Roche’s Pegylated Interferon, Combined With Ribavirin, Suppresses 61% of Hepatitis C Cases, Study SaysHoffmann-La Roche's experimental pegylated interferon, known as Pegasys, when coupled with the antiviral drug ribavirin suppressed hepatitis C in 61% of subjects, according to the findings of an international study reported yesterday at the 37th Annual Meeting of the European Association for the Study of the Liver in Madrid, the Washington Post reports. The suppression rate is "the highest figure ever reported in a comparable study," the Post adds (Gillis, Washington Post, 4/19). Researchers from 99 medical centers, including 29 U.S. sites, treated more than 12,000 hepatitis C patients with various doses of the pegylated interferon and ribavirin combination, providing weekly drug injections for either 24 weeks or 48 weeks (Talan, Newsday, 4/19). In addition to the overall 61% reduction, the study found the combination suppressed the virus in 51% of subjects with hepatitis C genotype 1, a strain that is "particularly difficult" to treat and is the most common in the United States. "Now, in the most difficult patients to successfully treat, we have a better-than-even chance of eliminating the virus. That's the first time we can say that," researcher Henry Bodenheimer, chief of the division of digestive diseases at Beth Israel Medical Center, said (Washington Post, 4/19). The findings also showed that optimum results could be attained by adapting the treatment regimen to the type of hepatitis C in the subject's bloodstream. "These data are very important because we know that for certain patients, we can use a lower dose of therapy and cut the treatment duration by half without sacrificing efficacy. Potentially, this can spare some patients nearly six months of unnecessary treatment," Dr. Donald Jensen, a leading investigator for the study and a liver specialist at Rush-Presbyterian-St. Luke's Medical Center in Chicago, said (Reuters, 4/18).
Roche, Schering Plough 'Marketing War'?
The study may start a "marketing war" between Roche and Schering-Plough, which manufactures PEG-Intron, a pegylated interferon with a different chemical formulation than Pegasys, the Post reports. PEG-Intron won FDA approval last year after studies indicated that the drug, when given in combination with ribavirin, suppressed hepatitis C in 52% of study subjects (Washington Post, 4/19). A European Union advisory committee recommended in March that Pegasys be approved for use on its own and in combination with ribavirin, Reuters reports. Pegasys still awaits U.S. clearance, although Roche official William Burns said earlier this week that the company "hoped to get a fast-track U.S. regulatory review of Pegasys when it submits data in June" (Reuters, 4/18). The Post notes that many liver doctors have "long speculated" that Pegasys would prove slightly more effective than PEG-Intron. But Schering-Plough spokesperson Robert Consalvo said yesterday that PEG-Intron and Pegasys have "not been compared head-to-head in studies," so "no firm conclusions can be drawn about their relative effectiveness" (Washington Post, 4/19).