Early results evaluating re-treatment strategies using Pegasys plus Copegus show benefit in patients who had been unsuccessfully treated with another pegylated interferon (Peg-Intron plus ribavirin). This means that hope may be at hand for the large and growing group of patients who could not initially be cured of their Hepatitis C virus.
Preliminary results from the large international trial called Repeat1 show that 47% of patients treated with the standard combination of Pegasys plus Copegus have undetectable amounts of virus or have a significant reduction in viral load at the important 12 week assessment. In addition, 64% of patients who received an innovative induction dose of Pegasys achieved this early viral response, claims a Roche release.
The results presented at the American Society for the Study of the Liver (AASLD) reflect findings from the first 12 weeks of therapy from this ongoing study. These early results typically act as an excellent indicator of whether or not a person will be cured of their disease after completing the full course of therapy.
"These are very positive results for patients who have not responded to previous therapy," said Professor Patrick Marcellin, from the Hospital Beaujon, France and one of the lead investigators of the study. "Previously these patients would have been considered difficult to treat; now there is hope for a cure."
"This is a further example of Roche defining new treatment strategies resulting in optimal therapeutic approaches for the Hepatitis C patient population. These new results have pioneered a new solution for patients who have not responded to first-line treatments," said Eduard Holdener, global head, Pharma Development, Roche.
One of the biggest challenges in the treatment of Hepatitis C patients is to find treatment options for those who do not respond to primary treatments. These new data become available at a time when a report from a large study mandated by the US health authority demonstrated that Peg-Intron was not able to generate sustained viral response in more than 50% of patients receiving Peg-Intron as a first line treatment.
The purpose of the study is to evaluate the efficacy and safety of Pegasys and Copegus combination therapy in patients who were unable to be cured using PegIntron combination therapy. In this innovative study, Pegasys and Copegus are given for the traditional 48 week period or a longer 72 week period, as well as with or without an induction dose of Pegasys for the first 12 weeks of therapy. 950 patients were randomised in the Repeat study from Europe, North America and Latin America.
Pegasys is the most frequently prescribed pegylated interferon for patients infected with Hepatitis C. An extensive clinical study programme has demonstrated its safety and efficacy in the broadest range of patients including those with difficult-to-treat disease. The benefits of Pegasys are derived from its unique 40 kilodalton branched peg molecule which ensures sustained viral control for patients throughout the once-weekly dosing interval.
In addition to becoming the only treatment approved for Hepatitis C patients who are co-infected with HIV, Pegasys is also the only approved medication in the EU for Hepatitis C patients with normal levels of alanine aminotransferases (ALT) - a patient population previously thought not to benefit from treatment.