Year: 2002
Type: letter
Abstract: et al. achieved a 30% rate of sustained virologic remission (SVR) with combination antiviral therapy among patients with chronic hepatitis C who had not responded previously to interferon. 1 This is the highest rate reported for such a study, but one notes the drug discontinuation rate was only 5%.By comparison, discontinuation rates of 13% to 14% were observed in a recent large-scale trial of combination therapy, 2 and one suspects that the rate would be higher yet in practice.The investigators correctly pointed out that there was not a statistically significant difference in SVR rate between 24 and 48 weeks of treatment.However, the study did not have sufficient power to say whether the 9 percentage-point difference observed (36% vs. 27%) was real or not.To detect a difference of 35% vs. 25% with even 80% power would require 328 patients per group, not 62. 3 The methods section did not include an a priori power calculation or sample size estimate, so it is not clear why 124 patients were studied.This could have been a pilot study to see if a larger, randomized, controlled trial were warranted.However, one is also left with the possible conclusion that the investigators might have performed a randomized trial in which there was insufficient power to answer the question posed.
Source: Hepatology
Authors: Adrian M. Di Bisceglie, Bruce R. Bacon
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4231060196