Hepatitis C Treatment Study Being Questioned
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To me, the study referenced in the article below is unnecessary. There appears to be negligible difference between the two main treatments for Hepatitis C. While Roche has been shown to have an advantage regarding side effects and effectiveness, this difference seems to be somewhat insignificant (although, if I were to choose to intiate therapy at this time, I would choose the Roche product, Pegasys).
A lot of time, money and effort is being spent on this study when other (more effective and less toxic) treatments could be being developed, instead. It seems like comparing two brands of aspirin. In the long run, there is so little difference that it just comes down to what the marketing people choose to advertise and how.
Also, I am suspect of any study funded by an entity that has a vested interest in the final result. Call me suspicious, call me skeptical, but conflict of interest is a known problem wherever it exists. If the study shows the Roche product is better can we really expect Schering not to put some kind of spin on it to do major damage control? We are talking about a billion dollar annual business (Hepatitis C treatment). What do you think?
Schering-Plough Defends Design of “IDEAL” Study Comparing Peg-Intron with Pegasys
By Ronald Baker, PhD, HIVandHepatitis.com
Supported by Schering-Plough (Schering), manufacturer of Peg-Intron (pegylated interferon alfa-2b), the IDEAL trial will compare the efficacy of Peg-Intron versus Roche Pharmaceuticals’ Pegasys (pegylated interferon alfa-2a), both in combination with ribavirin.
A recent Reuters News wire story raised the issue that the IDEAL study protocol calls for ribavirin starting doses and ribavirin dose reduction rates that are not equivalent in two arms of the study (Peg-Intron/ribavirin versus Pegasys/ribavirin combination therapy).
The Reuters reporter quoted John McHutchison, MD, one of the principal investigators of the trial, as saying that the study’s design will probably allow more patients receiving Peg-Intron to stay on higher doses of ribavirin than those taking Pegasys, and further, “The dose reductions for ribavirin are not equivalent in the two arms of the study and could therefore introduce a potential ‘bias’ in favor of the Peg-Intron arm of the trial.”
The decision on the size of the ribavirin dose reductions in the Pegasys arm appears to have been made by the FDA, not Schering. The FDA insisted that instructions on the Pegasys drug label be followed—any ribavirin reductions must be to 600 milligrams, according to the Reuters story. “The FDA wouldn’t allow it (smaller ribavirin dose cutbacks), and unfortunately that’s the way it stands,” McHutchison said.
The IDEAL study is a large trial that when fully enrolled, will involve nearly 3,000 patients at approximately 100 medical sites in the US. The results of the trial, not expected until 2007, could influence the choice of peginterferon treatment (Pegasys or Peg-Intron) selected by chronic hepatitis C patients and their doctors. For this reason alone, both Roche and Schering have a big stake in the final study results. Of course, it’s possible that the safety and efficacy differences between the two drugs may turn out not to be statistically significant.
Schering feels that the Reuters news story neglected to point out that the IDEAL trial focuses on the different treatment approaches inherent in the two combination regimens being evaluated (Pegasys/ribavirin versus Peg-Intron/ribavirin) and further that “the study is powered to show differences between the Peg-Intron and Pegasys regimens.”
“Unfortunately,” says Schering Communications Director Robert Consalvo, “the Reuters story neglected this point and instead focused on the potential for bias caused by the different ribavirin doses.”
Following is the text of a statement by Schering on the IDEAL study that the company says is intended to clarify possible confusion about the trial generated by the Reuters article. Following is the text of the statement from Schering, released on January 21, 2005.
Schering-Plough Statement on the “IDEAL” Study
The IDEAL study is a three-arm clinical trial involving nearly 3,000 U.S. patients with chronic hepatitis C genotype 1, the most difficult form of the virus to treat and most common worldwide. The study is designed to address two separate issues: 1) a comparison of two doses of PEG-INTRON (1.0 vs. 1.5 mcg/kg weekly) used in combination with ribavirin, and 2) a head-to-head comparison of treatment regimens with PEG-INTRON versus PEGASYS, both used in combination with ribavirin.
The IDEAL study compares the efficacy and safety of these different treatment regimens in the same patient population.
The PEG-INTRON and REBETOL (ribavirin) regimens use an individualized approach to therapy in which both products are dosed according to patient body weight: PEG-INTRON (1.0 and 1.5 mcg/kg weekly) and REBETOL (800-1,400 mg/day). PEGASYS and COPEGUS (ribavirin) are dosed in accordance with the FDA-approved labeling: the same dose of PEGASYS (180 mcg weekly) to all patients regardless of individual body weight, and COPEGUS dosed either at 1,000 mg or 1,200 mg daily.
Based on these different treatment approaches (weight-based dosing vs. flat dosing), interferon and ribavirin dosing will differ for many patients. All patients in the PEGASYS arm will receive more interferon for their starting dose than patients in the PEG-INTRON arms. Ribavirin dosing is different for some patients in the study, but the ribavirin dosing is not expected to favor any one dosing regimen overall. Additional analyses will examine the effect of these different treatment approaches.
The results of the IDEAL study will provide physicians and their patients with important information that will help them make informed treatment decisions.
Status of Study
The IDEAL study (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) will involve up to 100 U.S. sites. Enrollment for the study is on schedule. At the end of 2004, more than 90 centers in the study had screened approximately 1,500 patients and enrolled more than 700 patients. Final study results are expected in 1H 2007.
Full-study results will be reviewed by a panel of international experts in liver disease and presented at appropriate medical meetings.
01/24/05
Sources
R Consalvo. Statement from Schering-Plough on the IDEAL Study. January 21, 2004.
R Pierson. Researcher Cites “Bias” Toward Peg-Intron in Trial. Reuters News. January 7, 2004.
