S-P's Pegintron combo therapy gets tentative EU approval

US drug major Schering-Plough says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended the approval of combination therapy with Pegintron (peginterferon alfa-2b, 1.5mcg/kg once-weekly) and Rebetol (ribavirin, 800mg - 1,200mg daily) for the treatment of previously-untreated adult patients with chronic hepatitis C who are co-infected with clinically-stable HIV. Around 40% of the estimated 2.5 million people living with HIV in Europe are co-infected with the hepatitis C virus (HCV), according to the World Health Organization.

In two clinical studies, HCV/HIV co-infected patients treated with this combination therapy achieved higher statistically-significant rates of sustained virological response (undetectable HCV-RNA six months following the end of treatment) compared to conventional interferon alfa-2b and ribavirin.