Roche gets US nod for Pegasys combo therapy for hep C in HIV patients

EPP News Bureau - Mumbai

Roche announced that the US Food and Drug Administration (FDA) has approved Pegasys and Copegus for the treatment of chronic hepatitis C in patients co-infected with hepatitis C and HIV.

According to the press release, this Pegasys combination therapy is effective in leading to a sustained virological response (SVR, indicative of a cure), providing a compelling reason to consider treatment in this previously undertreated patient group.

Pegasys combination therapy is now the first and only regimen approved in the US for hepatitis C treatment in patients with HIV, it added. 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.

‘‘Roche is proud to have delivered the ground breaking research work that has led to the approval of Pegasys (peginterferon alfa-2a (40KD)) and Copegus (ribavirin) for the treatment of chronic hepatitis C in patients with HIV-HCV co-infection in the US, and recently in Europe. Pegasys and Copegus bring a much needed treatment option for patients with both HCV and HIV, a devastating disease combination,’’ said William M Burns, CEO of Roche’s Pharmaceutical Division.

‘‘Roche has a strong heritage ofdeveloping anti-viral medications and the recent approvals worldwide further reinforce our commitment to finding innovative solutions for hepatitis patients.’’

Co-infection has emerged as a major public health concern with data suggesting that globally about 30 per cent 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.

‘‘For the first time, the 300,000 Americans who are co-infected with hepatitis C and HIV have an approved hepatitis C treatment option. This is a very important advance for the HIV community,’’ said Jeffrey Smith, director, Clinical Research, American Foundation for AIDS Research (amfAR).

According to Dr Francesca Torriani, associate professor of Medicine, Antiviral Research Centre, University of California and the lead author of the APRICOT study, ‘‘It is clearly important that we successfully treat these patients as we now know that, in HIV-HCV co-infected patients, liver disease due to hepatitis C is the leading cause of death and hospitalisation. With so much improvement in patient’s quality of life and survival thanks to potent antiretroviral therapy, the HIV community and providers don’t want to see those benefits disappear by the emergence of fatal liver disease.’’