Clinical

Fluvastatin inhibits hepatitis C virus replication

Last Updated: 2008-07-07 14:45:20 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Fluvastatin inhibits hepatitis C virus (HCV) RNA replication in patients with chronic hepatitis C, according to a report in the June American Journal of Gastroenterology.

Fluvastatin, but not all statins, markedly suppresses HCV in vitro, the authors explain, but the drug has not been evaluated as a treatment for chronic hepatitis C.

In 31 veterans with chronic HCV infection, Dr. Ted Bader at the Veteran's Administration Medical Center in Oklahoma City, Oklahoma and colleagues evaluated the safety of fluvastatin and also monitored HCV viral load changes during fluvastatin monotherapy.

First, the researchers tested four oral doses of the extended-release formula of the drug (80, 160, 240, or 320 mg, given daily for 14 days), with 3 patients at each dose level. In this experiment, 2 of 3 patients taking 80 mg had a significant reduction in viral load, the authors report, and all patients treated with 80 mg, 160 mg, 240 mg, or 320 mg fluvastatin experienced improvements in ALT.

Then, because there seemed to be no added benefit to the higher doses, the researchers designed a second study in which patients received no more than 80 mg per day of fluvastatin. In this study, 11 of 22 patients responded with HCV RNA reductions. In 9 patients, HCV RNA levels fell within 4 weeks. In one patient, the response didn't occur until 12 weeks.

Once lowered, the HCV RNA value remained relatively constant in most patients for 2 to 5 weeks, but in some patients, it rebounded immediately to baseline. In only 2 of 19 patients did the viral load remain suppressed after fluvastatin was stopped.

Only one adverse reaction, nausea and diarrhea in a patient taking 320 mg fluvastatin for 5 days, was judged as possibly attributable to fluvastatin, the investigators say.

"Fluvastatin used as monotherapy in vivo showed suppressive effects on HCV clinically that are modest, variable, and often short-lived," the authors conclude. "These findings, along with other data suggesting synergism with alpha-interferon, support 'proof-of-concept' for trials combining fluvastatin with standard pegylated interferon plus ribavirin."

In a related editorial, Drs. Dawn M. Torres and Stephen A. Harrison from Brooke Army Medical Center, Fort Sam Houston, Texas write: "Treatment of chronic hepatitis C patients with statin monotherapy may transiently decrease viral loads, but does not result in viral eradication. Combination therapy with pegylated interferon, ribavirin, and statins may offer a synergistic effect...that ultimately may improve the sustained virological response."

"However," they caution, "prospective, randomized trials...are needed before we can call statin therapy an adjuvant treatment panacea."

Am J Gastroenterol 2008;103:1383-1389,1390-1392.