HEP3002 is an ongoing, open-label, early access program of telaprevir (TVR) in 16 countries, for patients with genotype 1 hepatitis C infection with severe fibrosis or compensated cirrhosis. Methods: Liver biopsy or non-invasive tests (Fibroscan in 1040 patients) showing severe fibrosis or cirrhosis were required at entry.1587 patients were treated with TVR, pegylated interferon-alpha (P) and ribavirin (R, RBV) for 12 weeks, followed by PR. Use of iron supplements, erythropoietin (EPO) AZD9291 chemical structure and blood transfusions was permitted. Grade 1-4 anemia

included the clinically significant adverse event terms (SSC) of anemia or hemoglobin (Hb) reduction. All analyses selleck kinase inhibitor were on the intent-to-treat (ITT) population, using 16 weeks of data. Continuous variables were used in the multivariate analyses to predict anaemia. Results: Mean age was 53 years and mean weight 78kg; 64% were male and 98% Caucasian, 66% had HCV RNA levels >800, 000 lU/mL, 47%/53% had severe fibrosis/cirrhosis, 22% had genotype 1a. Up to Week 16, 59% of patients developed grade 1-4 anemia, with 3 1% grade 3-4 cases; 630 patients (40%) dosereduced RBV, 332 (21%) received EPo157 (10%) were transfused, 14 (1%) received iron-based

products and 45 (3%) discontinued treatment because of anemia. Results by baseline disease stage are shown below. There were reductions in Hb below 10 g/dL in 48% of patients. In a multivariate analysis, the four strongest predictors of Hb <10 g/dL at any time on treatment were female sex (OR=1.69, 95% Cl 1.27-2.27, p=0.0004), age >65 years (OR=2.31, 95% Cl 1.46-3.65,

p=0.0003), low baseline Hb (OR=1.08, 95% Cl 1.06-1.09, p<0.0001) and higher weight-based dosing of RBV (OR=1.13, 95% Cl 1. 05-1.21, p=0.0005). Baseline Fibroscan test results were not a significant predictor of anemia. Conclusions: In this TVR early access program for patients with severe fibrosis or compensated cirrhosis, grade 3 or 4 anemia was reported in 31% of patients, but discontinuation of TVR for anemia medchemexpress was rare (3%). Anemia was normally managed by RBV dose reduction, transfusion or the use of EPo. Type of anemia Definition F3 patients (n=746) F4 patients Grade 1 Hb 10-10.9 or 2.5-3.4g/dL decrease 81(11%) 76 (9%) Grade 2 Hb 9-9.9 g/dL or 3.5-4.4 g/dL decrease 116(16%) 169 (20%) Grade 3 Hb 7-8.9 or >4.5 g/dL decrease 188 (25%) 238 (29%) Grade 4 Hb <7 g/dL 26 (3%) 35 (4%) Discontinued TVR for anemia 14(2%) 31(4%) Anemia as serious AE 32 (4%) 43 (5%) Disclosures: Simone I.