T.
Bader from the Veterans Administration Medical Center in Oklahoma City and colleagues
conducted a study to assess the safety and antiviral activity of fluvastatin (Lescol)
in chronic hepatitis C patients.
The 2006 in vitro study mentioned above
found that fluvastatin had the strongest anti-HCV activity of all the tested drugs
in its class. In Bader's previous analysis - which looked at treatment response
rates in individuals undergoing hepatitis C therapy who also happened to be taking
a statin - the one patient on fluvastatin achieved sustained virological response.
In
the present prospective study, 31 veterans with chronic hepatitis C were treated
with 20 to 230 mg/day oral fluvastatin as monotherapy for 2 to 12 weeks, and received
weekly monitoring of HCV RNA and liver function tests. HCV viral load levels were
compared with those of an untreated control group.
Results
•
11 of 22 patients (50%) who received 80 mg/day or less of fluvastatin experienced
a significant reduction in HCV RNA compared with the control group.
•
The first reduction in viral load occurred within 4 weeks of starting fluvastatin
in 9 of 11 patients (82%).
•
The largest weekly change in HCV RNA was a 1.75 log10 reduction.
•
Among responders, the reduction in viral load remained relatively constant for
2 to 5 weeks in 7 of 9 patients (78%).
•
However, in 2 subjects HCV RNA rebounded on the next test to a non-significant
change from baseline.
•
Continued viral load reduction was seen in 2 of 19 patients (22 %) patients at
the end of the study.
•
There was no evidence of worsening liver function.
Conclusion
"Fluvastatin
used as monotherapy in vivo showed suppressive effects [on] HCV clinically that
are modest, variable, and often short-lived," the study authors concluded.
They noted that these findings offer a "proof-of-concept" for
pilot trials combining fluvastatin with standard interferon-based
therapy for chronic hepatitis C. "Statins, and fluvastatin in particular,
appear to be safe for use in [patients with] hepatitis C," they added.
4/22/08
Reference T
Bader, J Fazili, M Madhoun, and others. Fluvastatin Inhibits Hepatitis C Replication
in Humans. American Journal of Gastroenterology. April 9, 2008 [Epub ahead
of print].
FDA-approved
Treatments
Results
