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Boceprevir induced higher response rates in HCV genotype 1

Issue: April 2011

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Data from two studies published in The New England Journal of Medicine indicate that the addition of boceprevir to peginterferon-ribavirin treatment resulted in significantly higher rates of sustained virologic response in patients previously treated and patients with previously untreated hepatitis C virus genotype 1.

RESPOND-2 trial

In the hepatitis C virus (HCV) RESPOND-2 trial, 403 patients with previously treated chronic HCV genotype 1 infection were randomly assigned in a 1:2:2 ratio to one of three groups. In all three groups, the patients received 4 weeks of peginterferon alfa-2b and ribavirin during the lead-in period. Group one received placebo plus peginterferon-ribavirin for 44 weeks. Group two received boceprevir (Victrelis, Merck) plus peginterferon-ribavirin for 32 weeks, and patients received 12 more weeks of peginterferon-ribavirin if they had a detectable HCV RNA level at week 8. Group three received boceprevir plus peginterferon-ribavirin for 44 weeks.

The rate of sustained virologic response was 59% in group two and 66% in group three, which was significantly higher than the rate of 21% in group one, the control group. The rate of sustained virologic response among patients with an undetectable HCV RNA level at week 8 was 86% after 32 weeks of triple therapy and 88% after 44 weeks of triple therapy. More patients in the boceprevir group experienced anemia compared with the control group.

SPRINT-2 trial

The SPRINT-2 trial included 938 nonblack patients and 159 black patients with untreated HCV genotype 1. They were randomly assigned to one of three groups. In all three groups, the patients received 4 weeks of peginterferon alfa-2b and ribavirin during the lead-in period. Group one received peginterferon-ribavirin for 44 weeks. Group two received boceprevir plus peginterferon-ribavirin for 24 weeks, and patients received peginterferon-ribavirin for an additional 20 weeks if they had a detectable HCV RNA level between weeks 8 and 24. Group three received boceprevir plus peginterferon-ribavirin for 44 weeks.

In the cohort of nonblack patients, 67% of patients in group two and 68% of patients in group three achieved a sustained virologic response vs. 40% of patients in group one, the control group. In the black cohort, 42% of patients in group two and 53% of patients in group three achieved a sustained virologic response vs. 23% of patients in group one. Anemia led to dose reductions in 13% of controls and 21% of those who received boceprevir.

Both trials were supported by Merck.

For more information:

• Bacon BR. N Engl J Med. 2011;364:1207-1217.

• Poordad F. N Engl J Med. 2011;364:1195-1206.

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