Boceprevir for Untreated Chronic HCV Genotype 1 Infection
Poordad F, McCone J Jr, Bacon BR, et al.
N Engl J Med. 2011;364:1195-1206.
The addition of boceprevir (a protease inhibitor) to standard therapy with peginterferon-ribavirin, compared with standard therapy alone, significantly increased the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection. Patients were randomly assigned to one of 3 groups. In all 3 groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the lead-in period). Subsequently:
Group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks;
Group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and
Group 3 received boceprevir plus peginterferon-ribavirin for 44 weeks.
Black and nonblack patients were analyzed separately. Rates of sustained virologic response for these cohorts are shown in the Table. Rates were similar with 24 weeks and 44 weeks of boceprevir.
Table. Sustained Virologic Response, Nonblack vs Black Patients
|Nonblack Cohort||Black Cohort|
|# patients||%||P value||# patients||%||P value|
|Group 2||211/316||67%||< .001||22/52||42%||.04|
|Group 3||213/311||68%||< .001||29/55||53%||.004|
Why Is This a Game Changer?
Several concepts for the use of boceprevir in hepatitis C are important to clinical practice. Because it is a competitive inhibitor of the protease complex of HCV genotype 1, this drug does not have clinically significant activity against other HCV genotypes. Second, HCV has been shown to rapidly develop resistance when exposed to protease-inhibitor monotherapy, but the addition of interferon reduces the rate of emergence of these resistant variants. Clearly the protease inhibitors are "game changers" for defining a new standard for treatment of hepatitis C infection.
Medscape Gastroenterology © 2011
Cite this: David A. Johnson. Game Changers in Gastroenterology: 2011 - Medscape - Nov 23, 2011.