FDA grants priority review to hepatitis C treatment for HIV patients
October 07 2004 12:00 AM ET
The Food and Drug Administration on Wednesday granted priority review status to an application to market Roche's combination hepatitis C treatment Pegasys and Copegus specifically for the treatment of chronic hepatitis C in patients also coinfected with HIV. The priority review status means that a decision by the FDA will come no later than February 2005. Both Pegasys (peginterferon alfa-2) and Copegus (ribavirin) have been approved for use either alone or together to treat hepatitis C in adults with no other chronic diseases. Roche officials say studies have shown the two drugs together suppressed HCV in 27% of HIV-HCV coinfected patients studied, compared to a 12% suppression rate in HCV-HIV coinfected patients through currently available treatments. About 300,000 HIV-positive people in the United States also have hepatitis C.