Reduced Treatment Time Noninferior for Some With Hep C
Hepatitis C virologic response similar with peginterferon-ribavirin for 24 versus 48 weeks
WEDNESDAY, Sept. 14 (HealthDay News) -- Sustained virologic response for some patients who have chronic hepatitis C virus (HCV) was found to be noninferior when treating for 24 weeks versus 48 weeks, according to a study published in the Sept. 15 issue of the New England Journal of Medicine.
Kenneth E. Sherman, M.D., Ph.D., from the University of Cincinnati College of Medicine, and colleagues compared the sustained virologic response for patients with HCV receiving two treatment durations. Initially, 540 treatment-naive patients with HCV genotype 1 were given telaprevir, peginterferon alfa-2a, and ribavirin for 12 weeks. Of the 352 patients who achieved extended rapid virologic response, 322 were randomly assigned after week 20 to continued peginterferon-ribavirin for a total of 24 weeks of treatment (T12PR24) or continued peginterferon-ribavirin for a total of 48 weeks of treatment (T12PR48). Patients who had not achieved extended rapid virologic response at four and 12 weeks were assigned to the T12PR48 group.
The investigators found that the overall rate of sustained virologic response was 72 percent. Of the 322 patients assigned to the study groups who had extended rapid virologic response and a week 20 visit, 92 percent in the T12PR24 group and 88 percent in the T12PR48 group achieved sustained virologic response, thereby establishing noninferiority.
"Regimen of peginterferon-ribavirin for 24 weeks, with telaprevir for the first 12 weeks, was noninferior to the same regimen for 48 weeks in patients with undetectable HCV RNA at weeks four and 12," the authors write.
The study was funded by Vertex Pharmaceuticals and Tibotec; several authors disclosed financial relationships with these and other pharmaceutical companies.