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Omega-3 fatty acids and/or fluvastatin in hepatitis C prior non-responders to combination antiviral therapy - a pilot randomised clinical trial

Lookup NU author(s): Dr David Sheridan, Dr Simon Bridge, Dr Daniel Felmlee, Fiona Fenwick, Dr R Neely, Emeritus Professor Margaret Bassendine

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Abstract

AbstractBackground & AimsHepatitis 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((R)) 40-80mg) and n-3 PUFA (Omacor((R))1g and 2-4g) on HCV-RNA and lipoviral particles (LVP) in difficult to treat prior non-responders.MethodsPatients (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 12weeks 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.Results35% 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. 12weeks of low-dose n-3 PUFA decreased median IP10 concentration by -39pg/ml (-111, 7.0pg/ml Q1-Q3).ConclusionsFluvastatin 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.

Publication metadata

Author(s): Sheridan DA, Bridge SH, Crossey MME, Felmlee DJ, Fenwick FI, Thomas HC, Neely RDG, Taylor-Robinson SD, Bassendine MF

Publication type: Article

Publication status: Published

Journal: Liver International

Year: 2014

Volume: 34

Issue: 5

Pages: 737-747

Print publication date: 01/05/2014

Online publication date: 14/10/2013

Acceptance date: 29/08/2013

ISSN (print): 1478-3223

ISSN (electronic): 1478-3231

Publisher: Wiley-Blackwell

URL: http://dx.doi.org/10.1111/liv.12316

DOI: 10.1111/liv.12316

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