Researchers have yet to report on the concept that hepatitis C virus (HCV) patients who take statins may experience improvements in alanine transaminase (ALT, liver enzymes) levels.
Use of statins for hepatitis C has not occurred in the past as the FDA-approved package insert for every statin lists “active liver disease” as a contraindication for use and hepatitis C would certainly qualify as an active liver disease.
In such a setting, a researcher must request a special license form from the FDA called an investigational new drug (IND) license. As part of an IRB and FDA-approved 14-day study looking at the antiviral effect of fluvastatin (FLV) in vivo, researchers reported the total bilirubin (TB, yellow breakdown product) and ALT results and compared the findings to an existing hepatitis C registry data.
Initial results showed 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.
Experts 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 (13 of 60 pts), 12 had improved ALT and one stayed unchanged. Of the 47 beginning in the normal range, 45 maintained their ALTs. The remaining two who developed a mildly abnormal ALT after beginning a statin were noted as suffering from heavy alcohol abuse, suggesting an unrelated cause for the change.
“This is the first report of prospectively using fluvastatin in HCV patients,” says Ted Bader, M.D., of University of Oklahoma in Oklahoma City, Okla., and lead author of this study. “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 that needs further study.”