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

Sheridan, David, Bridge, Simon, Crossey, Mary, Felmlee, Daniel, Fenwick, Fiona, Thomas, Howard, Neely, Robert Dermot, Taylor-Robinson, Simon and Bassendine, Margaret (2013) Omega-3 fatty acids and/or fluvastatin in hepatitis C prior non-responders to combination anti-viral therapy - a pilot randomised clinical trial. Liver International, 34 (5). pp. 737-747. ISSN 1478-3223

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Abstract

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.

Methods
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.

Results
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).

Conclusions
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.

Item Type:	Article
Additional Information:	Published online before print.
Uncontrolled Keywords:	cholesterol, fluvastatin, hepatitis C virus, interferon-α, lipoviral particle, polyunsaturated fatty acid (omega-3 fatty acids)
Subjects:	B200 Pharmacology, Toxicology and Pharmacy B900 Others in Subjects allied to Medicine
Department:	Faculties > Health and Life Sciences > Applied Sciences
Depositing User:	Ay Okpokam
Date Deposited:	09 Oct 2013 10:42
Last Modified:	12 Oct 2019 18:27
URI:	http://nrl.northumbria.ac.uk/id/eprint/13846

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