A new study has demonstrated the potential of statins, used in important cholesterol management therapies, for improving the management of hepatitis C .
Statins or HMG-CoA reductase inhibitors form a class of hypolipidemic agents, used as pharmaceutical agents to lower cholesterol levels in people with or at risk for cardiovascular disease.
Two studies were conducted by a team of researchers led by Ted Bader at the University of Oklahoma in Oklahoma City to see the effect of statins.
As part of the first study, researchers conducted a 14-day study looking at the antiviral effect of fluvastatin (FLV) in vivo, in hepatitis C virus (HCV) patients who take statins, to see whether they experience any improvements in alanine transaminase (ALT, liver enzymes) levels.
The researchers reported the total bilirubin (TB, yellow breakdown product) and ALT results and compared the findings to an existing hepatitis C registry data.
Researchers found that three patients with abnormal ALTs at baseline experienced significant improvement and nine patients who started with normal ALTs stayed normal.
In addition, there were no significant changes in TB levels. No liver problems were noted despite FLV doses that were up to four times the highest FDA-approved dose.
Scientists also examined the existing HCV registry and noted both the number of patients who improved their abnormal ALT levels after statin therapy and the number of patients who maintained their normal ALT levels after initiation of statin therapy. Of the abnormal ALT group, 12 had improved ALT and one stayed unchanged. Of the 47 beginning in the normal range, 45 maintained their ALTs.
"This is the first report of prospectively using fluvastatin in HCV patients. Two remarkable observations were made and data not only supports the lack of harm in this situation, but also seems to suggest a possible salutary effect t
hat needs further study," Bader said.
As part of naother study researchers retrospectively analyzed the effect of taking peginterferon and ribavirin (PI+R, hepatitis C treatment options) and PI+R plus a statin to measure the sustained viral response (SVR, negative virus in blood six months after the end of treatment) rate in hepatitis C patients.
In this study, 104 patients taking PI+R were compared to 30 patients who took PI+R plus a statin. Almost all patients (25 of the 30) taking a statin were on simvastatin, two were on lovastatin, two were on atorvastatin and one on fluvastatin.
Researchers found that the patients on standard treatment achieved a 37 percent SVR rate, the highest SVR reported to date in the medical literature for a VA-based population.
Having a high SVR rate means a cure is 95 percent of the time based upon long-term follow up that is greater than six months after treatment. The SVR rate for patients taking triple therapy, PI+R plus a statin, was 63 percent.
"It is important for statins to be studied prospectively for their effect on hepatitis C. Further study may contribute to developing a more effective outcome of treatment," Bader said.
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