 2008;47:43-50.)

UR - http://hdl.handle.net/10447/1504

M3 - Article

VL - 47

SP - 43

EP - 50

JO - Hepatology

JF - Hepatology

SN - 0270-9139

ER -