FDA Approves Improved Form of Interferon for Treatment of Hepatitis C
The FDA yesterday approved Hoffmann-La Roche's new hepatitis C drug Pegasys, an improved form of interferon, the Washington Post reports (Gillis, Washington Post, 10/17). The combination regimen of interferon-alpha and ribavirin has been the traditional hepatitis C treatment for several years, but interferon-alpha must be injected three times per week. Pegasys, a long-lasting form of interferon, must be injected only once a week (Fuhrmans, Wall Street Journal, 10/17). Recent studies have shown that a combination regimen of ribavirin and Pegasys is more effective at lowering hepatitis C viral levels than treatment with ribavirin and interferon-alpha (Kaiser Daily HIV/AIDS Report, 9/26). In addition, Pegasys allows doctors to determine after 12 weeks of treatment whether the drug will be effective in the patient, allowing patients experiencing treatment failure to cease treatment and avoid potential side effects (Wall Street Journal, 10/17). Although Pegasys was initially approved for use by itself to treat hepatitis C, most doctors will likely use it in conjunction with ribavirin, and formal FDA approval for the combination regimen is expected soon (Washington Post, 10/17). Roche is seeking FDA approval for its brand of ribavirin, Copegus, and hopes to launch a combination regimen of Copegus and Pegasys in the United States next year (Kaiser Daily HIV/AIDS Report, 7/16). Schering-Plough also manufactures a brand of pegylated interferon called Peg-Intron, but recent studies have indicated that Pegasys is slightly more effective and less likely to cause side effects than Peg-Intron (Washington Post, 10/17). Experts speculate that the majority of hepatitis C patients will be switched to treatment regimens involving pegylated interferon because the drug requires fewer self-injections, has fewer side effects and is more potent than interferon-alpha (Kaiser Daily HIV/AIDS Report, 9/26). The approval of Pegasys marks the FDA's second approval for a hepatitis drug in a month, following the authorization of a hepatitis B medicine in September (Washington Post, 10/17).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.