Statin Boosts Response to Pegylated Interferon/Ribavirin
A number of studies -- both laboratory analyses and observation studies in
which hepatitis C patients happened to be taking statins for other reasons
-- have suggested that statins, also known as HMG-CoA reductase inhibitors,
can inhibit hepatitis C virus (HCV) replication and therefore might be a
useful addition to interferon-based therapy.
As reported at the European Association for the Study of the Liver's
International Liver Congress (EASL 2011) this week in Berlin, Romanian
researchers conducted a double-blind pilot study to assess the effects of
fluvastatin -- the statin that appears to have the most potent anti-HCV
activity -- on virological response to standard hepatitis C treatment.
The study included more than 200 previously untreated chronic hepatitis C
patients with hard-to-treat HCV genotype 1. People who had taken statins
within the year prior to the start of the study were excluded.
In addition to using a standard regimen of pegylated interferon plus
ribavirin for 48 weeks, participants were randomly assigned to receive
either a normal therapeutic dose of fluvastatin (20 mg once-daily) or
placebo for 72 weeks -- that is, through the end of the 24 week
post-treatment follow-up period for determining sustained virological
response (SVR). The randomly chosen patients received the statin
irrespective of their lipid profiles.
At week 12 of treatment, patients taking fluvastatin were significantly
more likely to achieve early virological response (EVR) than placebo
recipients, 76% vs 62%, respectively (odds ratio 1.94, or about twice as
The same effect was observed for SVR, with rates of 63% vs 49%,
respectively (odds ratio 1.77).
In an analysis that excluded participants with metabolic syndrome (about
one-quarter of the study population), early and sustained response rates
remained higher in the fluvastatin arm (EVR 85% vs 71%; SVR 74% vs 58%).
Fluvastatin recipients experienced larger percentage decreases in HCV viral
There were no significant differences, however, in ALT levels between the 2
"Fluvastatin showed a significant, albeit modest improvement in terms of EVR
and SVR in chronic hepatitis C [patients] treated with standard [pegylated
interferon/ribavirin] therapy," the investigators concluded.
"This synergistic effect with interferon, driven perhaps through the
inhibition of geranylgeranylation of cellular proteins," they hypothesized,
suggests that "lipid-lowering agents might favor HCV clearance and can be
useful in chronic hepatitis C treatment, irrespective the presence of
Investigator affiliations: Internal Medicine/Gastroenterology, Filantropia
Municipal Hospital, Craiova, Romani;a Internal Medicine, University of
Medicine and Pharmacy Craiova, Craiova, Romania Internal Medicine,
Morphopathology, and Endocrinology, Filantropia Municipal Hospital, Craiova,
EF Georgescu, L Streba, R Teodorescu, et al. Potential enhancement of both
early (EVR) and sustained (SVR) virological response by fluvastatin in
chronic hepatitis C treated with standard PegIFN-ribavirin therapy. A pilot
study. 46th Annual Meeting of the European Association for the Study of the
Liver (EASL 2011). Berlin. March 30-April 3. Abstract 198.