Game Changers in Gastroenterology: 2011

David A. Johnson, MD


November 23, 2011

In This Article

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 1 125/311 40% ------ 12/52 23% -------
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.


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