Posted: 5-Oct-2005 << BACK
Shorter Course Combination Therapy Approved in European Union for Certain Hepatitis C Patients with Genotype 1 and Low Viral Load
Schering-Plough Corporation today announced that the European Commission has approved revised dosing instructions allowing for a shorter, 24-week course of Pegitron(R) (1.5 mcg/kg once weekly) and Rebetol(R) (800 - 1,200 mg daily) combination therapy among a subgroup of patients with chronic hepatitis C virus (HCV) genotype 1 infection and low viral load (less than 600,000 IU/ml) who have achieved rapid virologic response, defined as undetectable virus (HCV-RNA negative) at week 4 of treatment that is maintained through week 24. The approval follows a positive opinion granted on July 28, 2005, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
Approval of this shorter combination treatment regimen cuts by half the duration of therapy for a subset of hepatitis C patients with genotype 1 and low viral load. This is the only treatment regimen approved in the European Union (EU) for a 24-week course of therapy in certain genotype 1 patients. In clinical studies supporting the approval, 92 percent of patients who met the criteria for early response achieved a sustained virologic response (SVR) with 24 weeks of treatment.
"Physicians now have the opportunity to consider a shorter course of therapy for their patients with hepatitis C genotype 1 who meet specific criteria," said Professor Stefan Zeuzem, M.D., Saarland University, Homburg, Germany, and lead investigator of the study supporting the approval. "Tailoring treatment so that those with an early response are treated for only 24 weeks rather than 48 weeks may make therapy more appealing to patients, providing comparable efficacy with better tolerability," he said.
"Approval of this shorter course of Pegitron and Rebetol combination therapy reflects the ongoing commitment of Schering-Plough to define optimal dose and treatment schedules to better meet the needs of hepatitis C patients," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
The Commission approval results in Marketing Authorization with unified labeling that is valid in the current EU 25 member states as well as in Iceland and Norway. Pegitron and Rebetol combination therapy was previously approved in the EU for a 48-week course of therapy for all patients with genotype 1 who exhibit virological response at week 12.
Study Results
The approved labeling change is based on results of a clinical study involving 235 patients with HCV genotype 1 and low viral load who received 24 weeks of combination therapy with Pegitron (1.5 mcg/kg once weekly) and Rebetol (800 - 1,400 mg daily); only two patients weighing more than 105 kg received the 1,400 mg dose. In the study, 41 percent of patients (97/235) had undetectable plasma HCV-RNA levels at week 4 and week 24 of therapy. Patients in this subgroup achieved a 92 percent (89/97) rate of sustained virological response. The high SVR in this group of patients was identified in an interim analysis and prospectively confirmed.
Genotype 1 virus is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infections among European patients overall, varying by geography. For patients with HCV genotypes 2 or 3, the EU labeling for Pegitron recommends that all patients be treated for 24 weeks. Patients infected with HCV genotype 4 are considered harder to treat and generally 48 weeks of therapy is recommended.
