title: Effect of fluvastatin on 24-week telaprevir-based combination therapy for hepatitis C virus genotype 1b-infected chronic hepatitis C.
abstract: OBJECTIVE
  The addition of fluvastatin significantly improves sustained virological response (SVR) in pegylated interferon and ribavirin (peg-IFN/RBV) combination therapy for patients infected with the hepatitis C virus. However, the add-on effect on telaprevir-based triple combination therapy remains unknown. The aim of this study was to investigate the effect of fluvastatin on telaprevir-based combination therapy by conducting a prospective, open-label, randomized, controlled trial.
  
  
  METHODS
  Among 124 genotype 1b-infected chronic hepatitis C patients recruited, 116 eligible patients were allocated randomly to two study arms; they received 12 weeks of telaprevir/peg-IFN/RBV, followed by 12 weeks of peg-IFN/RBV with or without 24 weeks of fluvastatin (fluvastatin group and control group, respectively). Treatment outcomes and adverse effects were compared between the two groups.
  
  
  RESULTS
  There were 56 men and 60 women, median age 60 years (range, 28-71 years). Rapid virological response and end of treatment response rates were 87.9% (51/58) and 96.6% (56/58) in the control group and 75.9% (44/58) and 98.3% (57/58) in the fluvastatin group, respectively. SVR rates in the control group and the fluvastatin group were 84.5% (49/58) and 81.0% (47/58), respectively; there was no significant difference (P=0.806). Stratified analysis showed that no factors associated with the SVR rate were found between the two groups. No adverse events were associated with fluvastatin.
  
  
  CONCLUSIONS
  In this trial, administration of fluvastatin with telaprevir/peg-IFN/RBV was a safe combination. However, fluvastatin had no add-on effect on 24-week telaprevir-based combination therapy for chronic hepatitis C genotype 1b-infected patients.
authors.affiliation: aDepartment of Internal Medicine, Division of Gastroenterology, Nippon Medical School Chiba Hokusoh Hospital, Inzai bInstitute of Clinical Medicine and Research (ICMR), Jikei University School of Medicine, Kashiwa cDivision of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Matsudo, Chiba dDepartment of Internal Medicine, Division of Gastroenterology and Hepatology eDepartment of Internal Medicine, Division of Hematology, Nippon Medical School, Bunkyo-ku fDepartment of Internal Medicine, Division of Gastroenterology, Hakujikai Memorial Hospital, Adachi-ku, Tokyo, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Atsukawa
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsubota
authors.forename: Noritomo
authors.initials: N
authors.lastname: Shimada
authors.forename: Chisa
authors.initials: C
authors.lastname: Kondo
authors.forename: Norio
authors.initials: N
authors.lastname: Itokawa
authors.forename: Ai
authors.initials: A
authors.lastname: Nakagawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Fukuda
authors.forename: Yoko
authors.initials: Y
authors.lastname: Matsushita
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Narahara
authors.forename: Yuji
authors.initials: Y
authors.lastname: Osada
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yamaguchi
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Nakatsuka
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Iwakiri
authors.forename: Chiaki
authors.initials: C
authors.lastname: Kawamoto
authors.forename: Choitsu
authors.initials: C
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000077340:Fluvastatin; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D000998:Antiviral Agents; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D009842:Oligopeptides; D000077340:Fluvastatin; C486464:telaprevir