FDA Grants Roche Priority Review Status for Drug Combination To Treat HIV, Hepatitis C Co-Infected Patients
Pharmaceutical company Roche announced Wednesday that FDA had granted it priority review status for a drug combination therapy used to treat patients co-infected with HIV and chronic hepatitis C, Reuters reports. The hepatitis C drugs Pegasys and Copegus will be reviewed within six months, compared with the usual review time of up to one year (Reuters, 10/6). FDA last month granted Roche fast-track status for its application to market the drugs as a combination therapy because the agency said that HIV/hepatitis C co-infection is an "unmet medical need." The two drugs already are FDA approved to treat chronic hepatitis C infections in patients without HIV. The application was based on a study sponsored by Roche that reported undetectable levels of hepatitis C in 40% of HIV-positive study participants who were treated with the Pegasys/Copegus combination (Kaiser Daily HIV/AIDS Report, 9/7). "There are currently no approved treatments for the approximately 300,000 people in the United States with HIV who are infected with hepatitis C," Juan Carlos Lopez-Talavera, Roche senior medical director, said, adding, "Roche invested in the research to pursue an indication for Pegasys combination therapy in co-infected patients because we recognized that the need is urgent. Liver failure resulting from chronic hepatitis C is now one of the leading causes of death in people with HIV" (Roche release, 10/6).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.