Schering-Plough recently announced the launch of a major study pitting their pegylated interferon, Peg-Intron, against Roche’s Pegasys. The study is dubbed IDEAL, an inventive acronym for “Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy.” IDEAL will enroll 2,880 adults with hepatitis C at about 100 sites across the United States (see IDEAL web site for study locations). To be eligible for the study, you have to have hepatitis C genotype 1 (the strain most common in the U.S., but least responsive to treatment). Only people who have never been treated before will be included (see inclusion and exclusion criteria).
The study requires that you be “free from substance abuse for the past 2 years” – a more conservative criteria than those recommended in the AASLD clinical practice guidelines [PDF] and the 2002 NIH consensus statement. The study also excludes people co-infected with HIV, who generally do not respond as well overall to hepatitis C treatment.
People enrolled in the study will be randomly assigned to one of three arms, each providing 48 weeks of treatment (study drugs provided for free):
Arm 1: high-dose Peg-Intron (1.5 μg/kg/week) with weight-based ribavirin (Schering’s Rebetol, at 800-1,400 mg/day) – 960 study participants
Arm 2: low-dose Peg-Intron (1.0 μg/kg/week) with weight-based ribavirin (Schering’s Rebetol, at 800-1,400 mg/day) – 960 study participants
Arm 3: Pegasys (180 μg/week) with weight-based ribavirin (Roche’s Copegus, at 1,000-1,200 mg/day) – 960 study participants
The study is designed to see whether there are differences between the three arms in the proportion of study participants achieving a sustained virologic response (SVR), defined as an undetectable hepatitis C viral load 6 months after the end of treatment.
So — assuming that you’re clean and sober and HIV-negative — should you rush off to sign up for this trial? First, it’s worth understanding the reasons for the three-arm design.