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In the last issue (January 18, 2008), HIV and Hepatitis.com reported preliminary data from the IDEAL trial, comparing the 2 brands of pegylated interferon -- peginterferon alfa-2a (Pegasys) and peginterferon alfa-2b (PegIntron) - in combination with ribavirin for patients with genotype 1 chronic hepatitis C. That report included a press release from PegIntron manufacturer Schering-Plough, which sponsored the trial, and a response from Pegasys manufacturer Roche. In brief, the data suggested that while the end-of-treatment response rate was higher in the Pegasys group, fewer people taking PegIntron relapsed after completing therapy, so the sustained response rates for the 2 drugs were similar. However, the arms of the study were not fully comparable; in particular, participants taking PegIntron received a wider range of weight-based doses of ribavirin, which is known to reduce the risk of relapse. In the current (January-March 2008) issue of Liver Health Today, hepatology expert Douglas Dieterich, Chief Medical Officer at Mount Sinai Medical Center in New York City and Clinical Associate Professor of Medicine at New York University School of Medicine, offers a commentary on the interim IDEAL findings. After reviewing the principles of sound scientific evidence and good clinical trial design, Dieterich wrote, "All studies are not created equal, and the way a trial is designed or the question it is designed to answer can have a major impact on how useful the results will be in everyday life." With regard to IDEAL, Dieterich said that the comparison between the 2 study arms that used different doses of PegIntron is useful, since it should help define the correct dose, as required by the U.S. Food and Drug Administration (FDA). But he criticized the third study arm, which used Pegasys plus ribavirin, saying that the characterization of the study as a head-to-head trial is a "misnomer." "IDEAL
can't determine which drug is better because patients in the Pegasys…arm
receive a different ribavirin regimen than those in the PegIntron arm," he
wrote. "Not only do they receive a different starting dose of ribavirin,
but the way ribavirin doses are reduced in the event a patient has side effects
is also different." "Since ribavirin has [been] shown to have a clear impact on treatment success for both interferons, the trial can't tell us anything about the differences between the 2 interferons," Dieterich wrote. In addition, he noted that the study was not blinded - considered a hallmark of good trial design -- since both physicians and patients knew which type of peginterferon they were receiving. "While
[patients] rarely have the tools or medical knowledge to evaluate research on
their own, new studies provide the perfect opportunity to discuss treatment with
a doctor," Dieterich concluded. "Physicians ultimately recommend a particular
course of therapy not just on the findings of a particular study; they combine
all sound scientific evidence with their own expertise and knowledge to provide
each patient with an optimal treatment outcome." "Schering-Plough
believes IDEAL is a very important study and will help map how on-treatment responses
at specific milestones, baseline patient demographics (viral load, weight, etc.),
and predictability of response correlate to treatment outcome," Consalvo
wrote. "The study also will help clarify how fast onset of action correlates
to relapse rates and sustained response. These results will help guide physicians'
understanding of which patients are most likely to respond better to which treatment." Source
Hepatitis
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