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Faldaprevir is a potent, once-daily hepatitis C virus (HCV) NS3/4A protease inhibitor with antiviral activity in vitro. In the current industry-sponsored, phase IIb trial, investigators assessed its efficacy in achieving sustained virologic response (SVR) in combination with peginterferon (PEG; 180 µg weekly) and ribavirin (RBV; 1000–1200 mg daily) in 429 treatment-naive patients infected with HCV genotype 1. Participants were randomized in a 1:1:2:2 ratio to receive one of the following regimens (each followed by 24 weeks of PEG/RBV only):
Placebo once daily plus PEG/RBV for 24 weeks;
Faldaprevir once daily (120 mg) plus PEG/RBV for 24 weeks with a 3-day lead-in of placebo plus PEG/RBV;
Faldaprevir once daily (240 mg) plus PEG/RBV for 24 week…