Roche Files Application To Market Drug Combination To Treat HIV, Hepatitis C Co-Infected Patients

Pharmaceutical company Roche announced on Thursday that it has filed an application with FDA to market a drug combination therapy to treat patients co-infected with HIV and chronic hepatitis C, the AP/Springfield News Sun reports. FDA granted the company fast-track status for its application to market the hepatitis C drugs Pegasys and Copegus as a combination therapy because the agency said that HIV/hepatitis C co-infection is an "unmet medical need," according to the AP/News Sun. The two drugs already are FDA-approved to treat chronic hepatitis C infections in patients without HIV (AP/Springfield News Sun, 9/2). Approximately 300,000 people living with HIV/AIDS in the United States are co-infected with hepatitis C. 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. Twelve percent of co-infected patients treated with Copegus and an older form of the drug interferon reported undetectable levels of hepatitis C during the same time period. The newer combination therapy also did not appear to interfere with the effects of antiretroviral drug therapies, according to Reuters (Reuters, 9/2). However, 8% of study participants reported "serious" adverse effects related to the Pegasys/Copegus therapy, compared with 5% of patients treated with Copegus and interferon and 10% of patients who received Pegasys monotherapy, according to a Roche release. The company hopes to gain FDA approval for the drugs sometime next year, according to Gary Zieziula, Roche's vice president of commercial operations. This is the first application filed by a pharmaceutical company to treat patents co-infected with hepatitis C and HIV, according to Roche. The company filed a similar application with the European Medicines Agency in May (Roche release, 9/2).