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Updated: Sep 29, 2026

Immunofluorescence to Monitor the Cellular Uptake of Human Lactoferrin and its Associated Antiviral Activity Against the Hepatitis C Virus
Published on: October 1, 2015
Dose-response trial of lactoferrin in patients with chronic hepatitis C
Shuichi Okada1, Katsuaki Tanaka, Tosiya Sato
1Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo 104-0045, Japan. sokada@ncc.go.jp
Insights
Bovine lactoferrin (bLF) showed good tolerance in chronic hepatitis C (CH-C) patients but did not significantly alter viral RNA or ALT levels. Further large-scale trials are needed to confirm its potential anti-HCV activity.
Area of Science:
- Hepatology
- Virology
- Immunology
Background:
- Chronic hepatitis C (CH-C) is a significant global health issue.
- Current interferon-based treatments for CH-C have limited efficacy.
- Lactoferrin (LF), an iron-binding glycoprotein, exhibits antiviral properties and has shown potential against HCV in vitro.
Purpose of the Study:
- To evaluate the dose-response relationship of bovine lactoferrin (bLF) in patients with CH-C.
- To assess the impact of bLF on serum alanine aminotransaminase (ALT) and HCV RNA levels.
- To determine the safety and tolerability of bLF treatment in CH-C patients.
Main Methods:
- A trial involving 45 patients with CH-C, randomized into three groups receiving different oral doses of bLF (1.8, 3.6, or 7.2 g/day) for 8 weeks.
- Monitoring of serum ALT levels and quantitative HCV RNA levels throughout the treatment and follow-up period.
- Assessment of biochemical and virological responses, defined as a ≥50% decrease in ALT or HCV RNA levels, respectively.
Main Results:
- No significant correlation was found between bLF dosage and changes in serum ALT or HCV RNA levels.
- Limited biochemical and virological responses were observed in a small number of patients, with all responders relapsing post-treatment.
- Bovine lactoferrin was generally well-tolerated, with no serious adverse events reported.
Conclusions:
- Bovine lactoferrin demonstrates excellent tolerability in CH-C patients.
- The study suggests potential, albeit limited, anti-HCV activity warranting further investigation.
- Larger, randomized controlled trials are necessary to definitively establish the efficacy of bLF for CH-C treatment.
Abstract:
Hepatitis C virus (HCV) is one of the most common causes of chronic hepatitis. Interferon is presently the only effective treatment for chronic hepatitis C (CH-C), though its effectiveness is limited. Lactoferrin (LF), which is an 80-kDa, iron-binding glycoprotein, has several biological activities including anti-viral activity, and it was recently reported to inhibit HCV infection in cultured human hepatocytes. The present trial was designed to assess the relationship between the dose of bovine LF (bLF) and the effect of bLF on serum alanine aminotransaminase (ALT) and HCV RNA levels in patients with CH-C. Forty-five patients entered at each of the three dose levels (bLF of 1.8, 3.6, and 7.2 g/day) received orally an 8-week course of bLF. There was no significant relation between the dose of bLF and the effect of bLF on serum ALT or HCV RNA levels. Biochemical (a 50% or greater decrease in the serum ALT level) and virological (a 50% or greater decrease in HCV RNA level) responses were observed in two and four patients, respectively, but all responders relapsed during the follow-up period after bLF treatment. The bLF treatment was generally well tolerated, and no patient had any serious adverse event. In conclusion, the excellent tolerance and potential anti-HCV activity of bLF shown in this trial suggest that further trials using a large number of patients are mandatory. We are currently conducting a double-blind randomized controlled trial comparing bLF with placebo to clarify the anti-HCV activity of bLF in patients with CH-C.
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