title: Rosuvastatin reduces nonalcoholic fatty liver disease in patients with chronic hepatitis C treated with α-interferon and ribavirin: Rosuvastatin reduces NAFLD in HCV patients.
abstract: BACKGROUND
  Nonalcoholic fatty liver disease develops in patients with chronic hepatitis C. Interferon and ribavirin combination therapy is the standard treatment for chronic hepatitis C, but if present, NAFLD can reduce the virological response to anti-HCV therapies.
  
  
  OBJECTIVE
  We determined whether the addition of rosuvastatin to interferon and ribavirin improves the sustained virological response (SVR) and reduces steatosis.
  
  
  METHODS
  This study was a prospective, randomized, open-label trial. Between January 2004 and December 2007, 65 patients with chronic hepatitis (27 women and 38 men, mean age 48 years) aged 32-63 years (median 46 years) were consecutively enrolled. Patients were randomly assigned to receive leukocyte interferon alpha (3 MIU 3 times per week) plus ribavirin (1200 mg per day) for 12 months or interferon alpha and ribavirin at the same dosages plus rosuvastatin (5 mg per day). The primary endpoints were measurements in SVR, liver enzyme, cholesterol, triglyceride, CRP, glucose, and insulin levels; and Homa-IR, fibrosis, and steatosis scores.
  
  
  RESULTS
  After 12 months of treatment, we observed a significant improvement in SVR in 51% of patients who received interferon plus ribavirin plus rosuvastatin compared with 18% of relapsers (OR 1.52; 95% CI = 0.41-5.64; RR 1.13). There were 23 responders (69%) and 10 nonresponders (30%) (OR 1.38; 95% CI = 0.49-16.5; RR 1.11). When comparing interferon plus ribavirin group vs interferon plus ribavirin and rosuvastatin group after 12 months, we observed a significant difference in AST (85.70 vs.106.5.00 IU/ml) (OR 1.2; 95% CI= 0.29-4.94; RR 1.04; p<0.001), ALT (81.80 vs. 126.2 IU/ml) (OR 1.2; 95% CI = 0.29-4.94; RR 1.04; p < 0.001), LDL-cholesterol (0.01 vs. 0.60 mmol/l) (OR 14; 95% CI = 3.98-49.16; p RR 2.96; < 0.001), triglycerides (0.17 vs. 0.2 mmol/l) (OR 20; 95% CI = 4.94-80.89; RR 5.38; p < 0.05), and Viremia (1.8 vs. 2.48 UI/ml, p < 0.05). Mean fibrosis score decreased 0.10 vs. 0.50 (OR 4.5; 95% CI = 0.89-22.66; RR 1.5; p < 0.05), and mean steatosis score declined 0.30 vs. 0.50 (OR 11.2; CI = 2.88-43.53; RR 2.75; p < 0.001).
  
  
  CONCLUSIONS
  In HCV patients with NAFLD, the addition of rosuvastatin to interferon and ribavirin significantly reduces viremia, steatosis, and fibrosis without causing side effects.
authors.affiliation: Department of Biochemistry, Medical Chemistry and Molecular Biology, University of Catania, Catania, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Malaguarnera
authors.forename: Marco
authors.initials: M
authors.lastname: Vacante
authors.forename: Cristina
authors.initials: C
authors.lastname: Russo
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Gargante
authors.forename: Maria
authors.initials: M
authors.lastname: Giordano
authors.forename: Gaetano
authors.initials: G
authors.lastname: Bertino
authors.forename: Sergio
authors.initials: S
authors.lastname: Neri
authors.forename: Mariano
authors.initials: M
authors.lastname: Malaguarnera
authors.forename: Fabio
authors.initials: F
authors.lastname: Galvano
authors.forename: Giovanni
authors.initials: G
authors.lastname: Li Volti
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