title: A pilot study of add-on oral hypoglycemic agents in treatment-naïve genotype-1 chronic hepatitis C patients receiving peginterferon alfa-2b plus ribavirin.
abstract: OBJECTIVE
  Insulin resistance (IR) affects sustained virological response (SVR) to peginterferon alfa plus ribavirin (PR) in patients with chronic hepatitis C (CHC). Whether add-on oral hypoglycemic agents (OHAs) to PR improve SVR remains unclear; therefore, we conducted a prospective, randomized pilot trial on 23 consecutive patients with genotype 1 CHC and IR in Taiwan.
  
  
  METHODS
  Patients were randomized to receive acarbose (Arm A; n = 7) or metformin (Arm B; n = 6) or pioglitazone (Arm C; n = 5) in addition to peginterferon alfa-2b (1.5 μg/kg/week) plus ribavirin (1000-1200 mg/day) or just PR (Arm D; n = 5). The primary end point was SVR, and secondary end points were viral clearance at Weeks 17, 29, and 53. There were no differences among all arms at baseline.
  
  
  RESULTS
  Using intent-to-treat analysis, SVR was observed in 66.7% (4/6), 83.3% (5/6), 66.7% (4/6), and 60% (3/5) in Arms A, B, C, and D, respectively. SVR was higher in female patients receiving OHA [90% (9/10)] than in male patients [50% (4/8)]. Results of per protocol analysis showed that SVR was 80.0% (4/5) in Arm A, 100% (5/5) in Arm B, 66.7% (4/6) in Arm C, and 60% (3/5) in Arm D. Patients receiving OHA had a higher rapid virologic response: 11/18 (61%) versus 2/5 (40%). Complete early virologic response was comparable between patients receiving OHA and PR [15/18 (83%) vs. 4/5 (80%)].
  
  
  CONCLUSIONS
  Our preliminary data show add-on OHAs to PR might achieve better early viral kinetics and SVR. However, further larger studies are needed to confirm these findings.
authors: Division of Gastroenterology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan; School of Medicine, College of Medicine, Tzu Chi University, Hualien, Taiwan.
authors: Ching-Sheng
authors: CS
authors: Hsu
authors: Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou City, Yun-Lin County, Taiwan.
authors: Shih-Jer
authors: SJ
authors: Hsu
authors: Division of Gastroenterology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan; School of Medicine, College of Medicine, Tzu Chi University, Hualien, Taiwan.
authors: Hans Hsienhong
authors: HH
authors: Lin
authors: Division of Gastroenterology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan; School of Medicine, College of Medicine, Tzu Chi University, Hualien, Taiwan.
authors: Tai-Chung
authors: TC
authors: Tseng
authors: Division of Gastroenterology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan; School of Medicine, College of Medicine, Tzu Chi University, Hualien, Taiwan.
authors: Chia-Chi
authors: CC
authors: Wang
authors: Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Genomics Research Center, Academia Sinica, Nankang, Taiwan.
authors: Ding-Shinn
authors: DS
authors: Chen
authors: Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: kaojh@ntu.edu.tw.
authors: Jia-Horng
authors: JH
authors: Kao
mesh_terms: D020909:Acarbose / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D024921:Drug Resistance, Multiple, Viral / Q000187:drug effects*; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007333:Insulin Resistance; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D010865:Pilot Projects; D000077205:Pioglitazone; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D012737:Sex Factors; D045162:Thiazolidinediones / Q000627:therapeutic use; D019562:Viral Load / Q000187:drug effects*
chemical_list: D000998:Antiviral Agents; D007004:Hypoglycemic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D045162:Thiazolidinediones; D011092:Polyethylene Glycols; D012254:Ribavirin; D008687:Metformin; C417083:peginterferon alfa-2b; D020909:Acarbose; D000077205:Pioglitazone
keywords: hepatitis C virus; insulin resistance; oral hypoglycemic agents; pegylated interferon; randomized controlled trial; sustained virological response