P1226 NS3 Q80K DID NOT IMPACT EFFICACY OR TREATMENT-EMERGENT RESISTANCE PATTERNS IN HCV GENOTYPE 1-INFECTED PATIENTS RECEIVING FALDAPREVIR + PEGINTERFERON/RIBAVIRIN IN THREE PHASE III TRIALS

Methods: Twenty patients were randomized to receive 100 or 200mg VX-135 QD with RBV for 12 weeks. HCVRNA levels were measured using COBAS TaqMan (v.2.0, Roche). The NS5B region was sequenced before, during, and after treatment to monitor for S282T and other potential resistant variants observed in >1 patient. Results: Sequence data were available for all patients at baseline, 2 patients at Week 1 of treatment, and 13 patients who relapsed (1 additional pending). The S282T variant was not observed by population sequencing in any patient (with available data) at any time point. No additional potential resistant variants were identified in patients who relapsed. More sensitive sequencing analyses are underway. Conclusions: These results demonstrate that in these 13 patients who relapsed after 12 weeks of treatment with VX-135 and RBV, no VX-135 resistant variants were detected by population sequencing.