Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection

By B. Bacon, S. Gordon, E. Lawitz, P. Marcellin, J. Vierling, S. Zeuzem, F. Poordad, Z. Goodman, H. Sings, N. Boparai and 4 more. New England Journal of Medicine, 2011

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BACKGROUND In patients with chronic infection with hepatitis C virus (HCV) genotype 1 who do not have a sustained response to therapy with peginterferon–ribavirin, outcomes after retreatment are suboptimal. Boceprevir, a protease inhibitor that binds to the HCV nonstructural 3 (NS3) active site, has been suggested as an additional treatment. METHODS To assess the effect of the combination of boceprevir and peginterferon–ribavirin for retreatment of patients with chronic HCV genotype 1 infection, we randomly assigned patients (in a 1:2:2 ratio) to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the lead-in period). Subsequently, group 1 (control group) received placebo plus peginterferon–ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon–ribavirin for 32 weeks, and patients with a detectable HCV RNA level at week 8 received placebo plus peginterferon–ribavirin for an additional 12 weeks; and group 3 received boceprevir plus peginterferon–ribavirin for 44 weeks. RESULTS A total of 403 patients were treated. The rate of sustained virologic response was significantly higher in the two boceprevir groups (group 2, 59%; group 3, 66%) than in the control group (21%, P<0.001). Among patients with an undetectable HCV RNA level at week 8, the rate of sustained virologic response was 86% after 32 weeks of triple therapy and 88% after 44 weeks of triple therapy. Among the 102 patients with a decrease in the HCV RNA level of less than 1 log10 IU per milliliter at treatment week 4, the rates of sustained virologic response were 0%, 33%, and 34% in groups 1, 2, and 3, respectively. Anemia was significantly more common in the boceprevir groups than in the control group, and erythropoietin was administered in 41 to 46% of boceprevir-treated patients and 21% of controls. CONCLUSIONS The addition of boceprevir to peginterferon–ribavirin resulted in significantly higher rates of sustained virologic response in previously treated patients with chronic HCV genotype 1 infection, as compared with peginterferon–ribavirin alone.

Subfields: Emergency Medicine, Hepatology, Infectious Diseases

View Paper: https://www.semanticscholar.org/paper/b2de447f6b19919a5331a787315de3a7886da480

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Citations in the corpus

• EASL Recommendations on Treatment of Hepatitis C 2018. (2018, background): “In the phase III trials of boceprevir and telaprevir in HCV genotype 1 treatment-naïve patients, triple therapy regimens achieved higher SVR rates than pegylated IFN-α/ribavirin dual therapy, of the order of 65% to 75% [4-7].”
• EASL Recommendations on Treatment of Hepatitis C 2015. (2015, background): “In the Phase III trials of boceprevir and telaprevir in HCV genotype 1 treatment-naïve patients, triple therapy regimens achieved higher SVR rates than PegIFN-a and ribavirin dual therapy, of the order of 65% to 75% [7] [8] [9] [10].”
• EASL Recommendations on Treatment of Hepatitis C 2016. (2017, background): “In the phase III trials of boceprevir and telaprevir in HCV genotype 1 treatment-naïve patients, triple therapy regimens achieved higher SVR rates than pegylated IFN-α/ribavirin dual therapy, of the order of 65% to 75% [4-7].”