PEGASYS breaks new ground
PEGASYS, the most prescribed hepatitis C medication in the US, has become the first pegylated interferon to be approved by the US FDA for the treatment of chronic hepatitis B (CHB). The drug, from Roche, was approved in the EU in February of this year.
PEGASYS, the most prescribed hepatitis C medication in the US, has become the first pegylated interferon to be approved by the US FDA for the treatment of chronic hepatitis B (CHB). The drug, from Roche, was approved in the EU in February of this year.
The approvals are based on one of the largest clinical development programs in patients with chronic hepatitis B (three global studies in more than 1,500 patients from 19 countries), and recognise that a finite course of PEGASYS is associated with a favourable lasting and sustained response in patients compared with current standards of care (lamivudine). They have been conducted in patients with both forms of the disease: HBeAg-positive (most common in Asia and north Europe) and HBeAg-negative chronic hepatitis B (the more difficult to treat form of the disease found mainly in the Mediterranean).
The Centers for Disease Control in the US estimate that 1.25 million people in the US are chronically infected with hepatitis B, and WHO estimates put the worldwide figure as high as 350 million.
'PEGASYS can now be considered as another option for first-line therapy for patients with chronic hepatitis B, with the aim of achieving a sustained and durable response following a finite course of therapy,' said Dr Michael Fried, professor of medicine and director of hepatology at the University of North Carolina and a principal investigator in one of the key PEGASYS Phase III trials. 'Alternative treatments are generally continued for prolonged periods, thus raising the risk of antiviral resistance.'