Statins
Improve Sustained Response to Interferon-based Therapy in Small Study By
Liz Highleyman Last
summer, M. Ikeda and colleagues garnered headlines with the news that certain
HMG-CoA reductase inhibitors -- better known as statins -- inhibited hepatitis
C virus (HCV) replication in cell culture model, especially when combined
with interferon.
However,
a recently published pilot study by J. O'Leary and colleagues found that atorvastatin
(Lipitor) did not reduce HCV RNA levels in untreated hepatitis C patients
who happened to be taking normal doses of the drug (20 mg daily) to manage high
cholesterol.
In
contrast, a study presented at the Digestive Disease Week
conference (DDW 2007) this week in Washington, DC, suggested that statins
may indeed further inhibit HCV replication in patients who are receiving treatment
with pegylated interferon plus ribavirin. T.
Bader and colleagues from the Veterans Administration Medical Center in Oklahoma
City studied 134 patients taking pegylated
interferon/ribavirin, 30 of whom by chance were also taking a statin. Most
(25) were on simvastatin (Zocor), 2 were on lovastatin (Mevacor), 2 on atorvastatin
(Lipitor), and 1 on fluvastatin (Lescol). The
researchers used a modified intent-to-treat approach, whereby all patients who
had a least 1 data point after starting therapy were included in the analysis.
To derive a pooled rate, they assumed 70% with genotype 1 and 30% with non-1 genotypes,
reflecting the proportion of these genotypes in the U.S. population. Results •
The pooled sustained virological response
(SVR) rate for the 104 patients on pegylated interferon/ribavirin without
a statin was 37% (the highest ever reported for a VA-based population).
•
The pooled SVR rate
for the group taking pegylated interferon/ribavirin plus a statin was 63%.
•
The effect was statistically
strongest for patients with genotype 1 HCV (SVR 25% without statins vs 55% with
statins).
•
For genotype 2 patients,
SVR rates were 60% without and 77% with statins.
•
For genotype 3 patients,
SVR rates were 47% without and 100% with statins.
Conclusion "Statins
appear to be associated with a higher SVR rate [compared with] standard pegylated
interferon + ribavirin therapy," the investigators concluded.
They
noted that this observation occurred among patients who were mostly using a "medium-powered"
statin in terms of Ikeda's study. The sole patient taking fluvastatin was cured.
(Ikeda and colleagues found that fluvastatin demonstrated the strongest anti-HCV
activity, atorvastatin and simvastatin showed moderate activity, lovastatin exhibited
the weakest activity, and pravastatin [Pravachol] had no anti-HCV activity.)
"Statins
need to be studied prospectively for their effect on hepatitis C and the outcome
of treatment," they added. 05/25/07 References
T Bader, M Madhoun, and S Rizvi. Retrospective Analysis of
the Effect of Taking a Statin Along with Peginterferon and Ribavirin (PI+R) on
SVR. Digestive Disease Week 2007 (DDW 2007). Washington, DC. May 19-24, 2007.
Abstract M1845.
M Ikeda, A Ken-ichi, M Yamada, and others. Different Anti-HCV
Profiles of Statins and Their Potential for Combination Therapy with Interferon.
Hepatology 44(1): 117-125. July 2006. JG
O'Leary, JL Chan, CM McMahon, and others. Atorvastatin does not exhibit antiviral
activity against HCV at conventional doses: A pilot clinical trial. Hepatology
45(4): 895-898. April 2007. <----
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