The European Medicines Agency has cleared a shorter treatment course of US drugmaker Schering-Plough’s combination treatment for chronic hepatitis C, Peg-Intron (pegylated interferon alfa-2b plus ribavirin) and Rebetol (ribavirin plus interferon alfa-2b). This follows a positive opinion issued by the EMEA’s Committee for Medicinal Products for Human Use in July.
A shorter regimen of Peg-Intron and Rebetol combination therapy for patients with hepatitis C genotype 1, specifically those who are classed as early-responders with a low viral load, offers significant advantages over previous treatments. It cuts the duration of therapy in half, and represents the only regimen cleared in the European Union for a 24-week course of therapy.
Approval was based on data from a clinical study showing that 92% of patients who met the criteria for early response achieved a sustained virologic response 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," noted the trial’s lead investigator, Professor Stefan Zeuzem from Saarland University in Homburg, Germany. "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 added.
Peg-Intron and Rebetol combination therapy for chronic hepatitis C was first approved in the EU in March 2001. In the second quarter of this year, sales of Rebetol (ribavirin plus interferon alfa-2b) grew 3% to $91 million and Peg-Intron (pegylated interferon alfa-2b plus ribavirin) turnover jumped 26% to $182 million, and the company is hoping that this new regimen will lift sales substantially.