The European Commission approval of this expanded indication for Pegintron and Rebetol results in marketing authorization with unified labeling that is valid in the current EU 27 member states, as well as in Iceland and Norway. The drugs were previously approved in the EU for treating adult patients with chronic hepatitis C alone.
Approximately 40% of the estimated 2.5 million people living with HIV in Europe are coinfected with the hepatitis C virus (HCV), according to the World Health Organization.
“Effective treatment of HCV is critically important for people coinfected with HIV, as liver disease caused by chronic HCV infection is now a leading cause of morbidity and mortality among these patients,” said Dr Josep Mallolas, from the infectious diseases service at Hospital Clinic Universitari de Barcelona, Spain.
According to the company, in two clinical studies, HCV/HIV co-infected patients treated with Pegintron combination therapy achieved higher statistically significant sustained virological response (SVR) rates overall compared to conventional interferon alfa-2b and ribavirin. SVR is defined as undetectable HCV-RNA six months following the end of treatment and is the standard measure of treatment success for hepatitis C.