Roche hepatitis and HIV combination approved
pharmafile | February 9, 2005 | News story | Sales and Marketing |
Roche's Pegasys has become the first treatment licensed for patients suffering hepatitis C and HIV at the same time.
The European Commission has approved it in combination with hepatitis C drug ribavirin (Roche's Copegus) for the treatment of chronic hepatitis C in clinically stable patients co-infected with HIV.
Research suggests that as many as 30% of HIV patients are also infected with hepatitis C (HCV).
The newly approved combination does not act directly on the HIV virus but is compatible with antiviral drugs and has a positive affect on the virological control of HIV.
Current standard therapy is an interferon/ribavirin combination, but the company's APRICOT study demonstrated its dual therapy was more effective.
Dr Francesca Torriani, associate professor of medicine, Antiviral Research Centre, University of California, and the study's lead author welcomed the approval.
"It is clearly important that we treat these patients as we now know that the leading cause of death in HIV-HCV co-infected patients is liver disease as a result of hepatitis C. With great strides being made in potent antiretroviral therapy, allowing HIV-infected patients to live longer, we don't want to see those benefits disappear by the emergence of fatal liver disease."
The APRICOT study showed 40% of patients treated with Pegasys and ribavirin achieved a sustained virological response (which indicates a cure) compared with 20% of patients treated with Pegasys alone and 12% of patients treated with conventional interferon/ribavirin.
Pegasys is the world's biggest selling hepatitis C therapy, and saw sales increase by 69% to over CHF1 million in 2004.
The new licence follows another EU approval for the treatment of hepatitis C patients with persistently 'normal' liver enzymes, as well as several other approvals worldwide, with further milestones expected this year.
