In this study, we investigated the outcomes of retreatment HDAC inhibitors in clinical trials in HCV genotype 1 patients who relapsed after 24-week
PEG-IFN/RBV combination therapy in Taiwan. We also investigated the predictive value of IL28B gene genotype for on-treatment viral kinetics and treatment outcomes. In Taiwan, since November 2009, the Bureau of National Health Insurance launched a reimbursement program for the retreatment of CHC patients who had relapse after a 24-week peginterferon plus RBV combination therapy. We defined virologic relapse in patients who had undetectable serum HCV RNA at the end of 24-week treatment and had recurrent hepatitis C viremia during the posttreatment follow-up period. We consecutively enrolled patients with CHC relapse into this study. Inclusion criteria were: age > 18 years old, presence of anti-HCV antibody,
detectable serum HCV RNA level by a real-time reverse transcription polymerase chain reaction (RT-PCR) analysis (Cobas TaqMan HCV Test®, version 2.0; Roche Diagnostics, Apoptosis antagonist Branchburg, NJ, USA), HCV genotype 1 by a reverse hybridization assay (Inno-LiPA HCV II®; Innogenetics, Ghent, Belgium), and serum ALT level greater than the upper limit of normal (ULN). Patients with the following diseases or conditions, and not suitable for anti-HCV therapy were excluded: anemia (hemoglobin level < 13 g/dL for men and < 12 g/dL for women), neutropenia (neutrophil count < 1500 cells/mm3), thrombocytopenia (platelet count < 90 000 cells/mm3), coinfection with hepatitis B virus or human immunodeficiency virus, alcohol abuse (daily alcohol consumption > 20 g/day), decompensated cirrhosis (Child-Pugh class B or C), autoimmune liver disease, liver transplantation, neoplastic disease, evidence of drug abuse, pregnancy, and poorly controlled autoimmune/heart/lung/hematology/renal Methocarbamol diseases. This prospective observational clinical study was conducted since November 2009 at National Taiwan University Hospital, Taipei, Taiwan. Written informed consent before enrollment
was obtained from all patients in accordance with ethical committee approved protocols, the principles of the Declaration of Helsinki of 1975, and the International Conference on Harmonization for Good Clinical Practice. Eligible patients received 48 weeks of weekly subcutaneous injections of peginterferon alfa (Pegasys®, 180 mcg, F. Hoffmann-La Roche, Basel, Switzerland; or PegIntron® 1.5 mcg per kilogram of body weight, Merck, Whitehouse Station, NJ, USA) and a divided daily weight-based oral RBV (Copegus®, F. Hoffmann-La Roche; or Rebetol®, Merck; 1000–1200 mg per day). Patients received 48-week therapy on an outpatient basis and then an additional 24-week follow-up posttreatment. Visits occurred at week 1, 2, 4, and then monthly following initiation of therapy to assess the efficacy.