Clinical trials registration: EudraCT 2006–004335–29.
Omega-3 fatty acids and/or fluvastatin in hepatitis C prior non-responders to combination antiviral therapy – a pilot randomised clinical trial
Article first published online: 14 OCT 2013
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Volume 34, Issue 5, pages 737–747, May 2014
How to Cite
Liver Int. 2014: 34: 737–747
- Issue published online: 8 APR 2014
- Article first published online: 14 OCT 2013
- Accepted manuscript online: 11 SEP 2013 01:16AM EST
- Manuscript Accepted: 29 AUG 2013
- Manuscript Received: 3 NOV 2012
- Medical Research Council. Grant Number: G0502028
- hepatitis C virus;
- lipoviral particle;
- polyunsaturated fatty acid (omega-3 fatty acids)
Background & Aims
Hepatitis C virus (HCV) utilises cholesterol and lipoprotein metabolism for replication and infectivity. Statins and omega-3 (n–3) polyunsaturated fatty acids (PUFA) have been shown to have antiviral properties in vitro. This open label pilot study evaluated the efficacy of fluvastatin (Lescol® 40–80 mg) and n-3 PUFA (Omacor®1 g and 2–4 g) on HCV-RNA and lipoviral particles (LVP) in difficult to treat prior non-responders.
Patients (n = 60) were randomly allocated in a factorial design to: no active drug; low-dose n-3 PUFA; high-dose n-3 PUFA; fluvastatin; low-dose n-3 PUFA + fluvastatin; or high-dose n-3 PUFA + fluvastatin. 50/60 completed study drugs for 12 weeks and followed up to week 24. Comparison was made between fluvastatin (n = 24) vs no fluvastatin (n = 26) and n-3 PUFA high-dose (n = 17) vs low-dose (n = 17) vs none (n = 16). The primary outcomes were change in total HCV-RNA, LVP and ALT at week 12 compared with baseline. Secondary outcome was change in interferon-gamma-inducible protein-10 (IP10) as a measure of interferon activation.
35% had compensated cirrhosis and 45% were prior null responders. There was no significant change in total HCV RNA, LVP, non-LVP or LVP ratio in patients receiving fluvastatin or n-3 PUFAs. ALT was not significantly different in those treated with fluvastatin or n-3 PUFAs. 12 weeks of low-dose n-3 PUFA decreased median IP10 concentration by −39 pg/ml (−111, 7.0 pg/ml Q1–Q3).
Fluvastatin and n-3 PUFAs have no effect on plasma HCV-RNA or LVP. The effect of low-dose n-3 PUFA on IP10 warrants further prospective evaluation as a supplemental therapy to enhance interferon sensitivity.