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

✍ Scribed by 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

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 269 KB
• Volume: 47
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.22061

✦ Synopsis

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 >or=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.