title: Combination of fluvastatin with pegylated interferon/ribavirin therapy reduces viral relapse in chronic hepatitis C infected with HCV genotype 1b.
abstract: OBJECTIVE
  Although the anti-hepatitis C virus (HCV) effect of statins in vitro and clinical efficacy of fluvastatin combined with Pegylated interferon (PEG-IFN)/ribavirin therapy for chronic hepatitis C (CHC) have been reported, the details of clinical presentation are largely unknown. We focused on viral relapse that influences treatment outcome, and performed a post-hoc analysis by using data from a randomized controlled trial.
  
  
  METHODS
  Thirty-four patients in the fluvastatin group and 33 patients in the non-fluvastatin group who achieved virological response (complete early virological response [cEVR] or late virological response [LVR]) with PEG-IFN/ribavirin therapy were subjected to this analysis. Factors contributing to viral relapse were identified by using multiple logistic regression analysis.
  
  
  RESULTS
  Relapse rate in patients with cEVR was significantly lower in the fluvastatin group (2 of 23, 8.7%) than in the non-fluvastatin group (9 of 26, 34.6%; P = 0.042). The use of fluvastatin decreased relapse rate in patients with LVR (27.3% vs 57.1%), though not significantly. Overall, relapse rate was significantly lower in the fluvastatin group (14.7%; 5 of 34) than in the non-fluvastatin group (39.4%; 13 of 33; P = 0.027). Multivariate analysis identified absence of fluvastatin (P = 0.027, odds ratio [OR] = 3.98, 95% confidence interval [CI] = 1.05-15.11) and low total ribavirin dose (P = 0.002, OR = 2.41, 95% CI = 1.38-4.19) as independent factors contributing to relapse.
  
  
  CONCLUSIONS
  The concomitant addition of fluvastatin significantly suppressed viral relapse, resulting in the improvement of sustained virological response rate, in PEG-IFN/ribavirin therapy for CHC patients with HCV genotype 1b and high viral load.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Chiba, Japan. momogachi@yahoo.co.jp
authors.forename: Masanori
authors.initials: M
authors.lastname: Atsukawa
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsubota
authors.forename: Chisa
authors.initials: C
authors.lastname: Kondo
authors.forename: Norio
authors.initials: N
authors.lastname: Itokawa
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Narahara
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Nakatsuka
authors.forename: Satomi
authors.initials: S
authors.lastname: Hashimoto
authors.forename: Takeshi
authors.initials: T
authors.lastname: Fukuda
authors.forename: Yoko
authors.initials: Y
authors.lastname: Matsushita
authors.forename: Hideko
authors.initials: H
authors.lastname: Kidokoro
authors.forename: Tamaki
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Hidenori
authors.initials: H
authors.lastname: Kanazawa
authors.forename: Choitsu
authors.initials: C
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D016001:Confidence Intervals; D004359:Drug Therapy, Combination; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D007211:Indoles / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011092:Polyethylene Glycols / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000077340:Fluvastatin; C417083:peginterferon alfa-2b