The company hopes that the drug will prevent or delay hepatitis C disease progression and thus potentially reduce the occurrence of clinical events such as liver transplantation, liver cancer and death in patients infected with both diseases.
Dubbed the Endure study, the trial is targeted to enroll 448 patients at approximately 80 sites worldwide, including centers in the US, Europe and Canada.
According to sources cited by the company, approximately one third of HIV patients, or about 10 million people worldwide, are infected with both hepatitis C virus (HCV) and HIV. Liver disease caused by chronic hepatitis C is now a leading cause of morbidity and mortality among HIV-infected patients in the developed world.
Peg-Intron is currently approved in the United States as monotherapy and for use in combination therapy with Rebetol for the treatment of chronic hepatitis C in patients with compensated liver disease who are at least 18 years of age.
“The principal goal for treating patients infected with hepatitis C is viral eradication, with pegylated interferon and ribavirin combination therapy being the current standard of care. However, many co-infected patients fail to respond to this combination therapy and there currently is no approved treatment for such patients,” said Dr Mark Sulkowski, associate professor of medicine at Johns Hopkins University School of Medicine, Baltimore, and co-lead investigator of the study.