Abstract
with pegylated interferon a-2a and ribavirin (PR) in patients infected with chronic HCV. Futility rules may prevent unnecessary prolongation of therapy, minimising adverse effects and limiting resistance emergence. We explored potential futility rules for patients treated with faldaprevir. Methods: In STARTVerso1 and -2, treatment-naive patients infected with HCV genotype-1 were randomised to 48 weeks (W) of PR plus: placebo for 24W (Arm 1); faldaprevir 120mg QD for 12W or 24W (Arm 2); or faldaprevir 240mg QD for 12W (Arm 3). Patients in Arms 2 and 3 stopped all treatment at W24 on achievement of early treatment success (HCVRNA 100 or >1,000 IU/mL at week 4 or 12 have high probabilities of predicting treatment failure; NPVs are similar using the W4 or W12 time point.
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