Boosts Response to Pegylated Interferon/Ribavirin
Fluvastatin, a drug typically used to manage high cholesterol,
improved early and sustained virological response rates
among chronic hepatitis C patients taking pegylated interferon
plus ribavirin, according to a report at EASL 2011.
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
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.
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 likely).
same effect was observed for SVR, with rates of 63% vs 49%,
respectively (odds ratio 1.77).
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%).
recipients experienced larger percentage decreases in HCV
were no significant differences, however, in ALT levels
between the 2 arms.
"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 metabolic syndrome."
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, Romania
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