P1125 PHARMACOKINETIC-RESPONSE ANALYSIS OF FALDAPREVIR IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HCV GENOTYPE-1 INFECTION: A POOLED ANALYSIS OF TWO PHASE III TRIALS
2014
constrained countries for the foreseeable future. There are currently limited data on the use of BOC + PegIFN alfa-2a/RBV in treatmentnaive patients. Methods: Treatment-naive G1-infected patients with/without cirrhosis received 4 weeks PegIFN alfa-2a/RBV lead-in followed by BOC 800mg tid plus PegIFN alfa-2a/RBV. Treatment was stopped if HCVRNA ≥100 IU/mL at Week 12 or detectable at Week 24. This interim analysis explores factors predictive of qualification for an abbreviated 28-week regimen in non-cirrhotic patients. Results: 144 non-cirrhotic patients were included (88% G1b, 21% IL28B rs12979860 CC, 42% IL28B rs8099917 TT and 7% transition-to-cirrhosis). Overall, 118 patients (82%) had a ≥1 log10 drop in HCVRNA at Week 4 and 128 (89%) achieved ontreatment virological response (HCVRNA <15 IU/mL) at Week 24. A total of 84/144 (58%) patients achieved undetectable HCVRNA at Weeks 8 and 24 and therefore qualified for the shorter 28week treatment. MLR was used to explore the association between the following baseline factors and qualification for 28-weeks’ abbreviated treatment; G1 subtype, HCVRNA, age, weight, BMI, gender, IL28B genotype rs12979860/rs8099917 and fibrosis stage. Using backward elimination, factors remaining significant were G1a, lower HCVRNA, IL28B rs12979860 CC and rs8099917 TT genotype and no cirrhosis. SVR12 data will be presented at EASL.
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