PEG-IFN lambda: Phase IIb data

Data from the Phase IIb portion of the international Phase II EMERGE trial in 526 treatment-naïve patients with chronic HCV infection showed that 120, 180 and 240 µg weekly subcutaneous PEG-interferon lambda plus Copegus ribavirin led to significantly higher cEVR rates, defined as undetectable HCV RNA levels at week 12, in patients with HCV genotypes 1 and 4 infections vs. Pegasys peginterferon alfa-2a plus Copegus (55%, 55.9% and 56.3%, respectively, vs. 37.9%; p<0.05 for all). Low-, mid- and high-dose PEG-interferon lambda plus Copegus also led to higher rapid virologic response (RVR) rates, defined as undetectable HCV RNA levels (<25 IU/mL) at week 4, vs. Pegasys plus Copegus (6%, 14.7% and 16.5%, respectively, vs. 5.8%).

In patients with HCV genotypes 2 and 3 infections, low-, mid- and high-dose PEG-interferon lambda plus Copegus led to similar cEVR rates at week 12 vs. Pegasys plus Copegus (90%, 96.6% and 83.3%, respectively, vs. 86.2%). Mid- and high-dose PEG-interferon lambda plus Copegus led to significantly higher RVR rates at week 4 vs. Pegasys plus Copegus (75.9% and 66.7%, respectively, vs. 31%, p<0.05 for both), but low-dose PEG-interferon lambda plus Copegus non-significantly improved RVR (43.3%). Furthermore, there were fewer flu-like and musculoskeletal symptoms associated with PEG-interferon lambda compared to Pegasys. Data were presented at the European Association for the Study of the Liver meeting in Berlin. ...