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Published on: October 1, 2015
Fluvastatin inhibits hepatitis C replication in humans
Ted Bader1, Javid Fazili, Mohammed Madhoun
1Veteran's Administration Medical Center, Oklahoma City, OK 73104, USA.
Insights
Fluvastatin showed modest, short-lived antiviral effects in chronic hepatitis C (HCV) patients. This study supports further research into fluvastatin combined with standard HCV therapies, indicating statins are safe for hepatitis C treatment.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Hepatitis C viral (HCV) infection is a leading cause of liver disease deaths in the US.
- Current treatments achieve sustained viral remission in only 50% of patients.
- Fluvastatin exhibits in vitro antiviral activity against HCV.
Purpose of the Study:
- To evaluate the safety and antiviral efficacy of fluvastatin in individuals with chronic HCV.
- To determine the impact of fluvastatin on HCV RNA levels and liver function tests.
Main Methods:
- A prospective study involving 31 veterans with chronic HCV.
- Oral fluvastatin doses ranged from 20 to 320 mg/day for 2-12 weeks.
- Weekly monitoring of HCV RNA and liver function tests.
Main Results:
- 50% of patients (11/22) on 80 mg/day or less showed reduced HCV RNA.
- Viral load reduction was observed within 4 weeks in 82% of responders.
- The antiviral effect was often transient, with viral load rebound in some patients.
Conclusions:
- Fluvastatin monotherapy demonstrated modest, variable, and often short-lived in vivo suppression of HCV.
- Findings support the concept of combining fluvastatin with standard therapies for HCV.
- Fluvastatin and statins appear safe for use in patients with hepatitis C.
Unlabelled:
BACKGROUND Hepatitis C viral (HCV) infection is the leading cause of death due to liver disease in the United States. Currently, pegylated interferon and ribavirin produce sustained viral remission in only 50% of patients. Additional agents are needed to increase the cure rate. In vitro experiments show strong antiviral effects of fluvastatin against HCV.
Objectives:
To assess the safety and antiviral effects of fluvastatin in chronic HCV carriers.
Methods:
31 veterans with chronic HCV were prospectively given oral doses of fluvastatin, 20 to 320 mg/day, for 2-12 weeks with weekly monitoring of HCV RNA and liver tests. Reductions of viral load (P < 0.01) versus a control group were considered suppressive.
Results:
With 80 mg a day or less, 11/22 (50%) patients responded by lowering HCV RNA. The first lowering occurred within 4 weeks (9/11, 82%). The greatest weekly change in HCV RNA level was a 1.75 log(10) reduction. When lowered in responders, the viral load remained relatively constant for 2-5 weeks (7/9, 78%), or on the next test rebounded immediately to a non-significant change from, baseline (n = 2). Continued lowering of virus was seen in 2/19 (22 %) patients when the study ended. We found no evidence of liver tests worsening.
Conclusions:
FLV used as monotherapy in vivo showed suppressive effects of HCV clinically that are modest, variable, and often short-lived. 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.
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