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

Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Research Abstract Details 

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Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Abstract Text:

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

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 2007.).

Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Publishing Authors By Initials

A Mangia,N Minerva,D Bacca,R Cozzolongo,GL Ricci,V Carretta,F Vinelli,G Scotto,G Montalto,M Romano,G Cristofaro,L Mottola,F Spirito,A Andriulli,A Mangia,N Minerva,D Bacca,R Cozzolongo,GL Ricci,V Carretta,F Vinelli,G Scotto,G Montalto,M Romano,G Cristofaro,L Mottola,F Spirito,A Andriulli,

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Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Hepatology (Baltimore, Md.)

VOLUME: 47

Page Numbers: 43-50

Journal Abbreviation: Hepatology

ISSN: 1527-3350

DAY: 2

MONTH: Jan

YEAR: 2008

Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Information

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LANGUAGE: eng

NlmUniqueID: 8302946

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AFFILIATION: Gastroenterology, Istituto di Ricovero e Cura a Carattere Scientifico, "Casa Sollievo della Sofferenza" Hospital, San Giovanni Rotondo, Italy.

Country: United States

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MEDLINETA: Hepatology

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