Hepatitis C Non-Responders Have a Second Chance with PEGASYS(R)

Studies Show That Patients May be Re-treated Successfully.

Hepatitis C (HCV) patients with difficult-to-treat disease, who do not respond to previous courses of therapy with either conventional interferon or peg-interferon alfa-2b[1] combination therapy, may now have an improved chance to be cured if they are re-treated with PEGASYS(R) plus COPEGUS(R). Two studies to be presented at the American Association for the Study of Liver Diseases meeting in Boston show that PEGASYS combination therapy is effective in non-responders to previous therapy. Higher dose strategies for patients not responding to previous conventional interferon combination therapy One study reports that more than one-third of hepatitis C genotype 1 patients who previously failed to respond to conventional interferon plus ribavirin achieved a sustained virological response (SVR) following re-treatment with a 12-week induction dose of PEGASYS. Seventy-two patients were randomised into one of three arms where they received the standard dose of 180 microg or an increased dose of either 270 or 360 microg PEGASYS weekly for 12 weeks followed by a 180 microg dose of PEGASYS for the remaining 36 weeks. Throughout the trial, patients received either 1000 or 1200 mg of COPEGUS daily. There was a clear dose response with increasing doses of PEGASYS(R) with patients in the 360 microg induction dose arm achieving a 37.5% SVR. This is important as previous studies have reported SVRs of only around 10% in these difficult to treat patients. (i) “These data show that a higher induction dose may be an effective treatment strategy for patients who are non-responders to previous therapy,” said Dr. Moises Diago, Hepatologist at Hospital General Universitario, Valencia, Spain and lead author of the study. “The SVRs that were achieved in this study with PEGASYS and COPEGUS are encouraging and provide patients with a second chance to achieve viral eradication.” The second study suggests that the positive results seen in re-treating conventional interferon non-responders with PEGASYS and COPEGUS may also be achieved in patients not responding to previous peg-interferon alfa-2b combination therapy. Pilot study provides look at effectiveness of PEGASYS in peginterferon alfa-2b non-responders Dr. Norman Gitlin from Emory University in Atlanta, Georgia will present the results of a small single centre study examining the SVR that was achieved by giving PEGASYS plus COPEGUS to patients who failed to respond to a course of therapy with peg-interferon alfa-2b and ribavirin. In the 31 patients that Dr. Gitlin and colleague report on, 32% overall achieved an SVR and pre-existing cirrhosis did not preclude a successful response. The trial studied patients who were not responsive to peg-interferon alfa-2b combination therapy at 12 to 24 weeks, who were then treated with a fixed 180 microg dose of PEGASYS per week and either 1000 or 1200 mg of COPEGUS daily. Cirrhosis was present in 32% of patients enrolled in the trial and 94% of all patients had genotype 1 HCV – the most difficult-to-treat form of the virus. “Patients who do not respond to the current standards of care have few if any re-treatment options,” said Dr. Gitlin. “The medical community has been sceptical of the value of re-treating patients who’ve already received a pegylated interferon, however, our experience suggests that the combination of PEGASYS and COPEGUS can provide higher SVRs than we’ve seen previously in this patient population, and that’s good news for patients.” “Roche has encouraged physicians around the world to look at strategies that will give patients the best possible outcome,” said Ciro Caravaggio, Hepatitis Franchise Leader at Roche. “The interim results of the high induction dose study were a significant factor in the design of our ongoing REPEAT study in peg-interferon alfa-2b non-responders, and Dr. Gitlin’s study also gives us an interesting preview of the results we may achieve in REPEAT,” he added. Roche’s ongoing commitment to finding solutions for patients who have not responded to earlier therapy To support the growing patient population that is non-responsive to the earlier pegylated interferon treatment, Roche initiated a year ago the first global trial to study the efficacy of the new generation pegylated interferon combination therapy against the earlier one. This trial is known as REPEAT, which stands for “REtreatment with PEGASYS in pATients not responding to prior peginterferon alfa-2b/ribavirin combination therapy”. The REPEAT study will evaluate the efficacy and safety of the combination of PEGASYS and COPEGUS given for a longer, 72-week period, as well as examining the role of a 12-week induction regimen in this population. Currently, 106 treatment sites in Belgium, Brazil, Canada, France, Germany, Greece, Italy, Portugal, Spain, Sweden, Switzerland, Turkey, UK and the USA are enrolling 900 patients for this trial and enrollment is expected to be completed by the beginning of next year. To enrol in REPEAT, patients must be diagnosed with chronic hepatitis C and have failed to achieve a response after at least 12 weeks of therapy with standard doses of peg-interferon alfa-2b and ribavirin. In addition, there are nearly 50 other trials that have begun in 20 countries where PEGASYS and COPEGUS are being studied in patients who have failed to respond to other therapies.