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.

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