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

David A. Sheridan; Simon H. Bridge; Mary M.E. Crossey; Daniel J. Felmlee; Fiona I. Fenwick; Howard C. Thomas; R. Dermot G. Neely; SD Taylor‐Robinson; Margaret F. Bassendine

doi:10.1111/liv.12316

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

David A. Sheridan^*, Simon H. Bridge, Mary M.E. Crossey, Daniel J. Felmlee, Fiona I. Fenwick, Howard C. Thomas, R. Dermot G. Neely, SD Taylor‐Robinson, Margaret F. Bassendine

^*Corresponding author for this work

Peninsula Medical School

Research output: Contribution to journal › Article › peer-review

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® 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.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 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.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. 12 weeks of low‐dose n‐3 PUFA decreased median IP10 concentration by −39 pg/ml (−111, 7.0 pg/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.

Original language	English
Pages (from-to)	737-747
Number of pages	0
Journal	Liver International
Volume	34
Issue number	5
Early online date	14 Oct 2013
DOIs	https://doi.org/10.1111/liv.12316
Publication status	Published - May 2014

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Sheridan, D. A., Bridge, S. H., Crossey, M. M. E., Felmlee, D. J., Fenwick, F. I., Thomas, H. C., Neely, R. D. G., Taylor‐Robinson, SD., & Bassendine, M. F. (2014). Omega‐3 fatty acids and/or fluvastatin in hepatitis C prior non‐responders to combination antiviral therapy – a pilot randomised clinical trial. Liver International, 34(5), 737-747. https://doi.org/10.1111/liv.12316

@article{9144282d2fed41eea0d513cf2c3a9c90,

title = "Omega‐3 fatty acids and/or fluvastatin in hepatitis C prior non‐responders to combination antiviral therapy – a pilot randomised clinical trial",

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{\textregistered} 40–80 mg) and n‐3 PUFA (Omacor{\textregistered}1 g and 2–4 g) 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 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.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. 12 weeks of low‐dose n‐3 PUFA decreased median IP10 concentration by −39 pg/ml (−111, 7.0 pg/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.",

author = "Sheridan, {David A.} and Bridge, {Simon H.} and Crossey, {Mary M.E.} and Felmlee, {Daniel J.} and Fenwick, {Fiona I.} and Thomas, {Howard C.} and Neely, {R. Dermot G.} and SD Taylor‐Robinson and Bassendine, {Margaret F.}",

year = "2014",

month = may,

doi = "10.1111/liv.12316",

language = "English",

volume = "34",

pages = "737--747",

journal = "Liver International",

issn = "1478-3223",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "5",

}

Sheridan, DA, Bridge, SH, Crossey, MME, Felmlee, DJ, Fenwick, FI, Thomas, HC, Neely, RDG, Taylor‐Robinson, SD & Bassendine, MF 2014, 'Omega‐3 fatty acids and/or fluvastatin in hepatitis C prior non‐responders to combination antiviral therapy – a pilot randomised clinical trial', Liver International, vol. 34, no. 5, pp. 737-747. https://doi.org/10.1111/liv.12316

TY - JOUR

T1 - Omega‐3 fatty acids and/or fluvastatin in hepatitis C prior non‐responders to combination antiviral therapy – a pilot randomised clinical trial

AU - Sheridan, David A.

AU - Bridge, Simon H.

AU - Crossey, Mary M.E.

AU - Felmlee, Daniel J.

AU - Fenwick, Fiona I.

AU - Thomas, Howard C.

AU - Neely, R. Dermot G.

AU - Taylor‐Robinson, SD

AU - Bassendine, Margaret F.

PY - 2014/5

Y1 - 2014/5

N2 - 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® 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.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 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.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. 12 weeks of low‐dose n‐3 PUFA decreased median IP10 concentration by −39 pg/ml (−111, 7.0 pg/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.

AB - 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® 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.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 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.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. 12 weeks of low‐dose n‐3 PUFA decreased median IP10 concentration by −39 pg/ml (−111, 7.0 pg/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.

U2 - 10.1111/liv.12316

DO - 10.1111/liv.12316

M3 - Article

SN - 1478-3223

VL - 34

SP - 737

EP - 747

JO - Liver International

JF - Liver International

IS - 5

ER -

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

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