Regulatory

Roche hepatitis C drugs win fast review for use in HIV patients

Last Updated: 2004-10-06 15:57:19 -0400 (Reuters Health)

NEW YORK (Reuters) - Roche Holding SA on Wednesday said U.S. regulators would give priority review to whether the company's combination treatment for hepatitis C should be used by patients also infected with HIV.

Roche's injectable interferon Pegasys and oral ribavirin are already approved for the treatment of hepatitis C virus infection. Since a significant percentage of people infected with HIV are also infected with the hepatitis C virus, Roche has asked for permission to market the dual therapy for this population.

Drugs given priority review status are reviewed by the U.S. Food and Drug Administration within six months, rather than the typical review time of up to one year.