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news.European regulators have recommended the approval of revised dosing instructions for Schering-Plough Corporation's hepatitis C combination therapy.
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The Committee for Medicinal Products for Human Use (CHMP) is supporting the introduction of a shorter, 24-week course of weight-based Pegintron and Rebetol daily combination therapy among a subgroup of patients with hepatitis C genotype 1 infection and low viral load.
The announcement comes after a clinical study revealed that a 92% sustained virologic response was achieved with 24 weeks of treatment among the 41% of patients who met the criteria for early response.
Pegintron and Rebetol were 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. Approval of this shorter combination treatment regimen is expected to halve the duration of therapy for a subset of hepatitis C patients with genotype 1 and low viral load.