Reuters Health Information (2008-01-15): Individualized treatment duration for HCV meets with success
Individualized treatment duration for HCV meets with success
Last Updated: 2008-01-15 14:10:18 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In patients with hepatitis C virus (HCV), individualizing the duration of peginterferon/ribavirin treatment yields success rates similar to standard 48-week treatment, thus sparing unnecessary costs and side effects, according to results of two randomized controlled studies published in the January issue of Hepatology.
In one study, Dr. Alessandra Mangia from "Casa Sollievo della Sofferenza" Hospital, San Giovanni Rotondo, Italy, and colleagues treated 696 patients with HCV genotype 1 with peginterferon alfa-2a (180 �g/week) or peginterferon alfa-2b (1.5 �g/kg/week), plus ribavirin (1,000 to 1,200 mg/day). Patients were randomized to treatment for 48 weeks (the standard treatment group; n = 237) or for 24, 48 or 72 weeks if HCV-RNA was undetectable at 4, 8, or 12 weeks, respectively (the variable treatment group; n = 459).
According to the investigators, results showed "equivalent rates of lasting viral clearance after therapy administered for the standard 48-week length or a variable duration tailored on the first undetectable HCV RNA during the initial 12 weeks of therapy."
Nearly 49% of patients receiving variable treatment based on detectable HCV RNA achieved a sustained virologic response, compared with 45% of patients in the standard treatment group (p = 0.37), Dr. Mangia and colleagues report.
"This study shows that in HCV genotype 1, treatment duration should be tailored to the 12-week on-treatment virologic response," Dr. Mangia and colleagues write. "HCV RNA should be monitored qualitatively at week 4 to identify patients with the highest likelihood of response, and at weeks 8 and 12 to determine if extended duration may be required," they conclude.
Meanwhile, in a study of 428 patients with HCV genotype 2 or 3, researchers from Norway randomly assigned patients who achieved a virologic response after 4 weeks peginterferon alfa-2b (1.5 �g/kg) weekly and ribavirin (800 to 1,400 mg/day) to complete either 14 weeks or 24 weeks of treatment.
In intention-to-treat analysis, Dr. Olav Dalgard from Ulleval University Hospital, Oslo and colleagues found that 81.1% of patients in the 14-week treatment arm and 90.7% in the 24-week arm achieved a sustained viral response.
Among patients with an HCV RNA test 24 weeks after the end of treatment, 86.3% of the 14-week treatment group and 93.2% of the 24-week treatment group had a sustained viral response.
"In conclusion, we cannot formally claim that 14 weeks treatment is non-inferior to 24 weeks treatment," Dr. Dalgard and colleagues write. "However, the sustained virologic response rate after 14 weeks treatment is high, and although longer treatment may give a slightly better sustained viral response rate, we believe considerable economical savings, good response to re-treatment, and less side effects make it rational to treat patients with genotype 2 or 3 and rapid viral response for only 14 weeks."