New Pegasys licence gives patients ‘second chance for a cure’
pharmafile | December 4, 2008 | News story | Sales and Marketing |Â Â Roche, hepatitisÂ
Hepatitis C patients who don't at first respond to treatment with Pegasys will now be able to receive the drug for a second attempt to 'cure' the disease over a longer period.
The new European licence makes Pegasys the first pegylated interferon that can be given to patients for up to 72 weeks, extending its use beyond the current 48-week limit.
The drug has been approved in combination with Copegus (ribavirin) for the re-treatment of patients who did not respond fully to an initial course of interferon alpha (pegylated or non-pegylated), either alone or in combination with ribavirin.
A significant number of patients who receive the treatment do not achieve sustained virological response (SVR), which is widely equated to a cure.
This has resulted in a large and growing population of patients who need alternative treatments, but until now, neither Pegasys nor Schering-Plough's rival PegIntron has been available beyond a 48-week period of treatment.
Pegylated rivals
Pegylated interferon alpha is the newer, longer-lasting form of the drug, and is available as Roche's Pegasys and Schering-Plough's PegIntron.
Pegasys is the leading treatment, with sales of $987 million in the first nine months of 2008, up 6% compared to the same period last year, ahead of PegIntron which earned $689 million.
The hepatitis C virus (HCV) is transmitted primarily through blood or blood products, and the disease affects 180 million people worldwide, making it over four times more prevalent than HIV.
HCV is a leading cause of cirrhosis, liver cancer and liver failure in the world, despite the fact that many patients can be cured. In Europe alone, HCV is estimated to cause more than 86,000 deaths every year.
"This new indication for Pegasys plus Copegus is another demonstration of Roche's commitment to extend the promise of a cure to as many chronic hepatitis C patients as possible," said William Burns, head of Roche's pharma division.
"Our approach is to optimise and individualise treatment to increase patients' chance of success with Pegasys and Copegus, while establishing them as the backbone for combination with novel agents in development, both by Roche and through external partnerships and collaborations."
'Personalised healthcare'
The new label for treatment-experienced patients contains several aspects of personalised healthcare, an area that Roche is keen to develop.
The recommended length of peginterferon alfa-2a treatment for patients is based on their virus genotype and type of prior treatment. For patients with genotype 1 virus who did not respond to initial treatment with pegylated interferon and ribavirin, it is recommended that they be re-treated with peginterferon alfa-2a for an extended period of 72 weeks.
A patient's virus levels must be measured after 12 weeks of treatment, as this is a very accurate indicator of whether a full course of treatment is likely to result in a cure.
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