Swiss giant, Roche, has received a boost on news that the US Food and Drug Administration had approved Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) for the treatment of chronic hepatitis C patients also infected with HIV.
Pegasys – the most prescribed hepatitis C medication in the US – was first approved in the US back in 2002 for use alone and in combination with Copegus for the treatment of adults with chronic hepatitis C [[17/10/02a]], and saw total 2004 sales rise 69% to 1.2 billion Swiss francs [[02/02/05a]]. This new FDA approval, which was based on the results of the 868-patient Apricot trial, in which 40% of patients receiving the Pegasys/Copegus combination achieved a sustained virological response (which is indicative of a cure), compared with 20% of patients treated with Pegasys monotherapy and 12% of patients treated with conventional therapy [[12/02/04d]], [[10/02/04d]], follows a recent flurry of approvals by the European Commission. The drug was approved on Friday to treat chronic hepatitis C in patients co-infected with hepatitis C and HIV, and has also won the thumbs up in the treatment of hepatitis C patients with persistently “normal” liver enzymes [[12/11/04d]]. Pegasys has also won several approvals worldwide for the treatment of chronic hepatitis B [[24/01/05e]].
Roche says that the Pegasys combination therapy is now the first and only regimen approved in the US for hepatitis C treatment in patients with HIV. The firm notes that hepatitis C has become the most frequent cause of liver disease in HIV patients, and in some regions, may be a leading cause of death. In addition, it says that co-infection has emerged as a major public health concern, with data suggesting that around 30% of HIV-infected patients are co-infected with HCV. Hepatitis C and HIV are the two most prevalent blood-borne infections in the United States.