The study protocol was in compliance with the
Good Clinical Practice Guidelines and the 1975 Declaration of Helsinki and was approved by the Institutional Review Board. Each patient gave informed consent before participating in this trial. Patients were divided into two groups: 20 (25%) patients were allocated to a 12-week regimen of triple therapy (telaprevir [MP-424], PEG-IFN, and ribavirin) (the T12PR12 group), and 61 patients (75%) were assigned to a 24-week regimen of the same triple therapy for 12 weeks followed by dual therapy of PEG-IFN and ribavirin for 12 weeks (the T12PR24 group). All of 81 patients met the following inclusion and exclusion criteria: (1) diagnosis of chronic hepatitis
C. (2) HCV-1 confirmed by sequence analysis. (3) HCV RNA levels of ≥5.0 log IU/mL determined http://www.selleckchem.com/products/birinapant-tl32711.html by the COBAS TaqMan HCV test (Roche Diagnostics, Tokyo, Japan). (4) Japanese (Mongoloid) ethnicity. (5) Age at study entry of 20-65 years. (6) Body weight ≥35 kg and ≤120 kg at the time IWR-1 mw of registration. (7) Lack of decompensated liver cirrhosis. (8) Negativity for hepatitis B surface antigen (HBsAg) in serum. (9) Negative history of HCC. (10) No previous treatment for malignancy. (11) Negative history of autoimmune hepatitis, alcohol liver disease, hemochromatosis, and chronic liver disease other than chronic hepatitis C. (12) Negative history of depression, schizophrenia or suicide attempts, hemoglobinopathies, angina pectoris, cardiac insufficiency, myocardial infarction or severe arrhythmia, uncontrollable hypertension, chronic renal dysfunction or creatinine clearance of ≤50 mL/minute at baseline, diabetes requiring treatment or fasting glucose level of ≥110 mg/dL, autoimmune disease, cerebrovascular medchemexpress disorders, thyroidal dysfunction uncontrollable by medical treatment, chronic pulmonary disease, allergy to medication or anaphylaxis at baseline. (13) Hemoglobin level of ≥12 g/dL, neutrophil count ≥1500/mm3, and platelet count of ≥100,000/mm3 at baseline. Pregnant or breast-feeding
women or those willing to become pregnant during the study and men with a pregnant partner were excluded from the study. Furthermore, 72 of 81 patients were followed for at least 24 weeks after the completion of triple therapy. The treatment efficacy was evaluated by HCV-RNA negative at the end of treatment (end-of-treatment response) and 24 weeks after the completion of therapy (sustained virological response), based on the COBAS TaqMan HCV test (Roche Diagnostics). Telaprevir (MP-424; Mitsubishi Tanabe Pharma, Osaka, Japan) was administered at 750 mg or 500 mg three times a day at an 8-hour (q8) interval after the meal. PEG-IFNα-2b (PEG-Intron; Schering Plough, Kenilworth, NJ) was injected subcutaneously at a median dose 1.5 μg/kg (range: 1.3-2.