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

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

Research output: Contribution to journalArticlepeer-review

231 Citations (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 rateswhen 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.)
Original languageEnglish
Pages (from-to)43-50
JournalHEPATOLOGY
Volume47
Publication statusPublished - 2008

All Science Journal Classification (ASJC) codes

  • Hepatology

Fingerprint Dive into the research topics of 'Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial'. Together they form a unique fingerprint.

Cite this