HCV RNA is undetectable in the 5 Cases who continued on treatment. Conclusion: The 3.5% incidence of hepatic decompensation/SAE was higher than in registration trials. Risk factors included higher baseline values of bilirubin and INR and lower values of albumin and creatinine, suggesting that advanced liver disease and wasting predispose to adverse events. Many patients with advanced liver disease require treatment.
Our data may help providers manage high risk patients. Disclosures: Kian Bichoupan – Consulting: Janssen Pharmaceuticals, Gilead Sciences Alyson Harty – Advisory Committees or Review Panels: Gilead; Consulting: Gil-ead, Jannsen, Acaria Pharmacy Michel Ng – Advisory Committees or Review Panels: abbvie; Speaking and Teaching: abbvie David B. Motamed – Advisory Committees or Review Panels: Gilead Maraviroc ic50 Pharmaceuticals Viktoriya Khaitova – Advisory Committees or Review Panels: Gilead, Johnson and Johnson Charissa Y. Chang – Consulting: Gilead, Vertex, Onyx Jennifer Leong – Advisory Committees or Review Panels: Gilead Thomas D. Schiano – Advisory Committees or Review Panels:
vertex, salix, merck, gilead, pfizer; Grant/Research Support: massbiologics, itherx Douglas Dieterich – Advisory Selleckchem HIF inhibitor Committees or Review Panels: merck, Idenix, Jans-sen ; Consulting: Gilead, BMS Andrea D. Branch – Grant/Research Support: Kadmon, Gilead, Janssen The following people have nothing to disclose:
Ponni Perumalswami, Rachana Yalamanchili, Donald Gardenier, Nancy Bach, Gene Y. Im, Lawrence Ku Aims: to assess in HCV genotype 1 patients treated by a combination therapy with telaprevir (TPV) or boceprevir (BOC), the influence of ribavirin plasma concentration on the sustained virological response and safety. Patients and methods: 66 HCV genotype 1 patients (1a 37.9%, 1b 53%) were MG-132 datasheet included in this non-randomized prospective study. All patients received a combination therapy with pegylated interferon alpha 2a plus ribavirin plus TPV (n=34) or BOC (n=32). Sustained virolog-ical response (SVR) was defined as undetectable viral load 24 weeks after end of treatment. Rapid virological response (RVR) was defined as undetectable HCV RNA after 4 weeks of BOC or TPV treatment. Ribavirin plasma concentrations (mg/L), hemoglobin level (g/dL), viral load (log-UI/mL) and creatinine clearance (mL/min) were collected during the treatment period and until 24 weeks after the end of treatment. Results: Fibrosis stage was METAVIR F0, F1 or F2 for 18 patients (27.3%), F3 for 16 patients (24.2%) and F4 for 32 patients (48.5%). The mean Fibroscan® value was 13.4 ± 8.5 KPa. In intent to treat analysis, the overall SVR rate was 55% (TPV: 61.8%, BOC: 46.9%, p<0.05). Ribavirin plasma concentration was not a predictive factor of SVR (1.87 ± 0.88 mg/L vs 1.95 ± 0.81 mg/L, respectively in SVR and in non SVR patients, p=0.7).