Addition of boceprevir to standard therapy with peginterferon-ribavirin, as compared with standard therapy alone, significantly increases the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection according to a study published in New Engl Journal of Medicine 2011 Mar 31;364(13):1195-206
Poodhar F, M.D. from Cedars–Sinai Medical Center, Los Angeles, US evaluated Boceprevir, a potent oral HCV-protease inhibitor, as an additional treatment in phase 1 and phase 2 studies. In a double-blind study previously untreated adults with HCV genotype 1 infection were randomly assigned 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 (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. Nonblack patients and black patients were enrolled and analyzed separately.
The investigators found that a total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 40% in group 1; 67% in group 2 (P<0.001), and 68% in group 3 (P<0.001). In the black cohort, a sustained virologic response was achieved in 23% in group 1, in 42% in group 2 (P=0.04), and in 53% in group 3 (P=0.004). In group 2, a total of 44% of patients received peginterferon-ribavirin for 28 weeks. Anemia led to dose reductions in 13% of controls and 21% of boceprevir recipients, with discontinuations in 1% and 2%, respectively.
The authors concluded that the addition of boceprevir to standard therapy with peginterferon-ribavirin, as compared with standard therapy alone, significantly increased the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection. The rates were similar with 24 weeks and 44 weeks of boceprevir.
http://www.ncbi.nlm.nih.gov/pubmed/21449783?dopt=Abstract
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