05/06/08

UNITED STATES:  Fluvastatin Inhibits Hepatitis C Replication in Humans

The researchers noted the strong demand for additional treatments to increase the cure rate of hepatitis C virus (HCV) infection. At present, pegylated interferon and ribavirin produce sustained viral remission in only 50 percent of patients. HCV is the leading cause of death by liver disease in the United States.

Experiments in vitro have shown that fluvastatin has strong antiviral effects against HCV. The authors designed the present study to assess the safety and antiviral effects of fluvastatin in chronic HCV patients.

At the Veteran's Administration Medical Center in Oklahoma City, Okla., 31 veterans with chronic HCV were prospectively given oral doses of fluvastatin: 20 to 320 mg per day for two to 12 weeks. The patients were monitored by HCV RNA and liver tests. Reductions of viral load (P<0.01) compared to a control group were considered suppressive.

Among patients receiving 80 mg a day or less, 11 of 22 (50 percent) achieved lower HCV RNA. The first lowering occurred within four weeks (9 of 11 patients, 82 percent). The greatest weekly change in HCV RNA was a 1.75 log10 reduction. When lowered in responders, the viral load remained relatively constant for two to five weeks (7 of 9 patients, 78 percent), or at the next test rebounded immediately to a non-significant change from baseline (n=2). In 2 of 19 patients (22 percent), continued lowering of the virus was noted when the study ended. The authors found no evidence of worsening liver tests.

Used as monotherapy in vivo, fluvastatin "showed suppressive effects of HCV clinically that are modest, variable, and often short-lived," the researchers concluded. "These findings support 'proof-of-concept' for pilot trials combining fluvastatin with standard therapy. Statins and fluvastatin, in particular, appear to be safe for use in hepatitis C."

Source: American Journal of Gastroenterology Vol. 103: P. 1-3 (04..08):: Ted Bader, MD; Javid Fazili, MD; Mohammed Madhoun, MD; Christopher Aston, PhD; Diane Hughes, NP; Syed Rizvi, MD; Ken Seres, MD; Muhammad Hasan, MD ; Courtesy of the CDC National Center for HIV, STD, and TB Prevention